Rossum v. I-Flow Corp.

Full title: Kimberly I. Rossum and Randy Rossum, Plaintiffs, v. I-Flow Corporation…

Court: United States District Court, D. Minnesota

Date published: Aug 1, 2011

Civil No. 09-3714 (JNE/LIB) (D. Minn. Aug. 1, 2011)

Opinion

Civil No. 09-3714 (JNE/LIB).

August 1, 2011

Yvonne M. Flaherty, Esq., and Nathan D. Prosser, Esq., Lockridge Grindal Nauen PLLP, appeared for Plaintiffs Kimberly I. Rossum and Randy Rossum.

Christian M. Ryba, Esq., Segal McCambridge Singer Mahoney, and Benjamin A. Johnson, Esq., Johnson Lindberg, PA, appeared for Defendant I-Flow Corporation.

ORDER

JOAN ERICKSEN, District Judge

Plaintiffs Kimberly I. Rossum and Randy Rossum brought this medical malpractice lawsuit against Defendant I-Flow Corporation, alleging that a pain pump manufactured by I-Flow caused permanent degeneration of cartilage in Kimberly Rossum's shoulder. Pending before the Court is I-Flow's motion to dismiss counts I-III, and VI of the Amended Complaint. See Fed.R.Civ.P. 12(b)(6). I-Flow argues that Plaintiffs' negligent misrepresentation and fraud counts (II and III, respectively) are preempted, and if they are not preempted, that they are not pled with sufficient particularity under Federal Rule of Civil Procedure 9. I-Flow also argues that Plaintiffs' negligence and implied warranty counts (I and VI, respectively) should be dismissed because they merge with Plaintiffs' strict liability claims. For the reasons stated below, the Court rejects I-Flow's arguments and denies its motion to dismiss.

I. BACKGROUND ¹

1 The facts stated below are as pled in the Amended Complaint.

Defendant "designed, tested, manufactured, assembled, labeled, marketed, distributed, promoted, and sold" the On-Q PainBuster pain pump. A pain pump is a medical device that delivers a continuous dose of pain medication via catheter to a site within the body. In May 2005 Kimberly Rossum underwent shoulder surgery, which was performed by Dr. Phillip L. Prosapio. During the surgery, Dr. Prosapio installed the catheter tip of an On-Q pain pump in the joint space of Kimberly Rossum's repaired shoulder. I-Flow's representatives made representations and omissions to Dr. Prosapio regarding the safety of using the On-Q pain pump in joint spaces. Based on I-Flow's representations, Dr. Prosapio, or someone under his supervision, ordered that the On-Q pain pump be used after shoulder surgeries, including placement of the catheter in joint space. (Am. Compl. ¶¶ 25-28) Plaintiffs allege that I-Flow "misled the medical community, and the general public, by making false representations about the safety of their Pain Pump." (Am. Compl. ¶ 36) The On-Q pain pump was not safe for use in joint space, and it caused chondrolysis in Kimberly Rossum's shoulder, irreversibly destroying all or nearly all of the cartilage in it, necessitating multiple surgeries and life-long medication, and causing extreme pain and difficulty in performing basic, daily tasks.

Plaintiffs also allege that in the 1990s I-Flow attempted to obtain § 510(k)² approval from the Food and Drug Administration (FDA) to market I-Flow's pain pumps for use in joint space. The FDA denied § 510(k) approval and required I-Flow to obtain Premarket Approval (PMA) to market I-Flow's pain pumps for use in joint space. I-Flow continued to promote and design its pain pumps for use in joint space even though its request for § 510(k) approval was denied and even though it knew that the pain pumps could cause chondrolysis.

2 The 1976 Medical Device Amendments (MDA) established various levels of oversight for medical devices depending on the devices' risks.

Class I, which includes such devices as elastic bandages and examination gloves, is subject to the lowest level of oversight: "general controls," such as labeling requirements. Class II, which includes such devices as powered wheelchairs and surgical drapes, is subject in addition to "special controls" such as performance standards and postmarket surveillance measures.

The devices receiving the most federal oversight are those in Class III, which include replacement heart valves, implanted cerebella stimulators, and pacemaker pulse generators. . . .

Although the MDA established a rigorous regime of premarket approval for new Class III devices, it grandfathered many that were already on the market. Devices sold before the MDA's effective date may remain on the market until the FDA promulgates, after notice and comment, a regulation requiring premarket approval. A related provision seeks to limit the competitive advantage grandfathered devices receive. A new device need not undergo premarket approval if the FDA finds it is "substantially equivalent" to another device exempt from premarket approval. The agency's review of devices for substantial equivalence is known as the § 510(k) process, named after the statutory provision describing the review.

Riegel v. Medtronic, Inc., 552 U.S. 312, 316-17 (2008) (citations omitted).

The Amended Complaint does not explicitly state whether the On-Q pain pump is a Class I, II, or III medical device. Nor does the Amended Complaint explicitly state whether the On-Q pain pump had PMA. Reading the Amended Complaint as a whole, including the paragraphs covering the attempt to obtain § 510(k) approval, however, the Court infers that there was no PMA covering the On-Q pain pump during the pertinent period. The Court also notes that it found no record of PMA for the On-Q pain pump in the FDA's online PMA database.³ See Mulvenon v. Greenwood, No. 10-1957, 2011 WL 2272134, at *3 (8th Cir. June 10, 2011) ("In addressing a motion to dismiss, '[t]he court may consider the pleadings themselves, materials embraced by the pleadings, exhibits attached to the pleadings, and matters of public record.'" (alteration in original) (citation omitted)). Further, during the motion hearing, Plaintiffs' counsel indicated that the On-Q pain pump was a class II device; Defendant's counsel did not object or contradict this assertion.

3 The Court went to http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm, entered "On-Q" in the "Trade Name" search field, and clicked the search button. The search produced no matching results. (A copy of the webpage showing the results of this search is attached to this Order as Exhibit 1.) The website does, however, indicate that the On-Q pain pump received § 510(k) clearance no later than 2007. January 2007 510(k) Clearances, FDA, http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/ucm083773.htm (last visited July 21, 2011). (A copy of this webpage is attached to this Order as Exhibit 2.)

II. DISCUSSION

When ruling on a motion to dismiss for failure to state a claim pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure, a court must accept the facts alleged in the complaint as true and grant all reasonable inferences in favor of the plaintiff. Crooks v. Lynch, 557 F.3d 846, 848 (8th Cir. 2009). Although a complaint is not required to contain detailed factual allegations, "[a] pleading that offers 'labels and conclusions' or 'a formulaic recitation of the elements of a cause of action will not do.'" Ashcroft v. Iqbal, 129 S. Ct. 1937, 1949 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007)). "To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to 'state a claim to relief that is plausible on its face.'" Id. (quoting Twombly, 550 U.S. at 570). "A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Id.

A. Preemption

In its memorandum in support of its motion to dismiss, I-Flow argues that Plaintiffs' misrepresentation and fraud claims are impliedly preempted under Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001). In its Reply, however, I-Flow argues that some of Plaintiffs' claims are expressly preempted under the MDA. See 21 U.S.C. § 360k(a) (2006); Riegel, 552 U.S. 312. Both parties addressed the express preemption issue at oral argument. The Reply is unclear as to which counts I-Flow directs its express preemption argument. In the preemption section of the Reply, I-Flow asserts that any claims based on a duty to test or failure to warn are expressly preempted. (Reply 3-5) But I-Flow has not moved for the dismissal of Plaintiffs' failure-to-warn strict-liability count and it did not argue in its opening memorandum that any claims other than the misrepresentation and fraud claims were preempted. Accordingly, I-Flow's express preemption arguments are interpreted to be directed at the negligent misrepresentation and fraud counts.

1. Implied preemption

In Buckman, the United States Supreme Court held that "fraud-on-the-[FDA]" claims were impliedly preempted. 531 U.S. at 353. Plaintiffs' misrepresentation and fraud claims are based on representations made to Kimberly Rossum's physician, not the FDA. Accordingly, the claims are not preempted under Buckman. Lefaivre v. KV Pharm. Co., 636 F.3d 935, 944 (8th Cir. 2011) ("Furthermore, the present case is distinguishable from Buckman because Lefaivre's state-law claims are not fraud-on-the-FDA claims, as they 'focus on [harm] that is allegedly perpetrated against [consumers] rather than the FDA.'" (alteration in original) (citation omitted)).

2. Express preemption

Congress included a provision expressly preempting certain state regulations of medical devices in the MDA:

[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement —

(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and

(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

21 U.S.C. § 360k(a). The Supreme Court addressed the meaning of § 360k(a) in Riegel, a case involving a Class III medical device that had received PMA. The Court used a two-step inquiry to determine whether a state-law cause of action is preempted under § 360k(a). First, courts "must determine whether the Federal Government has established requirements applicable" to the device. Riegel, 552 U.S. at 321. Second, courts "must then determine whether the [plaintiffs'] common-law claims are based upon [state] requirements with respect to the device that are 'different from, or in addition to' the federal ones, and that relate to safety and effectiveness." Id. at 321-22 (quoting § 360k(a)).

Regarding the first step, the Riegel Court held that the federal government had established requirements applicable to the device at issue because the device had PMA, which resulted in requirements on manufacturing, labeling, and marketing. A device that has received PMA must "be made with almost no deviations from the specifications in its approval application, for the reason that the FDA has determined that the approved form provides a reasonable assurance of safety and effectiveness." Id. at 323. Regarding the second step, the Riegel Court held that state common-law duties impose requirements that, notwithstanding their general nature, are "with respect to" medical devices. Id. at 323-30. The state common-law duties in Riegel were therefore preempted.

Here, there is no PMA. And, accepting all facts in the Amended Complaint as true and granting all reasonable inferences to Plaintiffs, the Court concludes that any requirements that may apply to the On-Q pain pump under FDA regulations "are not requirements specific to the device in question — they reflect[] 'entirely generic concerns about device regulation generally.'" Id. at 322 (quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 501 (1996)) (emphasis added). Accordingly, I-Flow's Riegel preemption argument fails on the first prong.

The device in Lohr had received § 510(k) approval but not PMA. Although the Lohr Court "disclaimed a conclusion that general federal requirements could never pre-empt, or general state duties never be pre-empted," it "held that no pre-emption occurred in the case at hand based on a careful comparison between the state and federal duties at issue." Id. The Lohr Court reasoned:

Such a comparison mandates a conclusion that the Lohrs' common-law claims are not pre-empted by the federal labeling and manufacturing requirements. The generality of those requirements make this quite unlike a case in which the Federal Government has weighed the competing interests relevant to the particular requirement in question, reached an unambiguous conclusion about how those competing considerations should be resolved in a particular case or set of cases, and implemented that conclusion via a specific mandate on manufacturers or producers. Rather, the federal requirements reflect important but entirely generic concerns about device regulation generally, not the sort of concerns regarding a specific device or field of device regulation that the statute or regulations were designed to protect from potentially contradictory state requirements.

Similarly, the general state common-law requirements in this suit were not specifically developed "with respect to" medical devices. Accordingly, they are not the kinds of requirements that Congress and the FDA feared would impede the ability of federal regulators to implement and enforce specific federal requirements. The legal duty that is the predicate for the Lohrs' negligent manufacturing claim is the general duty of every manufacturer to use due care to avoid foreseeable dangers in its products. Similarly, the predicate for the failure to warn claim is the general duty to inform users and purchasers of potentially dangerous items of the risks involved in their use. These general obligations are no more a threat to federal requirements than would be a state-law duty to comply with local fire prevention regulations and zoning codes, or to use due care in the training and supervision of a work force. These state requirements therefore escape pre-emption, not because the source of the duty is a judge-made common-law rule, but rather because their generality leaves them outside the category of requirements that § 360k envisioned to be "with respect to" specific devices such as pacemakers. As a result, none of the Lohrs' claims based on allegedly defective manufacturing or labeling are pre-empted by the MDA.

Id.

This Court concludes that this reasoning applies to Plaintiffs' fraud and negligent misrepresentations claims. Further, this conclusion is supported by pre- Riegel and pre- Lohr Eighth Circuit precedent. See Nat'l Bank of Commerce of El Dorado v. Kimberly-Clark Corp., 38 F.3d 988, 997 (8th Cir. 1994) ("Our conclusion . . . finds support in the numerous district court decisions that have held that preemption in the class II regulatory context is limited to the realm in which the FDA has acted."). Plaintiffs' fraud and negligent misrepresentation claims are neither impliedly nor expressly preempted.

B. Particularity under Rule 9(b)

I-Flow argues that Plaintiffs' fraud and negligent misrepresentation claims should be dismissed because they are not pled with the particularity required by Rule 9(b).

Under Rule 9(b), a plaintiff must plead "such matters as the time, place and contents of false representations, as well as the identity of the person making the misrepresentation and what was obtained or given up thereby." In other words, the party must typically identify the "who, what, where, when, and how" of the alleged fraud. This requirement is designed to enable defendants to respond "specifically, at an early stage of the case, to potentially damaging allegations of immoral and criminal conduct." The level of particularity required depends on, inter alia, the nature of the case and the relationship between the parties. "Conclusory allegations that a defendant's conduct was fraudulent and deceptive are not sufficient to satisfy the rule." Rule 9(b) should be read "in harmony with the principles of notice pleading."

BJC Health Sys. v. Columbia Cas. Co., 478 F.3d 908, 917 (8th Cir. 2007) (citations omitted). Accepting all facts in the Amended Complaint as true and granting all reasonable inferences to Plaintiffs, Plaintiffs have alleged that I-Flow or its representatives made false representations to Kimberly Rossum's doctor regarding the safety of the On-Q pain pump for use in joint space. The representations were made before Kimberly Rossum's surgery, and her doctor relied on them in deciding to use the On-Q pain pump in her shoulder's joint space. The On-Q pain pump then caused chondrolysis in Kimberly Rossum's shoulder.

Although there is authority supporting the dismissal of similarly pled pain-pump misrepresentation claims pursuant to Rule 9(b), see Forslund v. Stryker Corp., Civil No. 09-2134 (JRT/JJK), 2010 WL 3905854, at *5 (D. Minn. Sept. 30, 2010), the Court concludes that Plaintiffs' negligent misrepresentation and fraud claims are pled with sufficient particularity. "[T]he rule regarding the pleading of fraud does not require absolute particularity or a recital of the evidence, especially when some matters are beyond the knowledge of the pleader and can only be developed through discovery." 5A Charles Alan Wright Arthur R. Miller, Federal Practice and Procedure § 1298 (3d ed. 2004); see also Abels v. Farmers Commodities Corp., 259 F.3d 910, 921 (8th Cir. 2001) ("Where a plaintiff is not a party to a communication, particularity in pleading may become impracticable."); Michaels Bldg. Co. v. Ameritrust Co., 848 F.2d 674, 680 (6th Cir. 1988) ("Courts have held that the [Rule 9(b) particularity requirement] may be relaxed where information is only within the opposing party's knowledge. Especially in a case in which there has been no discovery, courts have been reluctant to dismiss the action where the facts underlying the claims are within the defendant's control." (citations omitted)). Here, the representations were made by I-Flow or its representatives to Kimberly Rossum's doctor; thus, the degree of particularity which otherwise might be required by Rule 9(b) is tempered because many facts concerning the representations are known only to I-Flow and Dr. Prosapio and are beyond Plaintiffs' reach without discovery. Plaintiffs' fraud and negligent misrepresentation claims pass Rule 9(b) muster. See Strong v. Stryker Corp., Civil No. 10-2315 (MJD/FLN), 2010 WL 4967876, at * 3 (D. Minn. Dec. 1, 2010).

C. Merger of claims

I-Flow argues that Plaintiffs' negligence and breach of implied warranty claims should be dismissed because they merge with Plaintiffs' strict liability claims. Plaintiffs respond that consideration of merger before a factual record is before the Court is premature. I-Flow did not address this argument in its Reply. The Court accepts Plaintiffs' argument on this point. See Bilotta v. Kelley Co., 346 N.W.2d 616, 622 (Minn. 1984).

III. CONCLUSION

Based on the files, records, and proceedings herein, and for the reasons stated above, IT IS ORDERED THAT:

1. I-Flow's motion to dismiss [Docket No. 77] is DENIED.

Dated: July 31, 2011

Exhibit

U.S. Food and Drug Administration

Home Medical Devices Products and Medical Procedures Device Approvals and Clearances

Medical Devices

January 2007 510(k) Clearances

SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL

DECISIONS RENDERED DURING THE PERIOD 01-JAN-2007 THROUGH 31-JAN-2007^{1a 2a 3a 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224 225 226 227 228 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245} DEVICE: A D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR A D ENGINEERING, INC. 510(k) NO: K062027 (SPECIAL) ATTN: JERRY WANG PHONE NO: 408-518-5113 1555 MCCANDLESS DR. SE DECISION MADE: 19-JAN-07 MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCIN UNI-KNEE SYSTEM ACCIN CORPORATION 510(k) NO: K063782 (SPECIAL) ATTN: MICHAEL KVITNITSKY PHONE NO: 973-777-8832 1033 US HIGHWAY 46 EAST SE DECISION MADE: 19-JAN-07 SUITE A204 510(k) SUMMARY AVAILABLE FROM FDA CLIFTON, NJ 07013 DEVICE: AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T AESCULAP, INC. 510(k) NO: K062009 (TRADITIONAL) ATTN: MATTHEW M HULL PHONE NO: 610-984-9072 3773 CORPORATE PKWY. SE DECISION MADE: 17-JAN-07 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 AGAMATRIX 510(k) NO: K063409 (TRADITIONAL) ATTN: CONNIE HERTEL PHONE NO: 603-328-6051 10 MAOR PARKWAY SE DECISION MADE: 12-JAN-07 SALEM, NH 03079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RELIANCE CI PROCESS INDICATOR ALBERT BROWNE LTD. 510(k) NO: K063285 (TRADITIONAL) ATTN: CYNTHIA J.M. NOLTE PHONE NO: 919-859-4207 49 PLAIN STREET SE DECISION MADE: 12-JAN-07 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMOGARD THERMAL REGULATION SYSTEM ALSIUS CORP. 510(k) NO: K063829 (SPECIAL) ATTN: KENNETH A COLLINS PHONE NO: 949-453-0150 15770 LAGUNA CANYON, SUITE 150 SE DECISION MADE: 22-JAN-07 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX ALVEOLUS, INC. 510(k) NO: K062511 (TRADITIONAL) ATTN: DONALD CANAL PHONE NO: 704-926-4850 9013 PERIMETER WOODS DRIVE SE DECISION MADE: 31-JAN-07 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA CHARLOTTE, NC 28216 DEVICE: ALEXIS WOUND RETRACTOR APPLIED MEDICAL RESOURCES 510(k) NO: K062907 (TRADITIONAL) ATTN: CHERYL BLAKE PHONE NO: 949-713-8000 22872 AVENIDA EMPRESA SE DECISION MADE: 09-JAN-07 RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AR1000 ULTRASONIC WOUND THERAPY SYSTEM AROBELLA MEDICAL, LLC 510(k) NO: K062544 (TRADITIONAL) ATTN: ALLISON SCOTT PHONE NO: 317-569-9500 11460 N. MERIDIAN STREET SE DECISION MADE: 03-JAN-07 SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA CARMEL, IN 46032 DEVICE: ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS ARTHREX, INC. 510(k) NO: K063058 (TRADITIONAL) ATTN: NANCY HOFT PHONE NO: 239-643-5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 03-JAN-07 NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY ARTHROSURFACE, INC. 510(k) NO: K063370 (TRADITIONAL) ATTN: DAWN J WILSON PHONE NO: 508-520-3003 28 FORGE PARKWAY SE DECISION MADE: 12-JAN-07 FRANKLIN, MA 02038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASAHI PTCA GUIDE WIRE, FIELDER FC ASAHI INTECC CO., LTD. 510(k) NO: K063819 (SPECIAL) ATTN: YOSHI TERAI PHONE NO: 949-756-8252 1301 DOVE STREET SE DECISION MADE: 26-JAN-07 SUITE 350 510(k) SUMMARY AVAILABLE FROM FDA NEWPORT BEACH, CA 92660 DEVICE: REPROCESSED TROCARS ASCENT HEALTHCARE SOLUTIONS 510(k) NO: K062497 (TRADITIONAL) ATTN: ELIZABETH RENKIN PHONE NO: 480-763-5394 10232 SOUTH 51ST ST. SE DECISION MADE: 31-JAN-07 PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATRICURE ABLATION SYSTEM ATRICURE, INC. 510(k) NO: K063630 (TRADITIONAL) ATTN: ELSA C ABRUZZO PHONE NO: 513-755-4130 6033 SCHUMACHER PARK DR. SE DECISION MADE: 26-JAN-07 WEST CHESTER, OH 45069 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES AXON SYSTEMS, INC. 510(k) NO: K062996 (TRADITIONAL) ATTN: HOWARD BAILIN PHONE NO: 631-436-5112 400-2200 OSER AVE. SE DECISION MADE: 12-JAN-07 HAUPPAUGE, NY 11788 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AYCAN WORKSTATION OSIRIX AYCAN DIGITALSYSTEME GMBH 510(k) NO: K063470 (TRADITIONAL) ATTN: CARL ALLETTO PHONE NO: 940-300-8601 1600 MANCHESTER WAY SE DECISION MADE: 05-JAN-07 CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BWF-5 MEDICAL LASER SERIES, 810 NM; 930 NM; 980 NM; 1080 NM B W TEK, INC. 510(k) NO: K062363 (TRADITIONAL) ATTN: SEAN WANG PHONE NO: 302-368-7824 19 SHEA WAY, SUITE 301 SE DECISION MADE: 17-JAN-07 NEWARK, DE 19713 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL) B. BRAUN MEDICAL, INC. 510(k) NO: K063217 (TRADITIONAL) ATTN: PAUL O'CONNELL PHONE NO: 847-274-0097 824 TWELFTH AVE. SE DECISION MADE: 12-JAN-07 BETHLEHEM, PA 18018 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K BAXTER HEALTHCARE CORP. 510(k) NO: K052973 (TRADITIONAL) ATTN: JOHN MANARIK PHONE NO: 847-473-6294 1620 WAUKEGAN ROAD SE DECISION MADE: 25-JAN-07 MCGAW PARK, IL 60085-6730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, BAYLIS MEDICAL CO., INC. 510(k) NO: K062937 (TRADITIONAL) ATTN: MEGHAL KHAKHAR PHONE NO: 905 602 4875 2580 MATHESON BLVD. E SE DECISION MADE: 08-JAN-07 MISSISSAUGA, ONTARIO, CANADA L4W 4510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTAZIDIME (GN) 0.5-6 BECTON DICKINSON CO. 510(k) NO: K063573 (TRADITIONAL) ATTN: VICKI KENNEDY WHITLEY PHONE NO: 410-316-4161 7 LOVETON CIR. SE DECISION MADE: 11-JAN-07 SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM — CEFPODOXIME (GN) 0.12 BECTON, DICKINSON CO. 510(k) NO: K063300 (TRADITIONAL) ATTN: VICKI K WHITLEY PHONE NO: 410-316-4161 7 LOVETON CIR. SE DECISION MADE: 29-JAN-07 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LANDLEX, MODEL S403X BESTEAM TECHNOLOGY INC. 510(k) NO: K063196 (TRADITIONAL) ATTN: JUNNATA CHANG PHONE NO: 886 4 22465396 14F-2 NO. 1 LANE 25 SE DECISION MADE: 23-JAN-07 ZHUANGJING RD. 510(k) SUMMARY AVAILABLE FROM FDA BANQIAO, CHINA (TAIWAN) 220 DEVICE: SHARPS CONTAINER, MODEL 039-413 BIODEX MEDICAL SYSTEMS, INC. 510(k) NO: K063666 (TRADITIONAL) ATTN: CLYDE SCHLEIN PHONE NO: 631-924-9000 20 RAMSAY RD. SE DECISION MADE: 25-JAN-07 SHIRLEY, NY 11967 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND A BIOKIT S.A. 510(k) NO: K060818 (TRADITIONAL) ATTN: JOAN GUIXER PHONE NO: 349 386 090 CAN MALE S/N SE DECISION MADE: 23-JAN-07 LLISSA D'AMUNT 510(k) SUMMARY AVAILABLE FROM FDA BARCELONA, SPAIN 08186 DEVICE: EZLASE BIOLASE TECHNOLOGY, INC. 510(k) NO: K061898 (TRADITIONAL) ATTN: IOANA M RIZOIU PHONE NO: 949-361-1200 4 CROMWELL SE DECISION MADE: 26-JAN-07 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 GRAM POSITIVE AMOXICILLIN FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC. 510(k) NO: K063597 (TRADITIONAL) ATTN: JOLYN TENLLADO PHONE NO: 314-731-8386 595 ANGLUM RD. SE DECISION MADE: 19-JAN-07 HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC. 510(k) NO: K063623 (TRADITIONAL) ATTN: JOLYN TENLLADO PHONE NO: 314-731-8386 595 ANGLUM RD. SE DECISION MADE: 11-JAN-07 HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND BIOMET MANUFACTURING CORP. 510(k) NO: K062998 (TRADITIONAL) ATTN: JING XIE PHONE NO: 574-267-6639 PO BOX 587 SE DECISION MADE: 19-JAN-07 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROPLASTY TIBIAL TRAYS BIOMET MANUFACTURING CORP. 510(k) NO: K063732 (TRADITIONAL) ATTN: BECKY EARL PHONE NO: 574-267-6639 PO BOX 587 SE DECISION MADE: 18-JAN-07 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIAGE PROTEIN C TEST BIOSITE INCORPORATED 510(k) NO: K062530 (TRADITIONAL) ATTN: FIL V BUENVIAJE PHONE NO: 858-805-2722 9975 SUMMERS RIDGE RD SE DECISION MADE: 29-JAN-07 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOTOP HOOKSAFE U-100 INSULIN SYRINGE, MODELS 0.5CC/ML AND 1CC/M BIOTOP TECHNOLOGY CO., LTD. 510(k) NO: K062318 (TRADITIONAL) ATTN: LYDIA LEE PHONE NO: 886 2 23957606 CHUNG-HSIAO E. ROAD, SEC. 2 SE DECISION MADE: 03-JAN-07 12F-2, NO. 130 510(k) SUMMARY AVAILABLE FROM FDA TAIPEI, CHINA (TAIWAN) 100 DEVICE: DUET SYSTEM BIOVIEW LTD. 510(k) NO: K061602 (TRADITIONAL) ATTN: DORIT WINITZ PHONE NO: 972 361 232981 7 JABOTINSKY ST. SE DECISION MADE: 23-JAN-07 RAMAT GAN, ISRAEL 52520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACE BOND SE BISCO, INC. 510(k) NO: K063780 (SPECIAL) ATTN: BENJAMIN LICHTENWALNER PHONE NO: 847-534-6146 1100 WEST IRVING PARK RD. SE DECISION MADE: 19-JAN-07 SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BONART ART-L3 LED CURING LIGHT BONART CO. LTD. 510(k) NO: K062289 (TRADITIONAL) ATTN: ERIC L ONG PHONE NO: 909-594-8066 398 S. LEMON CREEK DR. SE DECISION MADE: 03-JAN-07 STE. L 510(k) STATEMENT WALNUT, CA 91789 DEVICE: MODIFICATION TO VECTORVISION TRAUMA BRAINLAB, AG 510(k) NO: K062358 (SPECIAL) ATTN: RAINER BIRKENBACH PHONE NO: 498 999 15680 KAPELLENSTR. 12 SE DECISION MADE: 17-JAN-07 FELDKIRCHEN, GERMANY 85622 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BREAS ISLEEP 20I BREAS MEDICAL AB 510(k) NO: K063476 (SPECIAL) ATTN: KARL-JOHAN HOLM PHONE NO: 46 318 68800 FORETAGSVAGEN 1 SE DECISION MADE: 22-JAN-07 MOLNLYCKE, SWEDEN 435 33 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLASS LOSS OF RESISTANCE SYRINGE BUSSE HOSPITAL DISPOSABLES, INC. 510(k) NO: K063018 (TRADITIONAL) ATTN: MUHAMAD ANSARI PHONE NO: 631-435-4711 75 ARKAY DR. SE DECISION MADE: 22-JAN-07 HAUPPAUGE, NY 11788 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETER C.R. BARD, INC. 510(k) NO: K063377 (TRADITIONAL) ATTN: MICHAELA RIVKOWICH PHONE NO: 801-595-0700 5425 WEST AMELIA EARHART DR. SE DECISION MADE: 25-JAN-07 SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER C.R. BARD, INC. 510(k) NO: K063632 (SPECIAL) ATTN: TERRI MORRIS PHONE NO: 678-342-4922 13183 HARLAND DRIVE SE DECISION MADE: 05-JAN-07 COVINGTON, GA 30014-6421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CF-1 CANON, INC. 510(k) NO: K063717 (TRADITIONAL) ATTN: SHEILA DRISCOLL PHONE NO: 516-328-5602 ONE CANON PLAZA SE DECISION MADE: 23-JAN-07 LAKE SUCCESS, NY 11042-1198 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM CARDICA, INC. 510(k) NO: K063644 (SPECIAL) ATTN: TIFFINI LALUDE PHONE NO: 650-331-7153 900 SAGINAW DR. SE DECISION MADE: 11-JAN-07 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CIRRUS HD-OCT, MODEL 4000 CARL ZEISS MEDITEC INC 510(k) NO: K063378 (TRADITIONAL) ATTN: JUDITH A BRIMACOMBE PHONE NO: 925-557-4616 5160 HACIENDA DR. SE DECISION MADE: 26-JAN-07 DUBLIN, CA 94568 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT CATACHEM, INC. 510(k) NO: K062503 (TRADITIONAL) ATTN: LUIS P LEON PHONE NO: 203-335-9277 955 CONNECTICUT AVENUE SE DECISION MADE: 19-JAN-07 SUITE 4106 510(k) STATEMENT BRIDGEPORT, CT 06607 DEVICE: OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTI CEREMED INC. 510(k) NO: K070093 (SPECIAL) ATTN: TADEUSZ WELLISZ M.D. PHONE NO: 310-815-2125 3643 LENAWEE AVE. SE DECISION MADE: 24-JAN-07 LOS ANGELES, CA 90016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED MERCI RETRIEVER, MODEL 90050 CONCENTRIC MEDICAL, INC. 510(k) NO: K062046 (TRADITIONAL) ATTN: KIRSTEN VALLEY PHONE NO: 650-938-2100 1380 SHOREBIRD WAY SE DECISION MADE: 19-JAN-07 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO MERCI RETRIEVER, MODELS X5 AND X6 CONCENTRIC MEDICAL, INC. 510(k) NO: K063774 (SPECIAL) ATTN: KIRSTEN VALLEY PHONE NO: 650-938-2100 1380 SHOREBIRD WAY SE DECISION MADE: 24-JAN-07 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONMED ABC DISSECTING BLADE ELECTRODE, MODEL 139330; BLUNT NEEDL CONMED CORPORATION 510(k) NO: K062082 (TRADITIONAL) ATTN: SHAWN RIEDEL PHONE NO: 303-269-8224 14603 E. FREMONT AVE. SE DECISION MADE: 25-JAN-07 CENTENNIAL, CO 80112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONMED LINVATEC 24K IRRIGATION SYSTEM CONMED LINVATEC 510(k) NO: K063326 (TRADITIONAL) ATTN: SUE F DAUTERMAN PHONE NO: 727-399-5321 11311 CONCEPT BOULEVARD SE DECISION MADE: 31-JAN-07 LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR CUSTOM ULTRASONICS 510(k) NO: K061430 (TRADITIONAL) ATTN: LAWRENCE F MUSCARELLA PHONE NO: 215-364-1477 144 RAILROAD DR. SE DECISION MADE: 12-JAN-07 IVYLAND, PA 18974 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: YAG MIR II LASER CYNOSURE, INC. 510(k) NO: K070063 (SPECIAL) ATTN: GEORGE CHO PHONE NO: 978-256-4200 5 CARLISLE ROAD SE DECISION MADE: 30-JAN-07 WESTFORD, MA 01886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT CYTORI THERAPEUTICS, INC. 510(k) NO: K063235 (TRADITIONAL) ATTN: KENNETH K KLEINHENZ PHONE NO: 858-458-0900 3020 CALLAN ROAD SE DECISION MADE: 24-JAN-07 SAN DIEGO, CA 92121-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3 SERIES PHOTOTHERAPY CABINET DAAVLIN CO. 510(k) NO: K063621 (TRADITIONAL) ATTN: TARA MANSUR PHONE NO: 419-636-6304 205 WEST BEMENT ST. SE DECISION MADE: 17-JAN-07 P.O. BOX 626 510(k) SUMMARY AVAILABLE FROM FDA BRYAN, OH 43506 DEVICE: DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRAT DADE BEHRING, INC. 510(k) NO: K063272 (TRADITIONAL) ATTN: KATHLEEN DRAY-LYONS PHONE NO: 781-826-4551 P.O. BOX 6101 SE DECISION MADE: 26-JAN-07 NEWARK,, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR DADE BEHRING, INC. 510(k) NO: K063322 (TRADITIONAL) ATTN: KATHLEEN DRAY-LYONS PHONE NO: 781-826-4551 GLASGOW SITE, PO BOX 6101 SE DECISION MADE: 24-JAN-07 NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATO DADE BEHRING, INC. 510(k) NO: K063351 (TRADITIONAL) ATTN: KATHLEEN A DRAY-LYONS PHONE NO: 781-826-4551 P.O. BOX 6101 SE DECISION MADE: 22-JAN-07 NEWARK,, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEI DADE BEHRING, INC. 510(k) NO: K063508 (TRADITIONAL) ATTN: HELEN M LEE PHONE NO: 302-631-8706 P.O. BOX 6101 SE DECISION MADE: 23-JAN-07 NEWARK,, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBR DADE BEHRING, INC. 510(k) NO: K063610 (TRADITIONAL) ATTN: KATHLEEN DRAY-LYONS PHONE NO: 781-826-4551 P.O. BOX 6101 SE DECISION MADE: 11-JAN-07 NEWARK,, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHE DATASCOPE CORP. 510(k) NO: K063525 (SPECIAL) ATTN: NANCY COHEN PHONE NO: 973-244-6104 15 LAW DR. SE DECISION MADE: 05-JAN-07 FAIRFIELD, NJ 07004-0011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHASE 3, MODEL DT-1 DATREND SYSTEMS, INC. 510(k) NO: K062099 (TRADITIONAL) ATTN: RON EVANS PHONE NO: 604-291-7747 3531 JACOMBS RD., UNIT 1 SE DECISION MADE: 25-JAN-07 RICHMOND, BRITISH COLUMBIA, CANADA510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENTINEL DEL MAR REYNOLDS MEDICAL, LTD. 510(k) NO: K062397 (SPECIAL) ATTN: GEORGE MYERS PHONE NO: 201-727-1703 377 ROUTE 17 S SE DECISION MADE: 25-JAN-07 HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEN TEK NIGHTGUARD DENTEK ORAL CARE, INC. 510(k) NO: K063483 (TRADITIONAL) ATTN: JEFFREY SHAPIRO PHONE NO: 202-637-5775 555 THIRTEENTH STREET, NW SE DECISION MADE: 23-JAN-07 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARRARA VOLUMIA DENTSPLY INTL. 510(k) NO: K070019 (SPECIAL) ATTN: HELEN LEWIS PHONE NO: 717-845-7511 221 WEST PHILADELPHIA STREET SE DECISION MADE: 26-JAN-07 SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA YORK, PA 17404 DEVICE: DEPUY PEAK FX HIP PLATE DEPUY ORTHOPAEDICS, INC. 510(k) NO: K063509 (TRADITIONAL) ATTN: RHONDA MYER PHONE NO: 574-371-4927 700 ORTHOPAEDIC DRIVE SE DECISION MADE: 04-JAN-07 WARSAW, IN 46582 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. 510(k) NO: K063741 (SPECIAL) ATTN: CHRISTOPHER KLACZYK PHONE NO: 508-828-2852 325 PARAMOUNT DR. SE DECISION MADE: 17-JAN-07 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K063208 (TRADITIONAL) ATTN: DEBBIE M MURRAY PHONE NO: 902 566 1396 16 MCCARVILLE ST. SE DECISION MADE: 19-JAN-07 CHARLOTTETOWN, P.E.I., CANADA C1E 510(k) STATEMENT DEVICE: DIOMED DELTA 25 DIOMED, LTD. 510(k) NO: K063828 (SPECIAL) ATTN: TIM PHIPPS PHONE NO: 44 122 3729300 CAMBRIDGE RESEARCH PARK SE DECISION MADE: 25-JAN-07 BUILDING 2000 510(k) SUMMARY AVAILABLE FROM FDA CAMBRIDGE, CAMBRIDGESHIRE, UNITED KINGDOM CB5 9TE DEVICE: RELIEF ACP ORAL CARE GEL DISCUS DENTAL INC. 510(k) NO: K062176 (TRADITIONAL) ATTN: STEVEN L ZIEMBA PHONE NO: 310-845-8345 8550 HIGUERA ST. SE DECISION MADE: 10-JAN-07 CULVER CITY, CA 90232 510(k) STATEMENT DEVICE: EIGEN DSA 2000 EIGEN 510(k) NO: K063846 (SPECIAL) ATTN: NATALIE J KENNEL PHONE NO: 858-705-0350 13721 VIA TRES VISTA SE DECISION MADE: 26-JAN-07 SAN DIEGO, CA 92129 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEODESIC EEG SYSTEM 300 ELECTRICAL GEODESICS, INCORPORATED510(k) NO: K063797 (SPECIAL) ATTN: LINDA J BOVARD PHONE NO: 541-345-5431 29611 SIMMONS ROAD SE DECISION MADE: 25-JAN-07 EUGENE, OR 97405 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HUMAPEN LUXURA HD ELI LILLY AND CO. 510(k) NO: K063151 (TRADITIONAL) ATTN: LEEANN CHAMBERS PHONE NO: 317-277-1813 LILLY CORPORATE CENTER SE DECISION MADE: 09-JAN-07 INDIANAPOLIS, IN 46285 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SELECT TENS, MODEL 4600S EMPI 510(k) NO: K061650 (TRADITIONAL) ATTN: CARL BEAURLINE PHONE NO: 651-389-0771 599 CARDIGAN RD. SE DECISION MADE: 22-JAN-07 ST. PAUL, MN 55126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VECTRA GENISYS VMS FR ENCORE MEDICAL, L.P. 510(k) NO: K062354 (TRADITIONAL) ATTN: MICHAEL TREAS PHONE NO: 423-870-2281 4717 ADAMS ROAD SE DECISION MADE: 26-JAN-07 HIXSON, TN 37343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENCORE KNEE SYSTEM IFU ENCORE MEDICAL, L.P. 510(k) NO: K063406 (TRADITIONAL) ATTN: TEFFANY HUTTO PHONE NO: 512-834-6225 9800 METRIC BLVD. SE DECISION MADE: 08-JAN-07 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20139-0 ERBE USA, INC. 510(k) NO: K062712 (TRADITIONAL) ATTN: JOHN TARTAL PHONE NO: 770-955-4400 2225 NORTHWEST PKWY. SE DECISION MADE: 26-JAN-07 MARIETTA, GA 30067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HA ETHICON ENDO-SURGERY, LLC 510(k) NO: K063192 (TRADITIONAL) ATTN: ELIZABETH MILLER, MST PHONE NO: 513-337-7146 4545 CREEK ROAD SE DECISION MADE: 30-JAN-07 CINCINNATI, OH 45242 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EUSURE, EUGLUCO EUMED BIOTECHNOLOGY CO., LTD. 510(k) NO: K062892 (TRADITIONAL) ATTN: KE-MIN JEN PHONE NO: 886 3 5208829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 22-JAN-07 HSIN CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIDERFX EMBOLIC PROTECTION DEVICE EV3 INC 510(k) NO: K063785 (SPECIAL) ATTN: DAVID WORRELL PHONE NO: 763-398-7000 9600 54TH AVENUE NORTH SE DECISION MADE: 19-JAN-07 PLYMOUTH, MN 55442-2111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOCOBASE WOUND AND SKIN EMULSION FERNDALE LABORATORIES, INC. 510(k) NO: K060272 (TRADITIONAL) ATTN: RICHARD A HAMER PHONE NO: 248-548-0900 780 WEST EIGHT MILE RD. SE DECISION MADE: 12-JAN-07 FERNDALE, MI 48220 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE CROSSER CATHETER, MODEL CR1100 AND SYSTEM ELECTRONICS, MODEL FLOWCARDIA INC 510(k) NO: K062868 (TRADITIONAL) ATTN: DUSTIN MICHAELS PHONE NO: 408-617-0352 745 N. PASTORIA AVE. SE DECISION MADE: 19-JAN-07 SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GAMBRO QUICKSET BLOODLINES GAMBRO RENAL PRODUCTS 510(k) NO: K063290 (TRADITIONAL) ATTN: THOMAS B DOWELL PHONE NO: 303-231-4094 10810 WEST COLLINS AVE. SE DECISION MADE: 30-JAN-07 LAKEWOOD, CO 80215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GAMBRO POSICLEAR GAMBRO SERVICES, INC. 510(k) NO: K061782 (TRADITIONAL) ATTN: JEFFERY R SHIDEMAN PHONE NO: 952-835-4018 7307 GLOUCHESTER DRIVE SE DECISION MADE: 04-JAN-07 EDINA, MN 55435 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SN GEMORE TECHNOLOGY CO., LTD. 510(k) NO: K062675 (TRADITIONAL) ATTN: TONY C.S. CHANG PHONE NO: 886 2 88091799 11 FL, NO. 29-5, SEC. 2 SE DECISION MADE: 04-JAN-07 CHUNG CHENG E. RD. 510(k) SUMMARY AVAILABLE FROM FDA TAN SHUI, TAIPEI HSIEN, CHINA (TAIWAN) 251 DEVICE: GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199 GEN-PROBE, INC. 510(k) NO: K063451 (TRADITIONAL) ATTN: E. JOSEPH MCMULLEN PHONE NO: 858-410-8649 10210 GENETIC CENTER DR. SE DECISION MADE: 22-JAN-07 SAN DIEGO, CA 92121-4362 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091 GEN-PROBE, INC. 510(k) NO: K063664 (TRADITIONAL) ATTN: E. JOSEPH MCMULLEN PHONE NO: 858-410-8649 10210 GENETIC CENTER DR. SE DECISION MADE: 25-JAN-07 SAN DIEGO, CA 92121-4362 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200 GENERIC MEDICAL DEVICE, INC. 510(k) NO: K063429 (TRADITIONAL) ATTN: MONICA MONTANEZ PHONE NO: 713-523-9630 3906 ROSELAND ST. SE DECISION MADE: 17-JAN-07 HOUSTON, TX 77006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORTABLE X-RAY SYSTEM, MODEL PORT-X II GENORAY CO., LTD. 510(k) NO: K063121 (TRADITIONAL) ATTN: CHARLIE MACK PHONE NO: 931-937-8093 340 SHADY GROVE ROAD SE DECISION MADE: 11-JAN-07 FLINTVILLE, TN 37335 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SEPRAMESH, MODEL 5959-1214 GENZYME CORPORATION 510(k) NO: K063739 (TRADITIONAL) ATTN: MATTHEW HIBBERT PHONE NO: 617-374-7463 500 KENDALL STREET SE DECISION MADE: 17-JAN-07 CAMBRIDGE, MA 02142 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GSO BONE FIXATION FASTENERS GOLD STANDARD ORTHOPAEDICS LLC 510(k) NO: K063589 (TRADITIONAL) ATTN: DAVID BAUGHMAN PHONE NO: 502-581-8770 1226 WEST ROWAN ST. SE DECISION MADE: 31-JAN-07 LOUISVILLE, KY 40203 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAPIDTEG TEG-ACT TEST HAEMOSCOPE CORP. 510(k) NO: K062604 (TRADITIONAL) ATTN: ELI COHEN PHONE NO: 847-588-0453 6231 W. HOWARD ST. SE DECISION MADE: 31-JAN-07 NILES, IL 60714 510(k) STATEMENT DEVICE: 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT HAYES MEDICAL, INC. 510(k) NO: K070061 (SPECIAL) ATTN: LUKE ROSE PHONE NO: 916-355-7156 1115 WINDFIELD WAY, SUITE 100 SE DECISION MADE: 31-JAN-07 EL DORADO HILLS, CA 95762-9623 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR) HL RUBBER INDUSTRIES SDN BHD 510(k) NO: K063524 (TRADITIONAL) ATTN: KENNY HOE PHONE NO: 606 481 1088 LOT 10, KAWASAN SE DECISION MADE: 23-JAN-07 PERINDUSTRIAN DIOH 510(k) STATEMENT KUALA PILAH, NEGERI SEMBILAN, MALAYSIA 72000 DEVICE: TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT HOWMEDICA OSTEONICS 510(k) NO: K063423 (TRADITIONAL) ATTN: SHERYL R BAGALIO PHONE NO: 201-831-5581 325 CORPORATE DRIVE SE DECISION MADE: 22-JAN-07 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVLITE C6 Q-SWITCHED ND:YAG LASER SYSTEM HOYA CONBIO, INC 510(k) NO: K063834 (SPECIAL) ATTN: DONNA TEMPLEMAN PHONE NO: 925-846-0458 1105 SUNSET CREEK LANE SE DECISION MADE: 25-JAN-07 PLEASANTON, CA 94566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLIGHT DENTAL SYSTEMS A-SERIES DENTAL OPERATIVE UNIT HR DENTAL PRODUCTS INC 510(k) NO: K070196 (TRADITIONAL) ATTN: JIM RONALDS PHONE NO: 905 799 0517 21 KENVIEW BLVD, UNIT 9 SE DECISION MADE: 26-JAN-07 BRAMPTON, ONTARIO, CANADA L6T 5G7 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECL I-FLOW CORP. 510(k) NO: K063530 (SPECIAL) ATTN: JAMES J DAL PORTO PHONE NO: 949-206-2700 20202 WINDROW DR. SE DECISION MADE: 26-JAN-07 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IKONISCOPE ONCOFISH BLADDER TEST SYSTEM IKONISYS INC 510(k) NO: K062755 (TRADITIONAL) ATTN: OSCAR SANCHEZ PHONE NO: 203-776-0791 5 SCIENCE PARK SE DECISION MADE: 04-JAN-07 NEW HAVEN, CT 06511 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: X3C DIGITAL RADIOGRAPHIC DETECTOR IMAGING DYNAMICS COMPANY LTD. 510(k) NO: K070079 (SPECIAL) ATTN: SHIRANTHAN SAMARAPPULI PHONE NO: 403 251 9939 2340 PEGASUS WAY, NE SE DECISION MADE: 31-JAN-07 SUITE 151 510(k) SUMMARY AVAILABLE FROM FDA CALGARY, CANADA T2E 8M5 DEVICE: IMC-HEARTWAY, LLC ELECTRIC WHEELCHAIR, MODEL TIARA (P4AS) IMC-HEARTWAY, LLC 510(k) NO: K063475 (ABBREVIATED) ATTN: MICHAEL CHEN PHONE NO: 866-464-9779 6140 MID METRO DRIVE, SUITE 6 SE DECISION MADE: 23-JAN-07 FORT MYERS, FL 33912 510(k) STATEMENT DEVICE: INION CPS/OTPS FREEDOMPLATE INION OY 510(k) NO: K063410 (TRADITIONAL) ATTN: KATI MARTTINEN PHONE NO: 358 323 06600 LAAKARINKATU 2 SE DECISION MADE: 23-JAN-07 TAMPERE, FINLAND 33520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARAMOUNT VBR SYSTEM INNOVATIVE SPINAL TECHNOLOGIES INC510(k) NO: K062759 (TRADITIONAL) ATTN: GINA YEH PHONE NO: 508-452-3520 111FORBES BLVD SE DECISION MADE: 12-JAN-07 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASK INOVEL LLC 510(k) NO: K063747 (TRADITIONAL) ATTN: WILLIAM WARZYNIAK PHONE NO: 866-546-6835 10111 W. JEFFERSON BLVD. SE DECISION MADE: 12-JAN-07 CULVER CITY, CA 90232-3509 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ULTRACLIP II WING AND ULTRACLIP II COIL INRAD 510(k) NO: K063238 (TRADITIONAL) ATTN: MELISSA LALOMIA PHONE NO: 800-558-4647 4375 DONKER COURT S.E. SE DECISION MADE: 30-JAN-07 KENTWOOD, MI 49512 510(k) STATEMENT DEVICE: VOLUMETRIC TOMOGRAPHY INSTRUMENTARIUM DENTAL INC. 510(k) NO: K063773 (TRADITIONAL) ATTN: FRANK KASHINSKI PHONE NO: 414-747-6315 300 WEST EDGERTON AVE. SE DECISION MADE: 31-JAN-07 MILWAUKEE, WI 53207-6025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACL TOP INSTRUMENTATION LABORATORY CO. 510(k) NO: K063679 (SPECIAL) ATTN: CAROL MARBLE PHONE NO: 781-861-4467 113 HARTWELL AVE. SE DECISION MADE: 12-JAN-07 LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTEGRA MOZAIK BONE REGENERATION MATRIX — STRIPS INTEGRA LIFESCIENCES CORP. 510(k) NO: K063124 (TRADITIONAL) ATTN: DIANA M BORDON PHONE NO: 609-936-2240 311 ENTERPRISE DRIVE SE DECISION MADE: 19-JAN-07 PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTELEPACS INTELERAD MEDICAL SYSTEMS INC. 510(k) NO: K070080 (TRADITIONAL) ATTN: ANIBAL JODORCOVSKY PHONE NO: 514 931 6222 460 STE-CATHERINE WEST SE DECISION MADE: 24-JAN-07 SUITE 210 510(k) SUMMARY AVAILABLE FROM FDA MONTREAL QUEBEC, CANADA M3B 1A7 THIRD PARTY REVIEW DEVICE: PENCURE, MODEL VL-7 J. MORITA USA, INC. 510(k) NO: K063529 (TRADITIONAL) ATTN: ROBERT A SILVERMAN PHONE NO: 202-783-5070 1425 K STREET NW SE DECISION MADE: 05-JAN-07 SUITE 1100 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20005 DEVICE: POWERTONE, MODEL PT-11 JOHARI DIGITAL HEALTHCARE, LTD. 510(k) NO: K062439 (TRADITIONAL) ATTN: NISHA JOHARI PHONE NO: 818-878-9291 26540 W. AGOURA ROAD SE DECISION MADE: 08-JAN-07 SUITE 230 510(k) SUMMARY AVAILABLE FROM FDA CALABASES, CA 91302 DEVICE: FEMORAL INTRAFIX SCREW AND SHEATH JOHNSON JOHNSON COMPANY 510(k) NO: K063577 (TRADITIONAL) ATTN: RUTH FORSTADT PHONE NO: 508-977-3988 325 PARAMOUNT DRIVE SE DECISION MADE: 25-JAN-07 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K062918 (TRADITIONAL) ATTN: SUSIE CHEN PHONE NO: 310-348-4201 600 CORPORATE POINTE SE DECISION MADE: 17-JAN-07 5TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA CULVER CITY, CA 90230-7600 DEVICE: KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K063585 (TRADITIONAL) ATTN: SUSIE CHEN PHONE NO: 310-338-8100 600 CORPORATE POINTE SE DECISION MADE: 31-JAN-07 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: V.A.C. FREEDOM CANISTER, MODEL M6275421; V.A.C. ATS CANISTER, MO KCI USA, INC. 510(k) NO: K063590 (SPECIAL) ATTN: CHRISTY HUBBARD OVIATT PHONE NO: 210-255-6105 8023 VANTAGE DR. SE DECISION MADE: 25-JAN-07 SAN ANTONIO, TX 78230-4726 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOGUIDE KMS MEDICAL LLC 510(k) NO: K063654 (TRADITIONAL) ATTN: MARIO ARBESU PHONE NO: 305-266-3388 7290 SW 42ND STREET SE DECISION MADE: 31-JAN-07 MIAMI, FL 33155 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER LABORATOIRES URGO 510(k) NO: K062559 (TRADITIONAL) ATTN: SOPHIE FORTIN PHONE NO: 33 3 80447967 42, RUE DE LONGVIC SE DECISION MADE: 29-JAN-07 CHENOVE, FRANCE 21300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VELURE FAMILY OF DIODE LASERS AND DELIVERY DEVICE ACCESSORIES LASERING S.R.L. 510(k) NO: K063396 (TRADITIONAL) ATTN: ALLEN R HOWES PHONE NO: 925-355-0750 2246 CAMINO RAMON SE DECISION MADE: 17-JAN-07 SAN RAMON, CA 94583 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO EASYSPINE SYSTEM LDR SPINE USA 510(k) NO: K063794 (SPECIAL) ATTN: FLOYD G LARSON PHONE NO: 858-792-1235 11234 EL CAMINO REAL SE DECISION MADE: 24-JAN-07 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92130 DEVICE: HAIRMAX LASERCOMB LEXINGTON INTERNATIONAL, LLC 510(k) NO: K060305 (TRADITIONAL) ATTN: EDWARD BASILE PHONE NO: 202-626-2903 1700 PENNSYLVANIA AVENUE, NW SE DECISION MADE: 18-JAN-07 WASHINGTON, DC 20006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSUFLOW DEVICE, MODEL 6198 LEXION MEDICAL, LLC. 510(k) NO: K063546 (SPECIAL) ATTN: DUANE LLOYD PHONE NO: 651-635-0000 5000 TOWNSHIP PKWY SE DECISION MADE: 10-JAN-07 ST. PAUL, MN 55110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PILOT SPINAL SYSTEM LIFE SPINE 510(k) NO: K063601 (TRADITIONAL) ATTN: REBECCA M BROOKS PHONE NO: 847-884-6117 2400 HASSELL ROAD SE DECISION MADE: 25-JAN-07 SUITE 370 510(k) SUMMARY AVAILABLE FROM FDA HOFFMAN ESTATES, IL 60169 DEVICE: LIFECELL DURAL SUBSTITUTE MATRIX LIFECELL CORP. 510(k) NO: K061208 (TRADITIONAL) ATTN: REY LIBROJO PHONE NO: 908-947-1114 ONE MILLENIUM WAY SE DECISION MADE: 03-JAN-07 BRANCHBURG, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: K-Y BRAND TOUCH MASSAGE 2-IN-1 TINGLING MCNEIL-PPC, INC. 510(k) NO: K062535 (TRADITIONAL) ATTN: NADER FOTOUHI PH.D. PHONE NO: 908-904-3730 199 GRANDVIEW RD. SE DECISION MADE: 26-JAN-07 SKILLMAN, NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRASONIC BIOMETER/PACHYMETER FOR OPTHALMOLOGY ODM 2100 AND ODM MEDA LTD. 510(k) NO: K063433 (TRADITIONAL) ATTN: EDWARD A KROLL PHONE NO: 440-546-9810 5905 FAWN LANE SE DECISION MADE: 29-JAN-07 CLEVELAND, OH 44141 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRASONIC BIOMETER/ PACHYMETER FOR OPHTHALMOLOGY, MODEL ODM 210 MEDA LTD. 510(k) NO: K063472 (TRADITIONAL) ATTN: EDWARD A KROLL PHONE NO: 440-546-9810 5905 FAWN LN. SE DECISION MADE: 31-JAN-07 CLEVELAND, OH 44141 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AG-EDGE, MODEL 91200 MEDEL S.P.A. 510(k) NO: K063103 (ABBREVIATED) ATTN: TERRENCE O'BRIEN PHONE NO: 919-468-9552 112 CAVISTON WAY SE DECISION MADE: 08-JAN-07 CARY, NC 27519 510(k) STATEMENT DEVICE: SONOTIP II ULTRASOUND NEEDLE SYSTEM MEDI-GLOBE CORPORATION 510(k) NO: K070129 (TRADITIONAL) ATTN: SCOTT KARLER PHONE NO: 650-463-2900 110 WEST ORION #136 SE DECISION MADE: 31-JAN-07 TEMPE, AZ 85283 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BEAMAX MEDIC SHARPLIGHT LTD. 510(k) NO: K063249 (TRADITIONAL) ATTN: DAN LAOR PHONE NO: 972 4 8246632 6 SIRENI STREET SE DECISION MADE: 17-JAN-07 HAIFA, ISRAEL 32972 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLICKZIP, MODEL U-100 INSULIN SAFETY SYRINGE MEDICAL DEVICE MANUFACTURER (THAIL510(k) NO: K062780 (ABBREVIATED) ATTN: OYTIP KUNWUNLOP PHONE NO: 661 844 7959 7/145 MOO 4 SE DECISION MADE: 05-JAN-07 AMATA CITY INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA RAYONG, THAILAND 21140 DEVICE: LUMINEX LL LASER SYSTEM MEDICAL LASER SYSTEMS INC 510(k) NO: K063574 (TRADITIONAL) ATTN: MIKI KOLTON PHONE NO: 202-331-3134 800 CONNECTICUT AVE. NW SE DECISION MADE: 29-JAN-07 SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA WAHINGTON, DC 20006 DEVICE: APEXNRG XFR MEDICNRG LTD. 510(k) NO: K063843 (SPECIAL) ATTN: GEORGE J HATTUB PHONE NO: 508-479-6116 291 HILLSIDE AVE. SE DECISION MADE: 03-JAN-07 SOMERSET, MA 02726 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C-JAWS CERVICAL COMPRESSIVE MINI FRAME MEDICREA TECHNOLOGIES 510(k) NO: K062181 (TRADITIONAL) ATTN: J.D. WEBB PHONE NO: 512-388-0199 1001 OAKWOOD BLVD. SE DECISION MADE: 16-JAN-07 ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACTIM PROM AND CONTROLS MEDIX BIOCHEMICA 510(k) NO: K061886 (TRADITIONAL) ATTN: CYNTHIA SINCLAIR PHONE NO: 508-643-0434 49 PLAIN STREET SE DECISION MADE: 25-JAN-07 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAPMAN LAPAROSCOPE MANIPULATOR AND ACCESSORIES, MODEL 900-200 SE MEDSYS, S.A. 510(k) NO: K062968 (SPECIAL) ATTN: JEFF MORGAN PHONE NO: 253-535-9369 13723 DANA LN. EAST SE DECISION MADE: 03-JAN-07 PUYALLUP, WA 98373 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFEPAK 12 DEFIBRILLATOR/MONITOR MEDTRONIC EMERGENCY RESPONSE SYSTE510(k) NO: K063510 (SPECIAL) ATTN: MICHELLE ACKERMANN PHONE NO: 425-867-4744 11811 WILLOWS RD., N.E. SE DECISION MADE: 26-JAN-07 P.O. BOX 97006 510(k) SUMMARY AVAILABLE FROM FDA REDMOND, WA 98073-9706 DEVICE: MODIFICATION TO: SATELLITE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K060415 (TRADITIONAL) ATTN: RICHARD TREHARNE PHONE NO: 219-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 05-JAN-07 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K063417 (SPECIAL) ATTN: LEE GRANT PHONE NO: 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 18-JAN-07 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERETE BLP SMALL FRAGMENT LOCKING BONE PLATE MERETE MEDICAL GMBH 510(k) NO: K063487 (TRADITIONAL) ATTN: DONNA COLEMAN PHONE NO: 914-967-1532 49 PURCHASE STREET SE DECISION MADE: 22-JAN-07 RYE, NY 10580 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOCK IT! ORAL PAIN GEL MERLIN GROUP DBA MCMERLIN DENTAL C510(k) NO: K063148 (TRADITIONAL) ATTN: EILEEN VENNUM PHONE NO: 972-602-3746 1610 W. POLO RD SE DECISION MADE: 17-JAN-07 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA GRAND PRAIRIE, TX 75052 DEVICE: TENDER FIBER MICERIUM S.P.A. 510(k) NO: K063170 (TRADITIONAL) ATTN: EUGENIO MICELI PHONE NO: 39 018 57887870 VIA MARCONI 83 SE DECISION MADE: 12-JAN-07 AVENGO, ITALY 16030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROTEK MEDICAL SURGICAL GOWN/TOGA MICROTEK MEDICAL, INC. 510(k) NO: K062899 (TRADITIONAL) ATTN: THOMAS BONNER PHONE NO: 800-844-0988 512 LEHMBERG RD. SE DECISION MADE: 25-JAN-07 COLUMBUS, MS 39702 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICRUS MICROCOIL SYSTEM, "CASHMERE" MODEL SRC MICRUS ENDOVASCULAR CORPORATION 510(k) NO: K063653 (SPECIAL) ATTN: PATRICK LEE PHONE NO: 408-433-1400 821 FOX LANE SE DECISION MADE: 17-JAN-07 SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER MIMOSA ACOUSTICS, INC. 510(k) NO: K063338 (TRADITIONAL) ATTN: PATRICIA S JENG PHONE NO: 217-367-9740 60 HAZELWOOD DR., SUITE #209 SE DECISION MADE: 04-JAN-07 CHAMPAIGN, IL 61820 510(k) STATEMENT DEVICE: MEPILEX AG ABSORBENT SILICONE-COATED DRESSING MOLNLYCKE HEALTH CARE 510(k) NO: K061554 (TRADITIONAL) ATTN: STEVEN DOWDLEY PHONE NO: 678-250-7930 5550 PEACHTREE PARKWAY SE DECISION MADE: 25-JAN-07 SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA NORCROSS, GA 30092 DEVICE: MOORLDLS LASER DOPPLER LINE SCANNER MOOR INSTRUMENTS LTD. 510(k) NO: K063561 (TRADITIONAL) ATTN: XIABING HUANG PHONE NO: 44 129 735715 MILLWEY SE DECISION MADE: 19-JAN-07 AXMINSTER, DEVON, UNITED KINGDOM E510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOORFLPI FULL-FIELD LASER PERFUSION IMAGER MOOR INSTRUMENTS LTD. 510(k) NO: K063586 (TRADITIONAL) ATTN: XIABING HUANG PHONE NO: 44 129 735715 MILLWEY SE DECISION MADE: 25-JAN-07 AXMINSTER, DEVON, UNITED KINGDOM E510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDICAL IMAGE MANAGEMENT DEVICES FOR VISION TOOLS MTD, INC. 510(k) NO: K063439 (TRADITIONAL) ATTN: CHRISTINE NICHOLS PHONE NO: 973-726-7679 8 CROWNVIEW COURT SE DECISION MADE: 22-JAN-07 SPARTA, NJ 07871 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEATSTITCH NEATCLOSE SUTURING DEVICE NEAT STITCH LTD. 510(k) NO: K063462 (TRADITIONAL) ATTN: YOSSI MUNCHER, PH.D. PHONE NO: 972 462 62876 HAHADAS 1 ST SE DECISION MADE: 12-JAN-07 OR AKIVA, ISRAEL 30600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIPRO SAFETOUCH II GAMMA NIPRO MEDICAL CORP. 510(k) NO: K063721 (SPECIAL) ATTN: JESSICA OSWALD PHONE NO: 305-599-7174 3150 NW 107 AVE. SE DECISION MADE: 12-JAN-07 MIAMI, FL 33172 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SFB AND CFB IMPLANTS — 5.0 PLATFORM NOBEL BIOCARE AB 510(k) NO: K063718 (SPECIAL) ATTN: HERBERT CRANE PHONE NO: 714-282-5074 22715 SAVI RANCH PKWY. SE DECISION MADE: 05-JAN-07 YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NORDIC IMAGE CONTROL AND EVALUATION (NICE) SOFTWARE, VERSION 2.1 NORDICICEMEDICAL AS 510(k) NO: K063539 (TRADITIONAL) ATTN: JAMES W KNOX PHONE NO: 508-643-0434 49 PLAIN ST. SE DECISION MADE: 17-JAN-07 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUTRON THERAPY SYSTEM NORTHERN ILLINOIS UNIV. OUTREACH 510(k) NO: K063691 (TRADITIONAL) ATTN: JONATHAN S KAHAN PHONE NO: 202-637-5794 555 THIRTEENTH ST., NW SE DECISION MADE: 31-JAN-07 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM NOVA BIOMEDICAL CORP. 510(k) NO: K063821 (TRADITIONAL) ATTN: PAUL W MACDONALD, PHD PHONE NO: 781-894-0800 200 PROSPECT ST. SE DECISION MADE: 24-JAN-07 WALTHAM, MA 02454-9141 510(k) STATEMENT DEVICE: SPY IMAGING SYSTEM NOVADAQ TECHNOLOGIES, INC. 510(k) NO: K063345 (TRADITIONAL) ATTN: ALLISON MANNERS PHONE NO: 905 629 3822 2585 SKYMARK AVENUE, STE. 306 SE DECISION MADE: 12-JAN-07 MISSISSAUGA, ONTARIO, CANADA L4W 4510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVASIVE ACP4 SYSTEM NUVASIVE, INC. 510(k) NO: K062590 (SPECIAL) ATTN: LAETITIA COUSIN PHONE NO: 858-909-1868 4545 TOWNE CENTRE CT. SE DECISION MADE: 18-JAN-07 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM NUVASIVE, INC. 510(k) NO: K062765 (SPECIAL) ATTN: LAETITIA COUSIN PHONE NO: 858-909-1968 4545 TOWNE CENTRE CT. SE DECISION MADE: 24-JAN-07 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSFERION OLYMPUS AMERICA, INC. 510(k) NO: K061499 (TRADITIONAL) ATTN: LAURA STORMS-TYLER PHONE NO: 631-844-5688 3500 CORPORATE PKWY. SE DECISION MADE: 26-JAN-07 P.O. BOX 610 510(k) SUMMARY AVAILABLE FROM FDA CENTER VALLEY, PA 18034-0610 DEVICE: OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER OMNIGUIDE, INC. 510(k) NO: K070071 (TRADITIONAL) ATTN: DOUGLAS W WOODRUFF PHONE NO: 617-551-8404 ONE KENDALL SQUARE, BLDG 100 SE DECISION MADE: 25-JAN-07 3RD FLOOR 510(k) SUMMARY AVAILABLE FROM FDA CAMBRIDGE, MA 02139 THIRD PARTY REVIEW DEVICE: VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS ORTHO DEVELOPMENT CORP. 510(k) NO: K062666 (TRADITIONAL) ATTN: WILLIAM J GRIFFIN PHONE NO: 801-619-3470 12187 SOUTH BUSINESS PARK DR. SE DECISION MADE: 25-JAN-07 DRAPER, UT 84020 510(k) STATEMENT DEVICE: EUROPEAN STYLE TAPER, PRESS-FIT HIP STEM ORTHO DEVELOPMENT CORP. 510(k) NO: K062775 (TRADITIONAL) ATTN: WILLIAM J GRIFFIN PHONE NO: 801-619-3470 12187 SOUTH BUSINESS PARK DR. SE DECISION MADE: 16-JAN-07 DRAPER, UT 84020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CA ORTHO-CLINICAL DIAGNOSTICS 510(k) NO: K062165 (TRADITIONAL) ATTN: MARLENE HANNA PHONE NO: 585-453-4041 100 INDIGO CREEK DR. SE DECISION MADE: 05-JAN-07 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TS-BONE HIP TOOL ORTHOPEDIC SCIENCES, INC 510(k) NO: K063709 (SPECIAL) ATTN: JAMES K BRANNON PHONE NO: 562-799-5550 3020 OLD RANCH PARKWAY SE DECISION MADE: 04-JAN-07 SUITE 325 510(k) SUMMARY AVAILABLE FROM FDA SEAL BEACH, CA 90740 DEVICE: INTEGRITY LOW SPEED DENTAL AIR HANDPIECE AND ATTACHMENT, MODELS: OSSEO SCIENTIFIC, LLC 510(k) NO: K070155 (TRADITIONAL) ATTN: MICHAEL FELDMAN PHONE NO: 201-490-5421 3138 VEEDER AVE. SE DECISION MADE: 25-JAN-07 TOMS RIVER, NJ 08753 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: EXPEDITIONARY DELPLOYABLE OXYGEN CONCENTRATION SYSTEM (EDOCS), M PACIFIC CONSOLIDATED INDUSTRIES, L510(k) NO: K061414 (TRADITIONAL) ATTN: GARY CLARK PHONE NO: 951-479-0872 12201 MAGNOLIA AVE. SE DECISION MADE: 22-JAN-07 RIVERSIDE, CA 92503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PAJUNKS STIMULONG TSUI-METHOD SET PAJUNK GMBH MEDIZINTECHNOLOGIE 510(k) NO: K062900 (TRADITIONAL) ATTN: CHRISTIAN QUASS PHONE NO: 49 770 49291586 KARL-HALL-STRASSE 01 SE DECISION MADE: 12-JAN-07 GEISINGEN, BADEN-WURTTEMBERG, GERM510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TROCASYS PAJUNK GMBH MEDIZINTECHNOLOGIE 510(k) NO: K063528 (TRADITIONAL) ATTN: CHRISTIAN QUASS PHONE NO: 49 770 48291 KARL-HALL-STRASSE 01 SE DECISION MADE: 17-JAN-07 GEISINGEN, BADEN-WURTTEMBERG, GERM510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50 PDG PRODUCT DESIGN GROUP, INC. 510(k) NO: K063736 (TRADITIONAL) ATTN: EDWARD A KROLL PHONE NO: 440-546-9810 5905 FAWN LANE SE DECISION MADE: 17-JAN-07 CLEVELAND, OH 44141 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COSMELIGHT PENNTACK ENTERPRISES INC. 510(k) NO: K061720 (TRADITIONAL) ATTN: PABLO PENA PHONE NO: 305-835-0411 3321 N.W. 79TH ST. SE DECISION MADE: 31-JAN-07 MIAMI, FL 33147 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PREMIO PETERS SURGICAL 510(k) NO: K060465 (TRADITIONAL) ATTN: ANNIE LASSERRE PHONE NO: 33 148 106259 42 RUE BENOIT FRACHON SE DECISION MADE: 17-JAN-07 Z.I. LES VIGNES 510(k) SUMMARY AVAILABLE FROM FDA BOBIGNY, FRANCE 93013 DEVICE: HEARTSTART MRX, MODELS M3535A OR M3536A PHILIPS MEDICAL SYSTEMS 510(k) NO: K063375 (SPECIAL) ATTN: DENISE HALEY PHONE NO: 978-659-4358 3000 MINUTEMAN RD. SE DECISION MADE: 11-JAN-07 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5 PHILIPS MEDICAL SYSTEMS 510(k) NO: K063559 (TRADITIONAL) ATTN: JOSEPH S ARNAUDO PHONE NO: 425-482-8958 22100 BOTHELL EVERETT HWY SE DECISION MADE: 04-JAN-07 BOTHELL, WA 98021-8431 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K063781 (TRADITIONAL) ATTN: LYNN HARMER PHONE NO: 425-487-7312 22100 BOTHELL EVERETT HIGHWAY SE DECISION MADE: 05-JAN-07 BOTHELL, WA 98021-8431 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS POLYMER TECHNOLOGY SYSTEMS, INC. 510(k) NO: K070017 (SPECIAL) ATTN: MARGO ENRIGHT PHONE NO: 317-870-5610 7736 ZIONSVILLE RD. SE DECISION MADE: 31-JAN-07 INDIANAPOLIS, IN 46268 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORTLAND COBALT CHROME FEMORAL HEAD PORTLAND ORTHOPAEDICS LIMITED 510(k) NO: K063278 (TRADITIONAL) ATTN: ELAINE DUNCAN PHONE NO: 715-549-6035 P.O. BOX 560 SE DECISION MADE: 12-JAN-07 STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWER EXTENDERS MODEL# PEC200, PES200, PES200S POWER MEDICAL INTERVENTIONS, INC. 510(k) NO: K063746 (SPECIAL) ATTN: BARBARA WHITMAN PHONE NO: 267-775-8151 2021 CABOT BLVD. SE DECISION MADE: 12-JAN-07 LANGHORNE, PA 19047 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DERMATHERAPY, MODEL 22216 PRECISION FABRICS GROUP, INC. 510(k) NO: K061242 (TRADITIONAL) ATTN: PAMELA J WEAGRAFF PHONE NO: 508-528-1745 18 BRIDIE LANE SE DECISION MADE: 25-JAN-07 NORFOLK, MA 02056 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRORHYTHM PROMAP COAXIAL MAPPING CATHETER, MODELS PRI-MAP-15, PR PRORHYTHM 510(k) NO: K061678 (TRADITIONAL) ATTN: JOHN J TALARICO PHONE NO: 631-981-3907 105 COMAC ST. SE DECISION MADE: 12-JAN-07 RONKONKOMA, NY 11779 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM RADIANT MEDICAL 510(k) NO: K063405 (SPECIAL) ATTN: SCOTT A WILSON PHONE NO: 650-298-0748 250 CHESAPEAKE DR. SE DECISION MADE: 08-JAN-07 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOPACS RADIOLOGICAL SPECIALISTS, INC. 510(k) NO: K063294 (TRADITIONAL) ATTN: FRANK MCMURRAY PHONE NO: 818-908-9000 5920 NOBLE AVE. SE DECISION MADE: 24-JAN-07 VAN NUYS, CA 91411 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM RADIOMETER BASEL AG 510(k) NO: K063434 (TRADITIONAL) ATTN: JEAN-PIERRE PALMA PHONE NO: 011 416 12788207 AUSTRASSE 25 SE DECISION MADE: 22-JAN-07 BASEL, SWITZERLAND 4051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COR ANALYZER 1, VERSION 1.4 RCADIA MEDICAL IMAGING LTD. 510(k) NO: K063548 (TRADITIONAL) ATTN: DAN LAOR PHONE NO: 972 4 8246632 DERECH YAFO 157 SE DECISION MADE: 22-JAN-07 HAIFA, ISRAEL 35251 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRAXEL II SR LASER SYSTEM RELIANT TECHNOLOGIES, INC. 510(k) NO: K062303 (TRADITIONAL) ATTN: HEATHER TANNER PHONE NO: 650-641-5861 464 ELLIS ST. SE DECISION MADE: 31-JAN-07 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COBAS INTEGRA C 111 ROCHDIAG 510(k) NO: K063744 (SPECIAL) ATTN: CORINA HARPER PHONE NO: 317-521-3831 9115 HAGUE RD. SE DECISION MADE: 17-JAN-07 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERULOPLASMIN, MODEL 2055953 ROCHE DIAGNOSTICS CORP. 510(k) NO: K062114 (TRADITIONAL) ATTN: CORINA HARPER PHONE NO: 317-521-3831 9115 HAGUE RD. SE DECISION MADE: 31-JAN-07 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COBAS INTEGRA CERULOPLASMIN ROCHE DIAGNOSTICS CORP. 510(k) NO: K062379 (TRADITIONAL) ATTN: CORINA HARPER PHONE NO: 317-521-3831 9115 HAGUE RD. SE DECISION MADE: 31-JAN-07 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COAGUCHEK XS SYSTEM ROCHE DIAGNOSTICS CORP. 510(k) NO: K062925 (TRADITIONAL) ATTN: THERESA BUSH PHONE NO: 317-521-3742 9115 HAGUE RD. SE DECISION MADE: 29-JAN-07 INDIANAPOLIS, IN 46256 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COAGUCHEK XS PT CONTROLS ROCHE DIAGNOSTICS CORP. 510(k) NO: K063823 (TRADITIONAL) ATTN: THERESA AMBROSE BUSH PHONE NO: 307-521-3723 9115 HAGUE RD. SE DECISION MADE: 29-JAN-07 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS SANARUS MEDICAL, INC. 510(k) NO: K062896 (TRADITIONAL) ATTN: ALAN MARQUARDT PHONE NO: 925-460-6080 4696 WILLOW RD. SE DECISION MADE: 03-JAN-07 PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASTRA 300 SDI DIAGNOSTICS, INC. 510(k) NO: K061571 (TRADITIONAL) ATTN: COSIMO CARIOLO PHONE NO: 508-238-7033 10 HAMPDEN DR. SE DECISION MADE: 31-JAN-07 EASTON, MA 02375 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASTRAGUARD PULMONARY FUNCTION FILTER SDI DIAGNOSTICS, INC. 510(k) NO: K062913 (TRADITIONAL) ATTN: COSIMO CARIOLO PHONE NO: 508-238-7033 10 HAMPDEN DR. SE DECISION MADE: 26-JAN-07 EASTON, MA 02375 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS CONTROLS SERADYN INC. 510(k) NO: K062966 (TRADITIONAL) ATTN: JACK ROGERS PHONE NO: 317-610-3823 7998 GEORGETOWN RD. SE DECISION MADE: 12-JAN-07 SUITE 1000 510(k) SUMMARY AVAILABLE FROM FDA INDIANAPOLIS, IN 46268-5260 DEVICE: POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION SHIJIAZHUANG LIANHE SHUNDA PLASTIC510(k) NO: K070044 (TRADITIONAL) ATTN: KATHY LIU PHONE NO: 909-591-7888 3973 SCHAEFER AVE SE DECISION MADE: 29-JAN-07 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO CIRCULATION SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K063762 (TRADITIONAL) ATTN: KRISTIN FROWEIN PHONE NO: 49 919 1189638 SIEMENSSTRASSE 1 SE DECISION MADE: 05-JAN-07 FORCHHEIM, GERMANY D 91301 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ACUSON P10 DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K063761 (TRADITIONAL) ATTN: MICHAELA MAHL PHONE NO: 650-694-5653 1230 SHOREBIRD WAY SE DECISION MADE: 04-JAN-07 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SYNGO MI APPLICATIONS 2007A SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K063826 (SPECIAL) ATTN: FRANK POKROP PHONE NO: 847-304-7516 2501 NORTH BARRINGTON RD. SE DECISION MADE: 12-JAN-07 HOFFMAN ESTATES, IL 60195-7372 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K063803 (TRADITIONAL) ATTN: MICHAELA MAHL PHONE NO: 650-694-5653 1230 SHOREBIRD WAY SE DECISION MADE: 05-JAN-07 P O BOX 7393 510(k) SUMMARY AVAILABLE FROM FDA MOUNTAIN VIEW, CA 94039-7393 THIRD PARTY REVIEW DEVICE: SMITH NEPHEW DUONICS POWER II SHAVER SYSTEM SMITH NEPHEW, INC. 510(k) NO: K062849 (TRADITIONAL) ATTN: KATHLEEN BURNS PHONE NO: 978-474-6301 150 MINUTEMAN RD. SE DECISION MADE: 19-JAN-07 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, SMITHS MEDICAL ASD, INC. 510(k) NO: K063450 (ABBREVIATED) ATTN: BRIAN FARIAS PHONE NO: 603-352-3812 10 BOWMAN DR. SE DECISION MADE: 25-JAN-07 KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S1 SOLARIS MEDICAL TECHNOLOGY, INC. 510(k) NO: K061931 (TRADITIONAL) ATTN: THOMAS KROENKE PHONE NO: 303-956-4232 2355 EAST FLAMINGO ROAD SE DECISION MADE: 31-JAN-07 SUITE 201 G 510(k) SUMMARY AVAILABLE FROM FDA LAS VEGAS, NV 89119 DEVICE: SOMNOSCREEN SOMNOMEDICS GMBH CO. KG 510(k) NO: K060708 (TRADITIONAL) ATTN: CHERITA JAMES PHONE NO: 202-546-1262 719 A STREET NE SE DECISION MADE: 24-JAN-07 WASHINGTON, DC 20002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MIC SORIN GROUP ITALIA S.R.L 510(k) NO: K063255 (TRADITIONAL) ATTN: BARRY SALL PHONE NO: 781-434-4742 200 WEST STREET SE DECISION MADE: 11-JAN-07 WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETE SPIRE BIOMEDICAL INC 510(k) NO: K063431 (TRADITIONAL) ATTN: SHEKHAR D NIMKAR PHONE NO: 781-275-6001 ONE PATRIOTS PARK SE DECISION MADE: 29-JAN-07 BEDFORD, MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STEAMPLUS STEAM INTEGRATOR SPS MEDICAL SUPPLY CORP. 510(k) NO: K063799 (TRADITIONAL) ATTN: GARY J SOCOLA PHONE NO: 585-359-0130 6789 WEST HENRIETTA RD. SE DECISION MADE: 05-JAN-07 RUSH, NY 14543 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT STELKAST COMPANY 510(k) NO: K063211 (TRADITIONAL) ATTN: DAVID J STUMPO PHONE NO: 724-941-6368 200 HIDDEN VALLEY RD. SE DECISION MADE: 18-JAN-07 MCMURRAY, PA 15317 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRAUMANN PREFGEL STRAUMANN USA 510(k) NO: K063812 (SPECIAL) ATTN: LISA M QUAGLIA PHONE NO: 978-747-2575 60 MINUTETEMAN ROAD SE DECISION MADE: 12-JAN-07 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLEX P BONE CEMENT STRYKER ORTHOPAEDICS 510(k) NO: K062553 (TRADITIONAL) ATTN: TIFFANI D ROGERS PHONE NO: 201-831-5612 325 CORPORATE DRIVE SE DECISION MADE: 08-JAN-07 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO HIPSTAR FEMORAL STEM STRYKER ORTHOPAEDICS 510(k) NO: K063822 (SPECIAL) ATTN: TIFFANI ROGERS PHONE NO: 201-831-5612 325 CORPORATE DRIVE SE DECISION MADE: 25-JAN-07 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVE SUPER SAFE PLASTIC PRODUCTS CO., L510(k) NO: K070035 (TRADITIONAL) ATTN: KATHY LIU PHONE NO: 909-591-7888 3973 SCHAEFER AVE SE DECISION MADE: 23-JAN-07 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE SUPER SAFE PLASTIC PRODUCTS CO., L510(k) NO: K070040 (TRADITIONAL) ATTN: KATHY LIU PHONE NO: 909-591-7888 3973 SCHAEFER AVE SE DECISION MADE: 26-JAN-07 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENSEAL PTC TRIO SURGRX, INC. 510(k) NO: K070165 (SPECIAL) ATTN: LINDA OLESON PHONE NO: 650-482-2400 101 SAGINAW DR. SE DECISION MADE: 29-JAN-07 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TISSUE SITE MARKING SYSTEM SUROS SURGICAL SYSTEMS, INC. 510(k) NO: K062528 (TRADITIONAL) ATTN: HEIDI STRUNK PHONE NO: 317-344-7500 6100 TECHNOLOGY CENTER DR. SE DECISION MADE: 26-JAN-07 INDIANAPOLIS, IN 46278 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LINGLOCK SYBRON DENTAL SPECIALTIES 510(k) NO: K061042 (TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO: 949-255-8766 100 BAYVIEW CIRCLE SE DECISION MADE: 19-JAN-07 SUITE 6000 510(k) SUMMARY AVAILABLE FROM FDA NEWPORT BEACH, CA 92660-8915 DEVICE: SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM SYNTHES (USA) 510(k) NO: K063181 (TRADITIONAL) ATTN: DEBORAH L JACKSON PHONE NO: 610-719-6948 1301 GOSHEN PKWY SE DECISION MADE: 05-JAN-07 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES ORACLE SPACER SYNTHES SPINE CO.LP 510(k) NO: K062933 (TRADITIONAL) ATTN: BONNIE J SMITH PHONE NO: 610-719-5725 1302 WRIGHTS LANE EAST SE DECISION MADE: 31-JAN-07 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEVER CHEK TD-3213/ CLEVER CHEK TD-3215/ DR. T TD-3216/ CLEVER TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K062800 (TRADITIONAL) ATTN: PI-SHIOU LI PHONE NO: 886 266 358080 4F, 88, SEC.1, KWANG FU ROAD SE DECISION MADE: 12-JAN-07 SAN CHUNG, TAIPEI, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TECO MICROALBUMIN 2-1 COMBO STRIPS TECO DIAGNOSTICS 510(k) NO: K061419 (TRADITIONAL) ATTN: JIAN VAECHES PHONE NO: 714-693-7788 1268 NORTH LAKEVIEW AVE. SE DECISION MADE: 26-JAN-07 ANAHEIM, CA 92807 510(k) STATEMENT DEVICE: VSPSPN TECRES SPA 510(k) NO: K063438 (TRADITIONAL) ATTN: CHRISTINE BRAUER PHONE NO: 301-545-1990 1700 RESEARCH BOULEVARD SE DECISION MADE: 17-JAN-07 SUITE 220 510(k) SUMMARY AVAILABLE FROM FDA ROCKVILLE, MD 20850 DEVICE: RADIFOCUS GLIDEWIRE ADVANTAGE TERUMO MEDICAL CORP. 510(k) NO: K063372 (SPECIAL) ATTN: MARK UNTERREINER PHONE NO: 410-392-7213 950 ELKTON BLVD. SE DECISION MADE: 19-JAN-07 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM THE ANSPACH EFFORT, INC. 510(k) NO: K061297 (TRADITIONAL) ATTN: JAMES CARBONE PHONE NO: 561-627-1080 4500 RIVERSIDE DR. SE DECISION MADE: 26-JAN-07 PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE THE ANSPACH EFFORT, INC. 510(k) NO: K063688 (SPECIAL) ATTN: JIM BANIC PHONE NO: 561-627-1080 4500 RIVERSIDE DR. SE DECISION MADE: 16-JAN-07 PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPI ELEMENT PLATFORM O 4.0 MM THOMMEN MEDICAL, AG 510(k) NO: K070007 (SPECIAL) ATTN: FLOYD G LARSON PHONE NO: 858-792-1235 11234 EL CAMINO REAL, STE. 200 SE DECISION MADE: 10-JAN-07 SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM TOPEX, INC 510(k) NO: K063456 (TRADITIONAL) ATTN: ANTHONY PELLEGRINA PHONE NO: 203-748-5918 10 PRECISION ROAD SE DECISION MADE: 09-JAN-07 DANBURY, CT 06810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXCEL FLOW TRI DENTAL INNOVATORS 510(k) NO: K063714 (TRADITIONAL) ATTN: LINDA NGUYEN PHONE NO: 714-554-1170 13902 WEST ST., UNIT C SE DECISION MADE: 31-JAN-07 GARDEN GROVE, CA 92843 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENTANA IMAGE ANALYSIS SYSTEM — PATHWAY HER2 (4B5) TRIPATH IMAGING 510(k) NO: K061613 (TRADITIONAL) ATTN: BRYAN J TUCKER PHONE NO: 919-206-7101 4025 STIRRUP CREEK DR. SE DECISION MADE: 10-JAN-07 SUITE 400 510(k) STATEMENT DURHAM, NC 27703 DEVICE: TRU-CABLE TRUPHATEK INTERNATIONAL, LTD. 510(k) NO: K063309 (TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO: 239-498-2155 3460 POINTE CREEK CT. SE DECISION MADE: 12-JAN-07 # 102 510(k) SUMMARY AVAILABLE FROM FDA BONITA SPRINGS, FL 34134 DEVICE: POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING TYCO HEALTHCARE GROUP 510(k) NO: K063536 (TRADITIONAL) ATTN: ROBERT ZOTT PHONE NO: 203-845-4515 150 GLOVER AVE. SE DECISION MADE: 29-JAN-07 NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: U2 HIP STEM, TI PLASMA SPRAY UNITED ORTHOPEDIC CORP. 510(k) NO: K062978 (TRADITIONAL) ATTN: GENE HUANG PHONE NO: 886 3 5773351 57 PARK AVE. 2, SCIENCE PARK SE DECISION MADE: 16-JAN-07 HSINCHU, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASYGLUCO, MODEL IGM-0002 G2 US DIAGNOSTICS, INC. 510(k) NO: K061431 (TRADITIONAL) ATTN: EDWARD LETKO PHONE NO: 212-674-3636 304 PARK AVENUE SOUTH SE DECISION MADE: 12-JAN-07 SUITE 218 510(k) SUMMARY AVAILABLE FROM FDA NEW YORK, NY 10010-4301 DEVICE: INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900 THROUGH 7905 VASCULAR SOLUTIONS, INC. 510(k) NO: K062627 (TRADITIONAL) ATTN: PATRICE STROMBERG PHONE NO: 763-656-4300 6464 SYCAMORE COURT NORTH SE DECISION MADE: 05-JAN-07 MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TWIN-PASS .023 DUAL ACCESS CATHETER, MODEL 5230 VASCULAR SOLUTIONS, INC. 510(k) NO: K062877 (TRADITIONAL) ATTN: JULIE TAPPER PHONE NO: 763-656-4228 6464 SYCAMORE COURT NORTH SE DECISION MADE: 18-JAN-07 MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTO-FILL SYRINGE KIT, MODEL 7600 VASCULAR SOLUTIONS, INC. 510(k) NO: K063851 (TRADITIONAL) ATTN: PATRICE STROMBERG PHONE NO: 763-656-4300 6464 SYCAMORE COURT NORTH SE DECISION MADE: 26-JAN-07 MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERTIFLEX SPINAL SCREW SYSTEM VERTIFLEX (TM), INCORPORATED 510(k) NO: K062670 (TRADITIONAL) ATTN: STEVE REITZLER PHONE NO: 760-448-4800 1954 KELLOGG AVENUE, SUITE 100 SE DECISION MADE: 12-JAN-07 CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZ-MIO STERNAL VIDACARE CORPORATION 510(k) NO: K063567 (TRADITIONAL) ATTN: GRACE HOLLAND PHONE NO: 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 26-JAN-07 IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16 VISION BIOSYSTEMS INC. 510(k) NO: K062615 (ABBREVIATED) ATTN: RONALD F LAGERQUIST PHONE NO: 805-499-6758 1833 PORTOLA ROAD SE DECISION MADE: 29-JAN-07 VENTURA, CA 93003 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERON PLUS VOCO GMBH 510(k) NO: K063554 (ABBREVIATED) ATTN: MICHAEL SUS PHONE NO: 49 472 1719214 ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 12-JAN-07 CUXHAVEN, GERMANY D-27472 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TWINKY STAR NF VOCO GMBH 510(k) NO: K063604 (ABBREVIATED) ATTN: MANFRED THOMAS PLAUMANN PHONE NO: 49 472 17190 ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 22-JAN-07 CUXHAVEN, GERMANY D-27472 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEXTROSCOPE, MODEL MK10; DEXTROBEAM, MODEL MK3, MK4; RADIODEXTER VOLUME INTERACTIONS PTE LTD 510(k) NO: K063730 (SPECIAL) ATTN: VALERIE FAN PHONE NO: 65 622 26962 1 KIM SENG PROMENADE SE DECISION MADE: 31-JAN-07 #12-01 GREAT WORLD CITY EAST 510(k) STATEMENT TOWER, SINGAPORE, SINGAPORE 237994 DEVICE: WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODE WAKO CHEMICALS, USA, INC. 510(k) NO: K062368 (TRADITIONAL) ATTN: LORI CREASY PHONE NO: 804-714-1932 1600 BELLWOOD ROAD SE DECISION MADE: 31-JAN-07 RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT P WALTER LORENZ SURGICAL, INC. 510(k) NO: K063052 (TRADITIONAL) ATTN: KIM REED PHONE NO: 904-741-4400 1520 TRADEPORT DR. SE DECISION MADE: 12-JAN-07 JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUNDERQUIST WIRE GUIDE; DC WIRE GUIDE WILLIAM COOK EUROPE APS 510(k) NO: K061670 (SPECIAL) ATTN: TINA H ANDERSON PHONE NO: 45 56 868760 SANDET 6, DK-4632 SE DECISION MADE: 19-JAN-07 BJAEVERSKOV, DENMARK 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUSION QUATTRO EXTRACTION BALLOON XL WILSON-COOK MEDICAL, INC. 510(k) NO: K063677 (SPECIAL) ATTN: SCOTTIE FARIOLE PHONE NO: 336-744-0157 4900 BETHANIA STATION RD. SE DECISION MADE: 05-JAN-07 WINSTON-SALEM, NC 27105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HILGER DUAL-STIM NERVE STIMULATOR WR MEDICAL ELECTRONICS CO. 510(k) NO: K063560 (ABBREVIATED) ATTN: GARY SYRING PHONE NO: 608-877-2635 800 LAVANGER LANE SE DECISION MADE: 05-JAN-07 STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XODUS MEDICAL ANTI-FOG SOLUTION XODUS MEDICAL, INC. 510(k) NO: K063587 (TRADITIONAL) ATTN: BRENDA NIEL PHONE NO: 724-337-5500 702 PROMINENCE DR. SE DECISION MADE: 09-JAN-07 NEW KENSINGTON, PA 15068 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER Z-MEDICA CORPORATION 510(k) NO: K070010 (SPECIAL) ATTN: GIACOMO BASADONNA PHONE NO: 203-294-0000 4 FAIRFIELD BLVD. SE DECISION MADE: 25-JAN-07 WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES ZIBO HENGDE PLASTIC RUBBER PRODU510(k) NO: K070006 (TRADITIONAL) ATTN: CHU XIAOAN PHONE NO: 86 10 82387441 NO. 209 BEI SI HUAN ZHONG ROAD SE DECISION MADE: 19-JAN-07 BEIJING, CHINA 10083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY ZIMMER, INC. 510(k) NO: K063251 (TRADITIONAL) ATTN: DALENE T BINKLEY PHONE NO: 574-372-4907 P.O. BOX 708 SE DECISION MADE: 24-JAN-07 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 245 TOTAL WITH SUMMARIES 230 TOTAL WITH STATEMENTS 15