SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-SEP-2006 THROUGH 30-SEP-2006
DEVICE: NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIE
ABBOTT SPINE, INC. 510(k) NO: K062505(SPECIAL)
ATTN: NOAH BARTSCH PHONE NO : 512-533-1840
5301 RIATA PARK CT., BLDG. F SE DECISION MADE: 26-SEP-06
AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETHMOID SINUS SPACER
ACCLARENT, INC. 510(k) NO: K062458(TRADITIONAL)
ATTN: DEBBIE COGAN PHONE NO : 650-687-5888
1525-B O'BRIEN DR. SE DECISION MADE: 15-SEP-06
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
ACCURAY INCORPORATED 510(k) NO: K062514(SPECIAL)
ATTN: ANNE SCHLAGENHAFT PHONE NO : 408-716-4628
1310 CHESAPEAKE TERRACE SE DECISION MADE: 28-SEP-06
SUNNYVALE, CA 94089-1100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIE REGION OF INTEREST IMAGE ENHANCEMENT
ADVANCED IMAGE ENHANCEMENT 510(k) NO: K062059(TRADITIONAL)
ATTN: JILLIAN M REED PHONE NO : 203-459-0659
25 WALNUT STREET SE DECISION MADE: 06-SEP-06
MONROE, CT 06468 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
AESCULAP, INC. 510(k) NO: K060762(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 610-984-9072
3773 CORPORATE PKWY. SE DECISION MADE: 14-SEP-06
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AESCULAP NEURO PATTIES
AESCULAP, INC. 510(k) NO: K062406(SPECIAL)
ATTN: LISA M BOYLE PHONE NO : 610-979-9300
3773 CORPORATE PKWY. SE DECISION MADE: 15-SEP-06
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM
AESTHERA CORPORATION 510(k) NO: K062048(TRADITIONAL)
ATTN: ANNE WORDEN PHONE NO : 925-895-1200
3637 BERNAL AVENUE SE DECISION MADE: 07-SEP-06
PLEASANTON, CA 94566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AGFA MODEL CR30-X
AGFA CORPORATION 510(k) NO: K062223(SPECIAL)
ATTN: PATRICK J LYNCH PHONE NO : 864-421-1987
10 SOUTH ACADEMY ST. SE DECISION MADE: 01-SEP-06
GREENVILLE, SC 29601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYSTALVIEW R200
ALARA, INC. 510(k) NO: K062390(SPECIAL)
ATTN: DIANE M KING PHONE NO : 510-315-5200
47505 SEABRIDGE DRIVE SE DECISION MADE: 18-SEP-06
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERAMAX
ALPHADENT CO., LTD. 510(k) NO: K062504(TRADITIONAL)
ATTN: NOH HAK PHONE NO : 82 2 8374840
371-37, GASAN-DONG, SE DECISION MADE: 05-SEP-06
GEUMCHEON-GU 510(k) SUMMARY AVAILABLE FROM FDA
SEOUL, REPUBLIC OF KOREA 153-803 THIRD PARTY REVIEW
DEVICE: PULSE OXIMETER ADAPTER CABLES
AMERICAN I.V. PRODUCTS, INC. 510(k) NO: K052544(ABBREVIATED)
ATTN: GREGORY FALK PHONE NO : 410-787-1300
7485 SHIPLEY AVE. SE DECISION MADE: 29-SEP-06
HANOVER, MD 21076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINI-YAG LASER
AMERICAN LASERS, INC. 510(k) NO: K061850(TRADITIONAL)
ATTN: DAVID K QUON PHONE NO : 626-300-9330
300 EAST MAIN ST. SE DECISION MADE: 29-SEP-06
ALHAMBRA, CA 91801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS
ANULEX TECHNOLOGIES, INC 510(k) NO: K062307(SPECIAL)
ATTN: TIMOTHY MILLER PHONE NO : 952-224-4003
5600 ROWLAND ROAD, STE 280 SE DECISION MADE: 01-SEP-06
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARC SURGICAL BIOTRAK SCREW
ARC SURGICAL LLC. 510(k) NO: K061763(TRADITIONAL)
ATTN: ED BOEHMER PHONE NO : 503-645-9300
21300 NW JACOBSON RD. SE DECISION MADE: 19-SEP-06
HILLSBORO, OR 97124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX ASPIRATE KIT
ARTHREX, INC. 510(k) NO: K062365(TRADITIONAL)
ATTN: SALLY FOUST PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 29-SEP-06
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX CORKSCREW FT III SUTURE ANCHOR WITH THREE #2 SUTURES
ARTHREX, INC. 510(k) NO: K062679(SPECIAL)
ATTN: NANCY HOFT PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 27-SEP-06
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM
ARTHREX, INC. 510(k) NO: K062747(SPECIAL)
ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 29-SEP-06
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE
ARTHROTEK, INC. 510(k) NO: K061776(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 25-SEP-06
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: REPROCESSED EXTERNAL FIXATION DEVICE
ASCENT HEALTHCARE SOLUTIONS 510(k) NO: K061759(TRADITIONAL)
ATTN: AMANDA BABCOCK PHONE NO : 480-763-5300
10232 SOUTH 51ST ST. SE DECISION MADE: 05-SEP-06
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TATTOOSTAR FAMILY
ASCLEPION LASER TECHNOLOGIES GMBH 510(k) NO: K060787(SPECIAL)
ATTN: REINHARD THIEME PHONE NO : 493 641 7700100
1A; IM SEMMICHT SE DECISION MADE: 27-SEP-06
JENA, GERMANY 07751 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V-2200 INFANT INCUBATOR
ATOM MEDICAL INC 510(k) NO: K061856(TRADITIONAL)
ATTN: MARY STANIEWICZ PHONE NO : 215-672-6800
35 COMMERCE DRIVE SE DECISION MADE: 28-SEP-06
IVYLAND, PA 18974 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RB12 SUCTION RECTAL BIOPSY SYSTEM
AUS SYSTEMS PTY LTD. 510(k) NO: K062159(TRADITIONAL)
ATTN: IAN P GORDON PHONE NO : 727-797-4727
2454 MCMULLEN BOOTH RD. SE DECISION MADE: 05-SEP-06
SUITE 427 510(k) SUMMARY AVAILABLE FROM FDA
CLEARWATER, FL 33759
DEVICE: SURGICAL DRAPES
AUSTIN MEDICAL, INC. 510(k) NO: K061422(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
3460 POINTE CREEK CT. SE DECISION MADE: 25-SEP-06
#102 510(k) SUMMARY AVAILABLE FROM FDA
BONITA SPRINGS, FL 34134-2015
DEVICE: TRUMPET VALVE HANDLE WITH 3-METRE TUBING, SINGLE SPIKE, 5MM CANN
AUSTRALIAN SURGICAL DEVICES 510(k) NO: K060182(TRADITIONAL)
ATTN: MARIO KUNA PHONE NO : 612 997 94111
2/11 PONDEROSA PARADE SE DECISION MADE: 07-SEP-06
WARRIEWOOD NSW, AUSTRALIA 2102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXYAFLEX POLYESTER SUTURE
AXYA MEDICAL, INC. 510(k) NO: K060165(TRADITIONAL)
ATTN: HOWARD SCHRAYER PHONE NO : 978-232-9997
100 CUMMINGS CENTER SE DECISION MADE: 01-SEP-06
SUITE 444C 510(k) SUMMARY AVAILABLE FROM FDA
BEVERLY, MA 01915
DEVICE: CORONIS 3MP AND MDCG 3120-CB
BARCOVIEW 510(k) NO: K061924(TRADITIONAL)
ATTN: LIEVEN DE WANDEL PHONE NO : 325 623 3459
35 PRESIDENT KENNEDYPARK SE DECISION MADE: 05-SEP-06
KORTRIJK, BELGIUM B-8500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORONIS COLOR 3MP AND MDCC 3120-DL
BARCOVIEW 510(k) NO: K061927(TRADITIONAL)
ATTN: LIEVEN DE WANDEL PHONE NO : 325 623 3459
35 PRESIDENT KENNEDYPARK SE DECISION MADE: 05-SEP-06
KORTRIJK, BELGIUM B-8500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORONIS COLOR 2MP AND MDCC 2121
BARCOVIEW 510(k) NO: K061928(TRADITIONAL)
ATTN: LIEVEN DE WANDEL PHONE NO : 325 623 3459
35 PRESIDENT KENNEDYPARK SE DECISION MADE: 05-SEP-06
KORTRIJK, BELGIUM B-8500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZYOPTIX XP EPI SEPARATOR SYSTEM
BAUSCH & LOMB, INC. 510(k) NO: K062465(TRADITIONAL)
ATTN: NED LUCE PHONE NO : 585-338-6368
1400 NORTH GOODMAN ST. SE DECISION MADE: 06-SEP-06
ROCHESTER, NY 14609 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RENALSOFT
BAXTER HEALTHCARE CORP. 510(k) NO: K061515(TRADITIONAL)
ATTN: DAVID E CURTIN PHONE NO : 847-473-6079
1620 WAUKEGAN RD SE DECISION MADE: 11-SEP-06
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES
BAXTER HEALTHCARE CORPORATION 510(k) NO: K062457(SPECIAL)
ATTN: NANETTE HEDDEN PHONE NO : 847-473-6281
1620 WAUKEGAN RD. SE DECISION MADE: 21-SEP-06
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP,
BAYER HEALTHCARE 510(k) NO: K062058(TRADITIONAL)
ATTN: ROGER SONNENBERG PHONE NO : 574-262-7152
430 SOUTH BEIGER STREET SE DECISION MADE: 11-SEP-06
MISHAWAKA, IN 46544 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD FACSCANTO II FLOW CYTOMETER (4-2 CONFIGURATION), MODEL 33896
BD BIOSCIENCES 510(k) NO: K062087(SPECIAL)
ATTN: CARTER NAVARRO PHONE NO : 408-954-2469
2350 QUME DR. SE DECISION MADE: 14-SEP-06
SAN JOSE, CA 95131-1807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953
BECKMAN COULTER, INC. 510(k) NO: K061190(TRADITIONAL)
ATTN: VALYNDA L MACHEN PHONE NO : 952-368-1383
1000 LAKE HAZELTINE DR. SE DECISION MADE: 15-SEP-06
CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN (STREP)
BECTON, DICKINSON & CO. 510(k) NO: K062206(TRADITIONAL)
ATTN: JANINE MATLAK PHONE NO : 410-316-4938
7 LOVETON CIR. SE DECISION MADE: 08-SEP-06
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (GN) 1-64
BECTON, DICKINSON & CO. 510(k) NO: K062207(TRADITIONAL)
ATTN: VICKI L KENNEDY PHONE NO : 410-316-4161
7 LOVETON CIR. SE DECISION MADE: 13-SEP-06
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COCHLEA-SCAN / COCHLEA-SCAN PLUS
BIO-LOGIC SYSTEMS CORP. 510(k) NO: K061744(TRADITIONAL)
ATTN: NORMAN BRUNNER PHONE NO : 847-949-5200
ONE BIOLOGIC PLAZA SE DECISION MADE: 15-SEP-06
MUNDELEIN, IL 60060-3700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLOGRAN-R
BIOCOMPOSITES LTD. 510(k) NO: K061311(TRADITIONAL)
ATTN: SIMON FITZER PHONE NO : 440 178 2338580
KEELE SCIENCE PARK SE DECISION MADE: 22-SEP-06
KEELE, STAFFORDSHIRE, UNITED KINGD510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOUBLEPLAY SUTURE ANCHOR
BIOCOMPOSITES LTD. 510(k) NO: K061949(TRADITIONAL)
ATTN: SIMON FITZER PHONE NO : 44 178 2338580
KEELE SCIENCE PARK SE DECISION MADE: 25-SEP-06
KEELE, STAFFORDSHIRE, UNITED KINGD510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAMMOPAD RADIOLUCENT CUSHION
BIOLUCENT, INC. 510(k) NO: K062141(TRADITIONAL)
ATTN: SHERYL HIGGINS PHONE NO : 949-349-1380
6 JOURNEY, SUITE 325 SE DECISION MADE: 13-SEP-06
ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 AST-YS FLUCONAZOLE
BIOMERIEUX, INC. 510(k) NO: K061945(TRADITIONAL)
ATTN: NANCY WEAVER PHONE NO : 314-731-8695
595 ANGLUM DR. SE DECISION MADE: 19-SEP-06
HAZELWOOD, MO 63042-2320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 23 MM SINGLE-PEG PATELLA COMPONENT
BIOMET MANUFACTURING, INC. 510(k) NO: K061340(TRADITIONAL)
ATTN: LESTER F PADILLA PHONE NO : 574-372-1644
56 EAST BELL DR. SE DECISION MADE: 25-SEP-06
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: WELLFLEX BILIARY RX STENT SYSTEM
BOSTON SCIENTIFIC CORP. 510(k) NO: K061231(TRADITIONAL)
ATTN: ALLYSON BARFORD PHONE NO : 508-683-4356
100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 01-SEP-06
MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAXFORCE TTS SINGLE-USE BALLOON DILATOR
BOSTON SCIENTIFIC CORP. 510(k) NO: K061787(TRADITIONAL)
ATTN: WING NG PHONE NO : 508-683-4141
100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 21-SEP-06
MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM
BOSTON SCIENTIFIC CORP. 510(k) NO: K061877(TRADITIONAL)
ATTN: ELENA BICKOFF PHONE NO : 508-683-4347
100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 15-SEP-06
MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
BOSTON SCIENTIFIC CORPORATION 510(k) NO: K062594(SPECIAL)
ATTN: SARAH PETERSON PHONE NO : 763-494-2133
160 KNOWLES DR. SE DECISION MADE: 20-SEP-06
LOS GATOS, CA 95032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOVIE ICON GI ELECTROSURGICAL GENERATOR, MODEL GI 120
BOVIE MEDICAL 510(k) NO: K061884(TRADITIONAL)
ATTN: RICHARD KOZLOFF PHONE NO : 727-803-8513
3200 TYRONE BLVD., STE. A SE DECISION MADE: 06-SEP-06
ST. PETERSBURG, FL 33710-2902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDIBYTE, MODEL MP8
BRAEBON MEDICAL CORP. 510(k) NO: K061764(TRADITIONAL)
ATTN: RICHARD A BONATO PHONE NO : 613 831 6690
120 WALGREEN DR (RR#3) SE DECISION MADE: 06-SEP-06
SUITE #1 510(k) SUMMARY AVAILABLE FROM FDA
CARP, ONTARIO, CANADA K0A 1L0
DEVICE: NAVIVISION
BRAINLAB AG 510(k) NO: K062086(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 49 89 9915680
KAPELLENSTRASSE 12 SE DECISION MADE: 20-SEP-06
FELDKIRCHEN, GERMANY 85622 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EP
BUSSE HOSPITAL DISPOSABLES, INC. 510(k) NO: K061394(TRADITIONAL)
ATTN: MUHAMAD ANSARI PHONE NO : 631-435-4711
75 ARKAY DRIVE SE DECISION MADE: 06-SEP-06
P.O. BOX 11067 510(k) SUMMARY AVAILABLE FROM FDA
HAUPPAUGE, NY 11788
DEVICE: RESOLUTIONMD, VERSION 1.3
CALGARY SCIENTIFIC, INC. 510(k) NO: K062164(TRADITIONAL)
ATTN: PIERRE LEMIRE PHONE NO : 403 270 7159
1210 20TH AVENUE SE SE DECISION MADE: 22-SEP-06
SUITE 208 510(k) SUMMARY AVAILABLE FROM FDA
CALGARY, ALBERTA, CANADA T2G 1M8
DEVICE: SELFCHECK GLUCO
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K061528(TRADITIONAL)
ATTN: ALEX GONOROVSKY PHONE NO : 972 8 9484000
2 PEKERIS ST., SCIENCE PARK SE DECISION MADE: 22-SEP-06
P.O.B. 527 510(k) SUMMARY AVAILABLE FROM FDA
REHOVOT, ISRAEL 76100
DEVICE: BERNOULLI MANAGEMENT SYSTEM (MS) SOFTWARE
CARDIOPULMONARY CORP. 510(k) NO: K061932(TRADITIONAL)
ATTN: JORDAN SCHRECK PHONE NO : 203-301-6227
200 CASCADE BLVD. SE DECISION MADE: 14-SEP-06
MILFORD, CT 06460 510(k) STATEMENT
DEVICE: BOOMERANG WIRE
CARDIVA MEDICAL, INC. 510(k) NO: K061075(SPECIAL)
ATTN: GLENN FOY PHONE NO : 650-964-8900
2585 LEGHORN ST. SE DECISION MADE: 01-SEP-06
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040
CAS MEDICAL SYSTEMS, INC. 510(k) NO: K061960(TRADITIONAL)
ATTN: RON JEFFREY PHONE NO : 203-488-6056
44 EAST INDUSTRIAL RD. SE DECISION MADE: 05-SEP-06
BRANFORD, CT 06405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHASE CARDIAC ANALYSIS SYSTEM
CHASE MEDICAL, LP 510(k) NO: K062031(TRADITIONAL)
ATTN: DAVID M HERNON PHONE NO : 972-783-0644
1876 FIRMAN DR. SE DECISION MADE: 27-SEP-06
RICHARDSON, TX 75081 510(k) STATEMENT
DEVICE: CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-17
CODMAN & SHURTLEFF, INC. 510(k) NO: K061568(SPECIAL)
ATTN: JOCELYN RAPOSO PHONE NO : 508-828-3421
325 PARAMOUNT DR. SE DECISION MADE: 29-SEP-06
RAYNHAM, MA 02767-0350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCD GARMENT, MODEL VP530
COMPRESSION THERAPY CONCEPTS, INC.510(k) NO: K061967(TRADITIONAL)
ATTN: LEN NASS PHONE NO : 908-822-1488
1750 BRIELLE AVE. SE DECISION MADE: 25-SEP-06
SUITE B6 510(k) STATEMENT
WANAMASSA, NJ 07712
DEVICE: ZEUS MALE CONDOM APPLICATOR
CONDAX LLC. 510(k) NO: K052206(ABBREVIATED)
ATTN: ELI J CARTER PHONE NO : 919-544-4098
1219 LITTLE CREEK RD. SE DECISION MADE: 12-SEP-06
PO BOX 12139 510(k) SUMMARY AVAILABLE FROM FDA
DURHAM, NC 27709
DEVICE: CONNECT IMAGING PACS
CONNECT IMAGING, INC. 510(k) NO: K061972(ABBREVIATED)
ATTN: PHILIP J MANLY PHONE NO : 808-373-7048
850 WEST HIND DR., SUITE 116 SE DECISION MADE: 18-SEP-06
HONOLULU, HI 96821-1855 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANO
COOK IRELAND LTD 510(k) NO: K060623(TRADITIONAL)
ATTN: EMMETT DEVEREUX PHONE NO : 353 613 34440
O'HOLLORAN ROAD SE DECISION MADE: 06-SEP-06
NATIONAL TECHNOLOGICAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
LIMERICK, IRELAND
DEVICE: ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI
CORDIS CORP., A JOHNSON & JOHNSON 510(k) NO: K062531(TRADITIONAL)
ATTN: JOAN MARTIN PHONE NO : 908-412-7250
7 POWDERHORN DRIVE SE DECISION MADE: 22-SEP-06
WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYTORI CELUTION CELL CONCENTRATION DEVICE
CYTORI THERAPEUTICS, INC. 510(k) NO: K060482(TRADITIONAL)
ATTN: KENNETH K KLEINHENZ PHONE NO : 858-458-0900
3020 CALLAN ROAD SE DECISION MADE: 28-SEP-06
SAN DIEGO, CA 92121-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR
DADE BEHRING, INC. 510(k) NO: K061795(TRADITIONAL)
ATTN: PAMELA A JUNGA PHONE NO : 302-631-8891
GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 11-SEP-06
BLDG. 500 MAIL BOX 514 510(k) SUMMARY AVAILABLE FROM FDA
P.O. BOX 6101, NEWARK, DE 19714-6101
DEVICE: DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEI
DADE BEHRING, INC. 510(k) NO: K061802(TRADITIONAL)
ATTN: KATHLEEN DRAY-LYONS PHONE NO : 781-826-4551
P.O. BOX 6101 SE DECISION MADE: 11-SEP-06
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATO
DADE BEHRING, INC. 510(k) NO: K061825(TRADITIONAL)
ATTN: KATHLEEN DRAY-LYONS PHONE NO : 781-826-4551
P.O. BOX 6101 SE DECISION MADE: 06-SEP-06
NEWARK,, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALI
DADE BEHRING, INC. 510(k) NO: K061852(TRADITIONAL)
ATTN: KATHLEEN DRAY-LYONS PHONE NO : 781-826-4551
P.O. BOX 6101 SE DECISION MADE: 22-SEP-06
NEWARK,, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 C
DADE BEHRING, INC. 510(k) NO: K061990(TRADITIONAL)
ATTN: KATHLEEN DRAY-LYONS PHONE NO : 781-826-4551
P.O. BOX 6101 SE DECISION MADE: 19-SEP-06
NEWARK,, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410)
DADE BEHRING, INC. 510(k) NO: K062034(TRADITIONAL)
ATTN: VICTOR M CARRIO PHONE NO : 302-631-0376
P.O. BOX 6101 SE DECISION MADE: 06-SEP-06
NEWARK, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC5
DADE BEHRING, INC. 510(k) NO: K062162(TRADITIONAL)
ATTN: VICTOR M CARRIO PHONE NO : 302-631-0376
P.O. BOX 6101 SE DECISION MADE: 14-SEP-06
NEWARK, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520
DADE BEHRING, INC. 510(k) NO: K062182(TRADITIONAL)
ATTN: VICTOR M CARRIO PHONE NO : 302-631-0376
500 GBC DR., M/S 514 SE DECISION MADE: 14-SEP-06
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714
DEVICE: DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)
DADE BEHRING, INC. 510(k) NO: K062199(TRADITIONAL)
ATTN: VICTOR M CARRIO PHONE NO : 302-631-0376
P.O. BOX 6101 SE DECISION MADE: 06-SEP-06
NEWARK, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN MICROSTREP PLUS PANEL VANCOMYCIN (0.06 - 8 MCG/ML)
DADE BEHRING, INC. 510(k) NO: K062290(TRADITIONAL)
ATTN: SHANNON POPSON PHONE NO : 916-374-3330
2040 ENTERPRISE BLVD. SE DECISION MADE: 01-SEP-06
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE
DADE BEHRING, INC. 510(k) NO: K062316(SPECIAL)
ATTN: LORRAINE H PIESTRAK PHONE NO : 302-631-6567
GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 06-SEP-06
BLDG. 500 MAIL BOX 514 510(k) SUMMARY AVAILABLE FROM FDA
P.O. BOX 6101, NEWARK, DE 19714-6101
DEVICE: DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130
DADE BEHRING, INC. 510(k) NO: K062334(TRADITIONAL)
ATTN: VICTOR M CARRIO PHONE NO : 302-631-0376
P.O. BOX BOX 6101, M/S 514 SE DECISION MADE: 22-SEP-06
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN MICROSTREP PLUS PANEL AZITHROMYCIN
DADE BEHRING, INC. 510(k) NO: K062585(TRADITIONAL)
ATTN: SHANNON POPSON PHONE NO : 916-374-3330
2040 ENTERPRISE BLVD. SE DECISION MADE: 19-SEP-06
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSTREP PLUS PANEL AMOXICILLIN/CLAVULANIC ACID
DADE BEHRING, INC. 510(k) NO: K062596(TRADITIONAL)
ATTN: SHANNON POPSON PHONE NO : 916-372-1900
2040 ENTERPRISE BLVD. SE DECISION MADE: 19-SEP-06
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMAX 9.5 STERILIZERS
DENTAL X SRL 510(k) NO: K052532(TRADITIONAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 919-859-4207
49 PLAIN STREET SE DECISION MADE: 05-SEP-06
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIRIT, MODEL M, U; DOCPORTMACRO, MODEL M, U, L
DENTALL CORP. 510(k) NO: K061658(TRADITIONAL)
ATTN: EDWIN FIRST PHONE NO : 949-587-0120
3 FARADAY #B SE DECISION MADE: 18-SEP-06
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K061648(TRADITIONAL)
ATTN: NANCY FRIDDLE PHONE NO : 574-371-4923
P.O. BOX 988 SE DECISION MADE: 11-SEP-06
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY SIGMA CRUCIATE RETAINING POROCOAT FEMORAL COMPONENTS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K062654(TRADITIONAL)
ATTN: NANCY FRIDDLE PHONE NO : 574-371-4923
700 ORTHOPAEDIC DR. SE DECISION MADE: 29-SEP-06
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SFX SNAP-FIT CROSS CONNECTOR
DEPUY SPINE, INC. 510(k) NO: K062196(TRADITIONAL)
ATTN: MARY GRAY PHONE NO : 508-828-3649
325 PARAMOUNT DR. SE DECISION MADE: 11-SEP-06
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALGICELL AG
DERMA SCIENCES CANADA, INC. 510(k) NO: K052536(TRADITIONAL)
ATTN: DELA SHARMINI ATHERAY PHONE NO : 416 299 4003 X245
104 SHORTING RD. SE DECISION MADE: 13-SEP-06
TORONTO, ONTARIO, CANADA M1S 3S4 510(k) STATEMENT
DEVICE: MODIFICATION TO DIADEXUS PLAC TEST
DIADEXUS, INC. 510(k) NO: K062234(SPECIAL)
ATTN: ROBERT L WOLFERT PHONE NO : 650-246-6430
343 OYSTER POINT BLVD. SE DECISION MADE: 11-SEP-06
SOUTH SAN FRANCISCO, CA 94080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION
DIALYSIS SERVICES, INC. 510(k) NO: K060333(TRADITIONAL)
ATTN: MIKE STERLING PHONE NO : 615-384-4810
130 ELDER DR. SE DECISION MADE: 08-SEP-06
SPRINGFIELD, TN 37172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SM IMPLANT SYSTEMS
DIO DEPARTMENT DSI, INC. 510(k) NO: K061797(TRADITIONAL)
ATTN: DAE KYU CHANG PHONE NO : 562-404-8466
13340 E. FIRESTONE BLVD SE DECISION MADE: 01-SEP-06
SUITE J 510(k) SUMMARY AVAILABLE FROM FDA
SANTA FE SPRINGS, CA 90670
DEVICE: OWL URF-3AP
DIROS TECHNOLOGY, INC. 510(k) NO: K062758(SPECIAL)
ATTN: GEORGE DARMOS PHONE NO : 905 415 3440
232 HOOD ROAD SE DECISION MADE: 27-SEP-06
MARKHAM, ONTARIO, CANADA L3R 3K8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONFIDENCE EX HIGH VISCOSITY BONE CEMENT
DISC-O-TECH MEDICAL TECHNOLOGIES, 510(k) NO: K062424(SPECIAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 14-SEP-06
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 154
DUKAL CORP. 510(k) NO: K061864(TRADITIONAL)
ATTN: PATRICK J LAMB PHONE NO : 656-631-3800
5 PLANT AVE SE DECISION MADE: 15-SEP-06
HAUPPAUGE, NY 11788 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSEAR BONE CONDUCTION HEARING AID
EAR TECHNOLOGY CORP. 510(k) NO: K062404(SPECIAL)
ATTN: RICK GILBERT PHONE NO : 423-928-9060
106 E WATAUGA AVE. SE DECISION MADE: 08-SEP-06
JOHNSON CITY, TN 37601 510(k) STATEMENT
DEVICE: MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MED
EDWARDS LIFESCIENCES RESEARCH MEDI510(k) NO: K062429(TRADITIONAL)
ATTN: KAREN JONES PHONE NO : 801-565-6156
6864 SOUTH 300 WEST SE DECISION MADE: 27-SEP-06
MIDVALE, UT 84047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBERLE SHAVER SYSTEM C2 AND SHAVER BLADES
EFS EBERLE FEINWERKTECHNISCHE SYST510(k) NO: K061134(TRADITIONAL)
ATTN: GERALD GOIGITZER PHONE NO : 954-217-8780
731-733 SHOTGUN ROAD SE DECISION MADE: 01-SEP-06
FT. LAUDERDALE, FL 33326 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOFAST RELIANT SYSTEM
ENDOGUN MEDICAL SYSTEMS 510(k) NO: K060329(TRADITIONAL)
ATTN: AMY AULWES PHONE NO : 781-329-2993
690 CANTON STREET, SUITE 302 SE DECISION MADE: 11-SEP-06
WESTWOOD, MA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPOC BLOOD ANALYSIS SYSTEM
EPOCAL, INC. 510(k) NO: K061597(TRADITIONAL)
ATTN: ROY LAYER PHONE NO : 613 738 6192
2935 CONROY ROAD SE DECISION MADE: 27-SEP-06
OTTAWA, CANADA K1G 6C6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014
EPS BIO TECHNOLOGY CORP. 510(k) NO: K061992(SPECIAL)
ATTN: Y C LEI PHONE NO : 886 357 52522X101
2 F,NO. 49-2, LANE 2, SEC. 2, SE DECISION MADE: 19-SEP-06
GUANG FU ROAD 510(k) SUMMARY AVAILABLE FROM FDA
HSINCHU CITY, CHINA (TAIWAN) 300
DEVICE: ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM
ETHICON ENDO-SURGERY, INC. 510(k) NO: K061770(TRADITIONAL)
ATTN: TOM BOSTICCO PHONE NO : 513-337-8935
4545 CREEK RD. SE DECISION MADE: 25-SEP-06
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CO
ETHICON ENDO-SURGERY, INC. 510(k) NO: K062000(TRADITIONAL)
ATTN: CAROL WALSH PHONE NO : 513-337-3792
4545 CREEK RD. SE DECISION MADE: 25-SEP-06
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.
EUROIMMUN US LLC 510(k) NO: K060700(TRADITIONAL)
ATTN: KATHRYN KOHL PHONE NO : 973-402-6101
TEK CAMPUS OF MORRIS COUNTY SE DECISION MADE: 08-SEP-06
429 ROCKAWAY VALLEY RD. U.1200 510(k) SUMMARY AVAILABLE FROM FDA
BOONTON TWP, NJ 07005
DEVICE: OPTECURE +CCC
EXACTECH, INC. 510(k) NO: K061668(TRADITIONAL)
ATTN: MARITZA ELIAS PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 12-SEP-06
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESE
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K060734(TRADITIONAL)
ATTN: JANET C KAY PHONE NO : 781-402-4475
95 HAYDEN AVE. SE DECISION MADE: 05-SEP-06
LEXINGTON, MA 02420 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM
GE HEALTHCARE 510(k) NO: K061741(TRADITIONAL)
ATTN: ALLEN TABOR PHONE NO : 414-721-3957
9900 INNOVATION DRIVE SE DECISION MADE: 15-SEP-06
RP-2125 510(k) SUMMARY AVAILABLE FROM FDA
WAUWATOSA, WI 53226
DEVICE: TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233; WITHOUT FO
GE HEALTHCARE 510(k) NO: K061942(TRADITIONAL)
ATTN: JOEL C KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 29-SEP-06
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE VANTAGE PET NEURO SOFTWARE
GE HEALTHCARE 510(k) NO: K062393(TRADITIONAL)
ATTN: D. DUERSTELER PHONE NO : 262-312-7029
3000 N. GRANDVIEW BLVD. SE DECISION MADE: 01-SEP-06
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AN
GE HEALTHCARE 510(k) NO: K062576(SPECIAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 29-SEP-06
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPSY DIGIT-AM
GIOTTO USA, LLC 510(k) NO: K062039(TRADITIONAL)
ATTN: ALLISON SCOTT PHONE NO : 317-569-9500
11460 N MERIDIAN ST., STE 150 SE DECISION MADE: 11-SEP-06
CARMEL, IN 46032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFIBRA, MODEL 1200
GLOBAL DENTAL PRODUCTS, INC. 510(k) NO: K061735(TRADITIONAL)
ATTN: JERRY BARTICK PHONE NO : 516-221-8844
1028 MCLEAN AVE SE DECISION MADE: 08-SEP-06
WANTAGH, NY 11793 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GATEWAY THORACOLUMBAR PLATE SYSTEM
GLOBUS MEDICAL, INC. 510(k) NO: K062407(SPECIAL)
ATTN: KELLY J BAKER PHONE NO : 610-415-9000
303 SCHELL LANE SE DECISION MADE: 06-SEP-06
PHOENIXVILLE, PA 19460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES
GRACE MEDICAL, INC. 510(k) NO: K062385(TRADITIONAL)
ATTN: JEFF COBB PHONE NO : 901-380-7000
8500 WOLF LAKE DR., STE. 110 SE DECISION MADE: 27-SEP-06
MEMPHIS, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGICAL HEADLIGHT
GULF MEDICAL FIBEROPTICS 510(k) NO: K061690(TRADITIONAL)
ATTN: MARCELINO AFANADOR PHONE NO : 813-891-1993
148 DUNBAR AVE., UNIT B SE DECISION MADE: 15-SEP-06
OLDSMAR, FL 34677 510(k) STATEMENT
DEVICE: BOSWORTH DENTIN RESIN
HARRY J. BOSWORTH CO. 510(k) NO: K061611(TRADITIONAL)
ATTN: MILDRED M GOLDSTEIN PHONE NO : 847-679-3400
7227 NORTH HAMLIN AVE. SE DECISION MADE: 11-SEP-06
SKOKIE, IL 60076 510(k) STATEMENT
DEVICE: LYRA ACUPUNCTURE NEEDLES
HELIO MEDICAL SUPPLIES, INC. 510(k) NO: K062448(TRADITIONAL)
ATTN: ERIC CHENG PHONE NO : 408-433-3355
606 CHARCOT AVE. SE DECISION MADE: 20-SEP-06
SAN JOSE, CA 95131 510(k) STATEMENT
DEVICE: HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201
HEMOCUE AB 510(k) NO: K060765(TRADITIONAL)
ATTN: ALLEN WHITE PHONE NO : 949-859-2630
40 EMPIRE DRIVE SE DECISION MADE: 06-SEP-06
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABX PENTRA 400 : CRP
HORIBA ABX 510(k) NO: K061138(TRADITIONAL)
ATTN: TIM LAWTON PHONE NO : 334 671 47320
PARC EUROMEDECINE SE DECISION MADE: 29-SEP-06
RUE DU CADUCEE 510(k) SUMMARY AVAILABLE FROM FDA
MONTPELLIER, HERAULT, FRANCE 34184
DEVICE: HOSPIRA ENTERAL FEEDING SET, MODEL 20640
HOSPIRA, INC. 510(k) NO: K061432(TRADITIONAL)
ATTN: DIANE RENNPFERD PHONE NO : 224-212-5452
275 N. FIELD DR., BLDG. H-2 SE DECISION MADE: 11-SEP-06
D-389 510(k) SUMMARY AVAILABLE FROM FDA
LAKE FOREST, IL 60045-5045
DEVICE: TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT
HOSPIRA, INC. 510(k) NO: K061573(SPECIAL)
ATTN: THOMAS KOZMA PHONE NO : 224-212-4803
275 NORTH FIELD DR. SE DECISION MADE: 19-SEP-06
LAKE FOREST, IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IQ-SYSTEM PACS SYSTEM
IMAGE INFORMATION SYSTEMS, LTD. 510(k) NO: K062488(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1600 MANCHESTER WAY SE DECISION MADE: 19-SEP-06
CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XPLORER 1590
IMAGING DYNAMICS COMPANY LTD. 510(k) NO: K062405(SPECIAL)
ATTN: SHIRANTHA SAMARAPPULI PHONE NO : 403 251 9939
151,2340 PEGASUS WAY, NE SE DECISION MADE: 13-SEP-06
CALGARY, ALBERTA, CANADA T2E 8M5 510(k) STATEMENT
DEVICE: XPLORER 1100
IMAGING DYNAMICS COMPANY LTD. 510(k) NO: K062417(SPECIAL)
ATTN: SHIRANTHA SAMARAPPULI PHONE NO : 403 251 9939
151,2340 PEGASUS WAY, NE SE DECISION MADE: 15-SEP-06
CALGARY, ALBERTA, CANADA T2E 8M5 510(k) STATEMENT
DEVICE: XPLORER 1600 PLUS
IMAGING DYNAMICS COMPANY LTD. 510(k) NO: K062586(SPECIAL)
ATTN: SHIRANTHA SAMARAPPULI PHONE NO : 403 251 9939
151,2340 PEGASUS WAY, NE SE DECISION MADE: 29-SEP-06
CALGARY, ALBERTA, CANADA T2E 8M5 510(k) STATEMENT
DEVICE: MODIFICATION TO MYALLERGY TEST
IMMUNETECH CORPORATION 510(k) NO: K061979(SPECIAL)
ATTN: NANCY BENSON PHONE NO : 650-470-7420
888 OAK GROVE, SUITE 4 SE DECISION MADE: 22-SEP-06
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECTRA SYSTEM
IMPLANT DIRECT LLC 510(k) NO: K061319(TRADITIONAL)
ATTN: LESLIE TERRY PHONE NO : 818-444-3300
27030 MALIBU HILLS RD. SE DECISION MADE: 29-SEP-06
CALABASAS HILLS, CA 91301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOSIL HOMOCYSTEINE AND CONTROLS
INSTRUMENTATION LABORATORY CO. 510(k) NO: K061598(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 22-SEP-06
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-O
INSTRUMENTATION LABORATORY CO. 510(k) NO: K061974(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 15-SEP-06
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOSIL PROTEIN C
INSTRUMENTATION LABORATORY CO. 510(k) NO: K062430(SPECIAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 01-SEP-06
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOSIL LIQUID ANTITHROMBIN
INSTRUMENTATION LABORATORY CO. 510(k) NO: K062431(SPECIAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 01-SEP-06
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS
INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K062599(SPECIAL)
ATTN: DARLENE M WELSH PHONE NO : 609-936-2307
311 ENTERPRISE DR. SE DECISION MADE: 27-SEP-06
PLAINSBORO, NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERMEDIC DIODE LASER FAMILY 810NM AND 980NM (AND THE DELIVERY
INTERMEDIC ARFRAN, S.A. 510(k) NO: K053540(TRADITIONAL)
ATTN: KLAUS SIVEC PHONE NO : 480-241-3795
9233 E. NEVILLE AVE. #1128 SE DECISION MADE: 06-SEP-06
MEZA, AZ 85212 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INVACARE'S TWILIGHT II NASAL MASKS
INVACARE CORP. 510(k) NO: K061874(TRADITIONAL)
ATTN: JANICE BROWNLEE PHONE NO : 440-329-6595
ONE INVACARE WAY SE DECISION MADE: 05-SEP-06
ELYRIA, OH 44036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASYSTAND EVOLV
INVACARE CORP. 510(k) NO: K062402(TRADITIONAL)
ATTN: RONALD CLINES PHONE NO : 440-326-3115
ONE INVACARE WAY SE DECISION MADE: 21-SEP-06
ELYRIA, OH 44035-4190 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOLTENO3
IOP, INC. 510(k) NO: K062252(TRADITIONAL)
ATTN: JASON MALECKA PHONE NO : 714-549-1185
3184 AIRWAY AVE., BLDG. B SE DECISION MADE: 27-SEP-06
COSTA MESA, CA 92626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTILINK SPRINT
IVOCLAR VIVADENT, INC. 510(k) NO: K061781(TRADITIONAL)
ATTN: DONNA MARIE HARTNETT PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 05-SEP-06
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: EXCEL BOND DC, MODEL 28-200100
J. MORITA USA, INC. 510(k) NO: K060882(TRADITIONAL)
ATTN: HOWARD ROWE PHONE NO : 949-465-1034
9 MASON SE DECISION MADE: 01-SEP-06
IRVINE, CA 92618 510(k) STATEMENT
DEVICE: FORMCORE DC, MODEL 28-700100
J. MORITA USA, INC. 510(k) NO: K061664(TRADITIONAL)
ATTN: TAKESHI INOUE PHONE NO : 949-465-1051
9 MASON SE DECISION MADE: 08-SEP-06
IRVINE, CA 92618 510(k) STATEMENT
DEVICE: NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700
JAWON MEDICAL CO., LTD. 510(k) NO: K062462(TRADITIONAL)
ATTN: W. H PARK PHONE NO : 82 53 8560993
13 LOT, 21 BLOCK, JIN-RYANG SE DECISION MADE: 29-SEP-06
INDUSTRIAL COMPLEX 510(k) SUMMARY AVAILABLE FROM FDA
KYUNG-SUN, KYUNG-BUK, REPUBLIC OF THIRD PARTY REVIEW
DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
JIANGSU JAYSUN GLOVE CO., LTD. 510(k) NO: K062522(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 10 82387441
RM 1606 BLDG 1, JIANXIANG YUAN SE DECISION MADE: 08-SEP-06
NO.209 BEI SI HUAN ZHONG RD. 510(k) SUMMARY AVAILABLE FROM FDA
BEIJING, CHINA 100083
DEVICE: MODIFICATION TO LUCAS
JOLIFE AB 510(k) NO: K062401(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813
555 13TH ST. NW SE DECISION MADE: 28-SEP-06
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KENSEY NASH BONE VOID FILLER
KENSEY NASH CORPORATION 510(k) NO: K060917(TRADITIONAL)
ATTN: JENNIFER J BOSLEY PHONE NO : 610-594-4582
735 PENNSYLVANIA DRIVE SE DECISION MADE: 22-SEP-06
EXTON, PA 19341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P7013
KERBEROS PROXIMAL SOLUTIONS, INC. 510(k) NO: K062275(SPECIAL)
ATTN: TOM MASON PHONE NO : 408-517-2522
10600 NORTH TANTAU AVE. SE DECISION MADE: 20-SEP-06
CUPERTINO, CA 95014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLS MARTIN STERNAL TALON
KLS-MARTIN L.P. 510(k) NO: K051165(TRADITIONAL)
ATTN: JENNIJER DAMATO PHONE NO : 904-641-7746
11239-1 ST. JOHN'S IND. PKWY. SE DECISION MADE: 07-SEP-06
SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32246
DEVICE: SONICWELD RX ENDOBROW FIXATION
KLS-MARTIN L.P. 510(k) NO: K061507(TRADITIONAL)
ATTN: JENNIFER DAMATO PHONE NO : 904-641-7746
11239 ST. JOHNS INDUSTRIAL SE DECISION MADE: 21-SEP-06
PARKWAY SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32246
DEVICE: KOWA NONMYD ALPHA-D
KOWA CO. LTD. 510(k) NO: K062356(SPECIAL)
ATTN: SATOHIKO TAKANASHI PHONE NO : 81 3 32797329
4-14, NIHONBASHI-HONCHO SE DECISION MADE: 27-SEP-06
3-CHOME 510(k) SUMMARY AVAILABLE FROM FDA
CHUO-KU, TOKYO, JAPAN 103-8433
DEVICE: CLEARFIL MAJESTY ESTHETIC
KURARAY MEDICAL INC. 510(k) NO: K061860(TRADITIONAL)
ATTN: KOJI NISHIDA PHONE NO : 212-986-2230
101 EAST 52ND STREET, 26TH FL. SE DECISION MADE: 18-SEP-06
NEW YORK, NY 10022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARFIL CERAMIC PRIMER
KURARAY MEDICAL INC. 510(k) NO: K061906(TRADITIONAL)
ATTN: KOJI NISHIDA PHONE NO : 212-986-2230
101 EAST 52ND STREET, 26TH FL. SE DECISION MADE: 28-SEP-06
NEW YORK, NY 10022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARFIL DC BOND
KURARAY MEDICAL INC. 510(k) NO: K062382(TRADITIONAL)
ATTN: KOJI NISHIDA PHONE NO : 212-986-2230
600 LEXINGTON AVENUE SE DECISION MADE: 27-SEP-06
26TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10022
DEVICE: CLEARFIL ESTHETIC CEMENT & DC BOND
KURARAY MEDICAL INC. 510(k) NO: K062410(TRADITIONAL)
ATTN: KOJI NISHIDA PHONE NO : 212-986-2230
600 LEXINGTON AVENUE SE DECISION MADE: 26-SEP-06
26TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10022
DEVICE: ACUMED LASER, MODEL 1000
LASER THERA, LLC 510(k) NO: K060153(TRADITIONAL)
ATTN: SHELLY HENRY PHONE NO : 888-502-9955
11108 ASHFORD DRIVE SE DECISION MADE: 29-SEP-06
YUKON, OK 73099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEICA MODEL FL800
LEICA MICROSYSTEMS, INC. 510(k) NO: K061871(TRADITIONAL)
ATTN: MAX STURGIS PHONE NO : 888-244-6173
2337 LUCKY JOHN DRIVE SE DECISION MADE: 20-SEP-06
PARK CITY, UT 84060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMOSUIT SYSTEM
LIFE RECOVERY SYSTEMS HD, LLC 510(k) NO: K061023(TRADITIONAL)
ATTN: PAUL A TENTHOREY PHONE NO : 267-228-9717
29 ANTHONY TERRACE SE DECISION MADE: 20-SEP-06
DURHAM, CT 06422 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PILOT POSTERIOR LUMBAR PLATING SYSTEM
LIFE SPINE 510(k) NO: K061364(TRADITIONAL)
ATTN: ERIN MALLOY PHONE NO : 847-884-6117
2400 HASSELL ROAD SE DECISION MADE: 05-SEP-06
SUITE 370 510(k) SUMMARY AVAILABLE FROM FDA
HOFFMAN ESTATES, IL 60195
DEVICE: LITETOUCH DENTAL LASER SYSTEM
LIGHT INSTRUMENT LTD 510(k) NO: K061966(TRADITIONAL)
ATTN: YORAM LEVY PHONE NO : 972 463 88837
SE DECISION MADE: 27-SEP-06
510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIB
LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K062242(TRADITIONAL)
ATTN: MARIE LIN PHONE NO : 408-732-3856
687 NORTH PASTORIA AVE. SE DECISION MADE: 29-SEP-06
SUNNYVALE, CA 94085-2917 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINI POWER CHAIR, MODEL MN 5000
LINE IND.(SHANGHAI) CO., LTD. 510(k) NO: K062483(TRADITIONAL)
ATTN: SID MATHUR PHONE NO : 516-482-9001
55 NORTHERN BLVD. SE DECISION MADE: 08-SEP-06
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021 THIRD PARTY REVIEW
DEVICE: URYXXON RELAX URINE ANALYZER
MACHEREY-NAGEL GMBH & CO., KG. 510(k) NO: K061742(SPECIAL)
ATTN: ARMOND WELCH PHONE NO : 301-838-3120
7361 CALHOUN PLACE, SUITE 500 SE DECISION MADE: 06-SEP-06
ROCKVILLE, MD 20855 510(k) STATEMENT
DEVICE: MAGSTIM 200-2
MAGSTIM COMPANY US, LLC. 510(k) NO: K060847(TRADITIONAL)
ATTN: REZA JALINOUS PHONE NO : 781-933-3933
304 CAMBRIDGE RD SE DECISION MADE: 26-SEP-06
SUITE 502 510(k) SUMMARY AVAILABLE FROM FDA
WOBURN, MA 01801
DEVICE: VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET,
MAINE STANDARDS CO. 510(k) NO: K062501(TRADITIONAL)
ATTN: HOLLY CRESSMAN PHONE NO : 207-892-1300
765 ROOSEVELT TRAIL SE DECISION MADE: 29-SEP-06
WINDHAM, ME 04062-5365 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGI-WRAP MAST BIORESORBABLE SHEET
MAST BIOSURGERY USA INC. 510(k) NO: K061473(TRADITIONAL)
ATTN: KENNETH K KLEINHENZ PHONE NO : 858-458-0900
6749 TOP GUN ST., SUITE C SE DECISION MADE: 21-SEP-06
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDIC4ALL TELEMEDICINE SYSTEM VMS-01
MEDIC4ALL (ISRAEL) LTD. 510(k) NO: K061502(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 15-SEP-06
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CTC WORKSTATION, MODEL 2200
MEDICAL DIAGNOSTIC TECHNOLOGIES, I510(k) NO: K062229(TRADITIONAL)
ATTN: JAMES M BENSON PHONE NO : 702-933-0771
8960 W TROPICANA AVE SE DECISION MADE: 11-SEP-06
SUITE 700 510(k) SUMMARY AVAILABLE FROM FDA
LAS VEGAS, NV 89147
DEVICE: MEDGRAPHICS ULTIMA SYSTEM
MEDICAL GRAPHICS CORP. 510(k) NO: K061731(SPECIAL)
ATTN: LYNN BROSIOUS PHONE NO : 651-766-3316
350 OAK GROVE PKWY. SE DECISION MADE: 06-SEP-06
ST. PAUL, MN 55127-8599 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IGUIDE SYSTEM
MEDICAL INTELLIGENCE MEDIZINTECHNI510(k) NO: K062611(TRADITIONAL)
ATTN: MICHAEL WOLFF PHONE NO : 49 823 2969235
FEYERABENDSTRASSE 13-15 SE DECISION MADE: 20-SEP-06
SCHWABMUNCHEN, GERMANY 86830 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO HEXAPOD RT COUCH TOP
MEDICAL INTELLIGENCE MEDIZINTECHNI510(k) NO: K062639(SPECIAL)
ATTN: MICHAEL WOLFF PHONE NO : 49 823 2969235
FEYERABENDSTRASSE 13-15 SE DECISION MADE: 21-SEP-06
SCHWABMUNCHEN, GERMANY 86830 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HIERSPEC SPECULUM
MEDICAL PRODUCTS DIV. 510(k) NO: K061339(TRADITIONAL)
ATTN: THOMAS W COPELAND PHONE NO : 317-241-2457
2410 EXECUTIVE DRIVE SE DECISION MADE: 19-SEP-06
INDIANAPOLIS, IN 46241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100
MEDICAL PRODUCTS MFG., LLC 510(k) NO: K062119(SPECIAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 22-SEP-06
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200
MEDLOGIC GLOBAL LTD. 510(k) NO: K052870(TRADITIONAL)
ATTN: TIERNEY NORSTED PHONE NO : 952-746-8080
5353 WAYZATA BLVD., SUITE 505 SE DECISION MADE: 29-SEP-06
MINNEAPOLIS, MN 55416 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC PS MEDICAL STRATA TYPE VALUE
MEDTRONIC NEUROSURGERY 510(k) NO: K060681(SPECIAL)
ATTN: JEFFREY HENDERSON PHONE NO : 805-968-1546
125 CREMONA DR. SE DECISION MADE: 15-SEP-06
GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIMESH SELF DRILLING SCREW
MEDTRONIC NEUROSURGERY 510(k) NO: K062348(SPECIAL)
ATTN: JEFFREY HENDERSON PHONE NO : 805-968-1546
125 CREMONA DR. SE DECISION MADE: 08-SEP-06
GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MSD BIPOLAR FORCEPS
MEDTRONIC SOFAMOR DANEK 510(k) NO: K061635(TRADITIONAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 05-SEP-06
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERTE-STACK SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K062427(TRADITIONAL)
ATTN: EDWARD CHIN PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 12-SEP-06
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K062606(SPECIAL)
ATTN: EDWARD S CHIN PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 25-SEP-06
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K061591(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 08-SEP-06
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VERTE-STACK SPINAL SYSTEM
MEDTRONIC SPINAL AND BIOLOGICS DIV510(k) NO: K062133(SPECIAL)
ATTN: LEE GRANT PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 26-SEP-06
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC EXPORT XT CATHETER
MEDTRONIC, INC. 510(k) NO: K061958(SPECIAL)
ATTN: KAREN A BROZOWSKI PHONE NO : 978-739-4143
37A CHERRY HILL DR. SE DECISION MADE: 05-SEP-06
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 5F SHERPA ACTIVE NX GUIDE CATHETER
MEDTRONIC, INC. 510(k) NO: K062420(SPECIAL)
ATTN: MARK PUOPOLO PHONE NO : 978-777-0042
37A CHERRY HILL DR. SE DECISION MADE: 08-SEP-06
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUSION
MEDWAVE, INC. 510(k) NO: K061557(TRADITIONAL)
ATTN: DONNA R LUNAK PHONE NO : 651-639-1227
4382 ROUND LAKE RD. WEST SE DECISION MADE: 15-SEP-06
ARDEN HILLS, MN 55112-3923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTEGRAL IMCROWN
MERZ DENTAL GMBH 510(k) NO: K061809(TRADITIONAL)
ATTN: RICHARD G HUNTER PHONE NO : 770-851-1827
4235 PROVIDENCE LN SE DECISION MADE: 13-SEP-06
TUCKER, GA 30084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MO
MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K061471(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 11-SEP-06
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAXTER DUPLOSPRAY MIS APPLICATOR
MICROMEDICS, INC. 510(k) NO: K061092(TRADITIONAL)
ATTN: THOMAS LOPAC PHONE NO : 651-452-1977
1270 EAGAN INDUSTRIAL ROAD SE DECISION MADE: 13-SEP-06
SUITE 120 510(k) STATEMENT
EAGAN, MN 55121
DEVICE: MIMVIEWER
MIMVISTA CORP. 510(k) NO: K062163(TRADITIONAL)
ATTN: PETER SIMMELINK PHONE NO : 216-896-9798
25200 CHAGRIN BLVD. SUITE 200 SE DECISION MADE: 22-SEP-06
CLEVELAND, OH 44122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIRNERGY+STREAM
NATURAL ENERGY SOLUTIONS AG 510(k) NO: K052492(TRADITIONAL)
ATTN: MARTINA GUNDEROTH PHONE NO : 498 714 308378
EISENHUTWEG 15 SE DECISION MADE: 05-SEP-06
KUMHAUSEN-PREISENBERG, GERMANY 840510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM
NEUSOFT MEDICAL SYSTEMS CO., LTD. 510(k) NO: K062451(TRADITIONAL)
ATTN: TIAN YANFANG PHONE NO : 86 24 83660649
NO.3-11, WENHUA ROAD SE DECISION MADE: 28-SEP-06
HEPING DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
SHENYANG, LIAONING, CHINA 110004 THIRD PARTY REVIEW
DEVICE: COOLTOUCH, MODEL CTEV
NEW STAR LASERS, INC. 510(k) NO: K061618(TRADITIONAL)
ATTN: DONALD V JOHNSON PHONE NO : 916-677-1900
9085 FOOTHILLS BLVD. SE DECISION MADE: 25-SEP-06
ROSEVILLE, CA 95747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOL TOUCH, MODELS CT3S, CTEV, NS160, CTEV, LC160
NEW STAR LASERS, INC. 510(k) NO: K062210(TRADITIONAL)
ATTN: DONALD V JOHNSON PHONE NO : 916-677-1900
9085 FOOTHILLS BLVD. SE DECISION MADE: 25-SEP-06
ROSEVILLE, CA 95747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AHMED GLAUCOMA VALVE, MODEL M4
NEW WORLD MEDICAL, INC. 510(k) NO: K060644(TRADITIONAL)
ATTN: A. MATEEN AHMED PHONE NO : 909-466-4304
10763 EDISON CT. SE DECISION MADE: 18-SEP-06
RANCHO CUCAMONGA, CA 91730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MP-1 MICROPERIMETER
NIDEK TECHNOLOGIES SRL 510(k) NO: K061768(TRADITIONAL)
ATTN: ALDO COCCHIGLIA PHONE NO : 39 049 8629200
VIA DELL ARTIGIANATO, 6/A SE DECISION MADE: 28-SEP-06
ALBIGNASEGO (PADOVA), ITALY 35020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFESOUND ESOPHAGEAL STETHOSCOPE
NOVAMED, LLC 510(k) NO: K062020(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
3460 POINTE CREEK CT. #102 SE DECISION MADE: 05-SEP-06
BONITA SPRINGS, FL 34134-2015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO NUVASIVE SPHERX II SYSTEM
NUVASIVE, INC. 510(k) NO: K062317(SPECIAL)
ATTN: LAETITIA COUSIN PHONE NO : 858-909-1868
4545 TOWNE CENTRE CT. SE DECISION MADE: 01-SEP-06
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARE-E-VAC 3
OHIO MEDICAL CORPORATION 510(k) NO: K062610(SPECIAL)
ATTN: HOBY CHAE PHONE NO : 847-855-6272
1111 LAKESIDE DR. SE DECISION MADE: 28-SEP-06
GURNEE, IL 60031 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVIS EXERA II 180 SYSTEM
OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K062049(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 484-896-5688
3500 CORPORATE PARKWAY SE DECISION MADE: 22-SEP-06
PO BOX 610 510(k) SUMMARY AVAILABLE FROM FDA
CENTER VALLEY, PA 18034-0610
DEVICE: OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM
OMNIGUIDE, INC. 510(k) NO: K062423(SPECIAL)
ATTN: DOUGLAS W WOODRUFF PHONE NO : 617-551-8404
ONE KENDALL SQUARE, BLDG 100 SE DECISION MADE: 21-SEP-06
3RD FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
CAMBRIDGE, MA 02139 THIRD PARTY REVIEW
DEVICE: ISS INTEGRATED SPINE SYSTEM
ORTHO DEVELOPMENT CORP. 510(k) NO: K061524(TRADITIONAL)
ATTN: WILLIAM J GRIFFIN PHONE NO : 801-619-3470
12187 SOUTH BUSINESS PARK DR. SE DECISION MADE: 26-SEP-06
DRAPER, UT 84020 510(k) STATEMENT
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALI
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K060770(TRADITIONAL)
ATTN: SARAH PARSONS PHONE NO : 585-453-3154
100 INDIGO CREEK DR. SE DECISION MADE: 15-SEP-06
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: ORLUS MINI SCREW
ORTHOLUTION CO., LTD. 510(k) NO: K052968(SPECIAL)
ATTN: CATHRYN CAMBRIA PHONE NO : 770-396-5909
5536 TROWBRIDGE DRIVE SE DECISION MADE: 08-SEP-06
ATLANTA, GA 30338 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PAJUNKS DISPOSABLE INSERTS FOR HANDLE INSTRUMENTS AND HF ELECTRO
PAJUNK GMBH MEDIZINTECHNOLOGIE 510(k) NO: K062072(SPECIAL)
ATTN: CHRISTIAN QUASS PHONE NO : 49 770 49291586
KARL-HALL-STRASSE 01 SE DECISION MADE: 22-SEP-06
GEISINGEN, BADEN-WURTTEMBERG, GERM510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMADAPT WOUND DRESSING
PEGASUS BIOLOGICS, INC. 510(k) NO: K061494(TRADITIONAL)
ATTN: PAMELA MISAJON PHONE NO : 949-502-3240
6 JENNER SE DECISION MADE: 21-SEP-06
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
IRVINE, CA 92618
DEVICE: LED PROLUX 770
PENG LIM ENTERPRISE CO., LTD. 510(k) NO: K061695(TRADITIONAL)
ATTN: C.S. WANG PHONE NO : 886 7 5872995
67 HWA RONG RD., 2ND FL., SE DECISION MADE: 14-SEP-06
KU SHAN DIST. 510(k) SUMMARY AVAILABLE FROM FDA
KAOHSIUNG, CHINA (TAIWAN)
DEVICE: EP NAVIGATOR SOFTWARE
PHILIPS MEDICAL SYSTEMS 510(k) NO: K062650(TRADITIONAL)
ATTN: LYNN HARMER PHONE NO : 425-487-7312
22100 BOTHELL EVERETT HWY SE DECISION MADE: 21-SEP-06
BOTHELL, WA 98041 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PULSERA
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K061685(TRADITIONAL)
ATTN: JOSEPH S ARNAUDO PHONE NO : 425-482-8958
22100 BOTHELL EVERETT HWY. SE DECISION MADE: 15-SEP-06
P.O. BOX 3003, MS 915 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98041-3003 THIRD PARTY REVIEW
DEVICE: XCELERA
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K061995(TRADITIONAL)
ATTN: LYNN T HARMER PHONE NO : 425-487-7312
22100 BOTHELL EVERETT HWY. SE DECISION MADE: 06-SEP-06
P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98041-3003 THIRD PARTY REVIEW
DEVICE: THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTEL
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K062283(SPECIAL)
ATTN: ANDREAS SUCHI PHONE NO : 497 031 4631291
HEWLETT-PACKARD-STR. 2 SE DECISION MADE: 20-SEP-06
BOEBLINGEN, GERMANY D-71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS MP5 INTELLIVUE PATIENT MONITOR
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K062392(SPECIAL)
ATTN: MARKUS STACHA PHONE NO : 49 703 14632840
HEWLETT-PACKARD STR.2 SE DECISION MADE: 06-SEP-06
BOEBLINGEN, GERMANY D 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ART LAB SOFTWARE
PIE MEDICAL 510(k) NO: K061961(TRADITIONAL)
ATTN: CARRI GRAHAM PHONE NO : 317-569-9500
11460 N. MERIDIAN ST. SE DECISION MADE: 06-SEP-06
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
CARMEL, IN 46032
DEVICE: PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM)
PLETHORA SOLUTIONS 510(k) NO: K062042(TRADITIONAL)
ATTN: KIMBERLEY DONEY PHONE NO : 781-860-0388
54 FOREST STREET SE DECISION MADE: 06-SEP-06
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD
PORTLAND ORTHOPAEDICS PTY. LTD. 510(k) NO: K061564(TRADITIONAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035
PO BOX 560 SE DECISION MADE: 01-SEP-06
STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FETCH ASPIRATION CATHETER
POSSIS MEDICAL, INC. 510(k) NO: K062172(TRADITIONAL)
ATTN: FRANK B FREEDMAN PHONE NO : 763-717-1013
9055 EVERGREEN BLVD., N.W. SE DECISION MADE: 20-SEP-06
COON RAPIDS, MN 55433-8003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHE
POWER MEDICAL INTERVENTIONS, INC. 510(k) NO: K061649(SPECIAL)
ATTN: BARBARA J WHITMAN PHONE NO : 267-775-4151
2021 CABOT BLVD. SE DECISION MADE: 01-SEP-06
LANGHORNE, PA 19047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREVU POINT OF CARE SKIN STEROL TEST
PREMD, INC. 510(k) NO: K062092(SPECIAL)
ATTN: THOMAS M TSAKERIS PHONE NO : 301-330-2076
16809 BRIARDALE ROAD SE DECISION MADE: 15-SEP-06
ROCKVILLE, MD 20855 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GO GO MINI, MODEL SC30
PRIDE MOBILITY PRODUCTS CORP. 510(k) NO: K062160(SPECIAL)
ATTN: THOMAS J SCHAPPERT PHONE NO : 570-655-5574
182 SUSQUEHANNA AVE. SE DECISION MADE: 12-SEP-06
EXETER, PA 18643 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLE
PROTEIN POLYMER TECHNOLOGIES, INC.510(k) NO: K061790(TRADITIONAL)
ATTN: RADINE POBUDA PHONE NO : 858-558-6064
10655 SORRENTO VALLEY RD. SE DECISION MADE: 19-SEP-06
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 201
QUIDEL CORP. 510(k) NO: K061008(TRADITIONAL)
ATTN: JOHN D TAMERIUS PHONE NO : 415-664-4904
10165 MCKELLAR CT. SE DECISION MADE: 08-SEP-06
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOSET XC
REGENERATION TECHNOLOGIES, INC. 510(k) NO: K060180(TRADITIONAL)
ATTN: LISA SIMPSON PHONE NO : 386-418-8888
11621 RESEARCH CIR. SE DECISION MADE: 06-SEP-06
P.O. BOX 2650 510(k) SUMMARY AVAILABLE FROM FDA
ALACHUA, FL 32616-2650
DEVICE: GENTLE COLON (REVISION 2.0)
RENDOSCOPY, INC. 510(k) NO: K061532(TRADITIONAL)
ATTN: MIRA PATTANAYAK PHONE NO : 631-586-2086
8 CROYDON COURT SE DECISION MADE: 18-SEP-06
DIX HILLS, NY 11746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VPAP MALIBU WITH H2I
RESMED LTD. 510(k) NO: K062291(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238
14040 DANIELSON ST. SE DECISION MADE: 08-SEP-06
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTICAL
RESPIRONICS, INC. 510(k) NO: K060919(TRADITIONAL)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120
1001 MURRY RIDGE LN. SE DECISION MADE: 22-SEP-06
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CYL-FIL OXYGEN SYSTEM
RESPONSIVE RESPIRATORY INC. 510(k) NO: K061785(TRADITIONAL)
ATTN: THOMAS BANNON PHONE NO : 636-600-4030
261 WOLFNER DRIVE SE DECISION MADE: 07-SEP-06
FENTON, MO 63026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTRAIT PSR3
RHYTEC INCORPORATED 510(k) NO: K060948(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245
5 TIMBER LANE SE DECISION MADE: 05-SEP-06
NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGI-LITE TCD DEVICE
RIMED LTD. 510(k) NO: K062578(SPECIAL)
ATTN: AHAVA STEIN PHONE NO : 972 976 700002
20 HATA'AS ST SE DECISION MADE: 18-SEP-06
KFAR SABA, ISRAEL 44425 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAPDOC I
ROBODENT GMBH 510(k) NO: K061224(TRADITIONAL)
ATTN: JUERGEN BIER PHONE NO : 49 30 49500820
KURFURSTENDAMM 213 SE DECISION MADE: 05-SEP-06
BERLIN, GERMANY 10719 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLUCOSE HK NEW FORMULATION TEST SYSTEM
ROCHE DIAGNOSTICS CORP. 510(k) NO: K062239(SPECIAL)
ATTN: THERESA AMBROSE BUSH PHONE NO : 317-521-3723
9115 HAGUE RD. SE DECISION MADE: 11-SEP-06
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360
ROCHE DIAGNOSTICS CORP. 510(k) NO: K062319(TRADITIONAL)
ATTN: CORINA HARPER PHONE NO : 317-521-3831
9115 HAGUE RD SE DECISION MADE: 13-SEP-06
P.O. BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0457
DEVICE: TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR W
ROZINN ELECTRONICS, INC. 510(k) NO: K061780(TRADITIONAL)
ATTN: MARK ROSOFF PHONE NO : 718-386-5526
71-22 MYRTLE AVE. SE DECISION MADE: 15-SEP-06
GLENDALE, NY 11385 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER S
RTC INC.-MEMCATH TECHNOLOGIES LLC 510(k) NO: K061663(TRADITIONAL)
ATTN: MARC JAKER PHONE NO : 651-450-7400
1777 OAKDALE AVE., SE DECISION MADE: 06-SEP-06
WEST ST. PAUL, MN 55118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DLM112 DAYLINK MONITOR
RTX HEALTHCARE A/S 510(k) NO: K062304(TRADITIONAL)
ATTN: BJARNE FLOU PHONE NO : 45 963 22300
STROEMMEN 6 SE DECISION MADE: 29-SEP-06
NOERRESUNDBY, DENMARK DK-9400 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SEDECAL X PLUS LP PLUS
SEDECAL S.A. 510(k) NO: K062335(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 14-SEP-06
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT
SENTRA MEDICAL DEVICES, LLC 510(k) NO: K062342(TRADITIONAL)
ATTN: KARTHIK MARAYAN PHONE NO : 734-502-9729
2831 WOODMONT DRIVE W SE DECISION MADE: 25-SEP-06
CANTON, MI 48188 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ARCHITECT CORTISOL ASSAY
SERADYN INC. 510(k) NO: K062204(TRADITIONAL)
ATTN: EARL E KNIGHT PHONE NO : 317-554-0639
7998 GEORGETOWN RD. SE DECISION MADE: 22-SEP-06
SUITE 1000 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46268-5260
DEVICE: INFANT HEEL WARMER BY INTCO
SHANGHAI INTCO MEDICAL SUPPLY CO.,510(k) NO: K053254(TRADITIONAL)
ATTN: JOHN ZHAO PHONE NO : 909-548-4828
12390 EAST END AVENUE SE DECISION MADE: 19-SEP-06
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEXTURED POWER FREE BP2000 (BUTADIENE POLYMER) EXAM GLOVES, NATU
SHEN WEI (USA), INC. 510(k) NO: K062067(TRADITIONAL)
ATTN: CYNTHIA LIU PHONE NO : 510-429-8692
33278 CENTRAL AVE., SE DECISION MADE: 06-SEP-06
SUITE 102 510(k) STATEMENT
UNION CITY, CA 94587
DEVICE: PULSE OXIMETER, MODEL PM-50
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K061442(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 05-SEP-06
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG JUNFEI PLASTIC PRODUC510(k) NO: K062655(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-548-7888
3973 SCHAEFER AVE SE DECISION MADE: 18-SEP-06
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SYNGO INSPACE 4D
SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K062673(SPECIAL)
ATTN: RUDIGER KOMER PHONE NO : 49 919 1189355
SIEMENSSTRASSE 1 SE DECISION MADE: 22-SEP-06
FORCHHEIM, GERMANY 91301 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: OVALTWIST PEDICLE SCREW SYSTEM
SIGNUS MEDIZINTECHNIK GMBH 510(k) NO: K061577(TRADITIONAL)
ATTN: MIKE ENSIGN PHONE NO : 801-467-7942
681 WEST 2760 NORTH SE DECISION MADE: 14-SEP-06
PLEASANT GROVE, UT 84062 510(k) STATEMENT
DEVICE: INCORIS AL
SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K062506(TRADITIONAL)
ATTN: FRITZ KOLLE PHONE NO : 49 625 1163294
FABRIKSTRASSE 31 SE DECISION MADE: 08-SEP-06
BENSHEIM, GERMANY D-64625 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: INCORIS ZI
SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K062509(TRADITIONAL)
ATTN: FRITZ KOLLE PHONE NO : 49 625 1163294
FABRIKSTRASSE 31 SE DECISION MADE: 12-SEP-06
BENSHEIM, GERMANY D-64625 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
SMITH & NEPHEW, INC. 510(k) NO: K062216(TRADITIONAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487
1450 BROOKS RD. SE DECISION MADE: 15-SEP-06
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD
SMITH & NEPHEW, INC. 510(k) NO: K062408(SPECIAL)
ATTN: GINO ROUSS PHONE NO : 901-399-6707
1450 BROOKS RD. SE DECISION MADE: 12-SEP-06
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO STOCKERT S5 SYSTEM
SORIN GROUP DEUTSCHLAND GMBH 510(k) NO: K062396(SPECIAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 28-SEP-06
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MCARE 300 VITAL SIGNS MONITOR, MODEL 91220
SPACELABS MEDICAL INC. 510(k) NO: K062095(ABBREVIATED)
ATTN: DAVID J GERAGHTY PHONE NO : 425-657-7200
5150 220TH AVE SE SE DECISION MADE: 29-SEP-06
PO BOX 7018 510(k) SUMMARY AVAILABLE FROM FDA
ISSAQUAH, WA, WA 98027-7018
DEVICE: SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847
SPACELABS MEDICAL INC. 510(k) NO: K062278(SPECIAL)
ATTN: DAVID J GERAGHTY PHONE NO : 425-657-7200
5150 220TH AVE SE SE DECISION MADE: 19-SEP-06
PO BOX 7018 510(k) SUMMARY AVAILABLE FROM FDA
ISSAQUAH, WA 98027-7018
DEVICE: CLIRPATH TURBO PERIPHERAL CATHETERS
SPECTRANETICS CORP. 510(k) NO: K060012(TRADITIONAL)
ATTN: MICHAEL J RYAN PHONE NO : 719-442-2433
96 TALAMINE CT. SE DECISION MADE: 29-SEP-06
COLORADO SPRINGS, CO 80907-5159 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROMETEY, MODEL G1-03
SPECTRUM INTERNATIONAL 510(k) NO: K062071(TRADITIONAL)
ATTN: GEORGE I BEKOV PHONE NO : 925-768-1122
2643 PLEASANT HILL ROAD SE DECISION MADE: 28-SEP-06
PLEASANT HILL, CA 94523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECTRUM M2 MONITOR
SPECTRUM MEDICAL, LLP 510(k) NO: K062468(TRADITIONAL)
ATTN: STEVE TURNER PHONE NO : 440 124 2229231
27 BATH ROAD SE DECISION MADE: 13-SEP-06
CHELTENHAM, UNITED KINGDOM GL53 7T510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS
SPIRE BIOMEDICAL, INC. 510(k) NO: K060288(TRADITIONAL)
ATTN: DONALD FICKETT PHONE NO : 781-275-6001
ONE PATRIOTS PARK SE DECISION MADE: 01-SEP-06
BEDFORD, MA 01730-2396 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROXIS SYSTEM, MODEL EPS101
ST. JUDE MEDICAL 510(k) NO: K060651(TRADITIONAL)
ATTN: KIMBERLY BRIGGS PHONE NO : 763-463-4700
6550 WEDGWOOD RD. NORTH SE DECISION MADE: 13-SEP-06
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
MAPLE GROVE, MN 55311
DEVICE: STRYKER INJECTABLE CEMENT
STRYKER 510(k) NO: K060763(TRADITIONAL)
ATTN: WADE T RUTKOSKIE PHONE NO : 877-534-2464
750 TRADE CENTER WAY SE DECISION MADE: 22-SEP-06
STE 200 510(k) SUMMARY AVAILABLE FROM FDA
KALAMAZOO, MI 49002
DEVICE: STRYKER DISPOSABLE LAPAROSCOPIC SCISSORS
STRYKER CORP. 510(k) NO: K061225(TRADITIONAL)
ATTN: DESIREE MAE CRISOLO PHONE NO : 408-754-2784
5900 OPTICAL COURT SE DECISION MADE: 14-SEP-06
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER URETERAL ILLUMINATION SYSTEM IV
STRYKER CORP. 510(k) NO: K061548(TRADITIONAL)
ATTN: ERICA A WALTERS PHONE NO : 408-754-2078
5900 OPTICAL COURT SE DECISION MADE: 28-SEP-06
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER SILVERGLIDE BIPOLAR FORCEPS REUSABLE CABLE; DISPOSABLE C
STRYKER INSTRUMENTS 510(k) NO: K061835(TRADITIONAL)
ATTN: JEAN W SHEPPARD PHONE NO : 269-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 08-SEP-06
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MANTIS SPINAL SYSTEM
STRYKER SPINE 510(k) NO: K061813(TRADITIONAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145
2 PEARL COURT SE DECISION MADE: 19-SEP-06
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICKIE RHAPSODY, MWD SERIES II POWER WHEELCHAIR
SUNRISE MEDICAL, INC. 510(k) NO: K062701(SPECIAL)
ATTN: JOSEPH E OLSAVSKY PHONE NO : 814-443-7690
7477 EAST DRY CREEK PKWY. SE DECISION MADE: 25-SEP-06
LONGMONT, CO 80503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPERDIMENSION/BRONCHUS PREMIUM 2
SUPERDIMENSION, LTD. 510(k) NO: K062315(SPECIAL)
ATTN: GEORGE MYERS PHONE NO : 201-737-1703
377 ROUTE 17 S SE DECISION MADE: 08-SEP-06
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) [SYNTHES] ANGULAR STABLE LOCKING SYSTEM (ASLS)
SYNTHES (USA) 510(k) NO: K061910(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-719-6940
1301 GOSHEN PKWY SE DECISION MADE: 21-SEP-06
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES LCP ANKLE ARTHRODESIS PLATES
SYNTHES (USA) 510(k) NO: K061940(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-719-6940
1301 GOSHEN PKWY SE DECISION MADE: 08-SEP-06
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES 3.5MM SPRING PLATE
SYNTHES (USA) 510(k) NO: K061973(TRADITIONAL)
ATTN: DEBORAH L JACKSON PHONE NO : 610-719-6500
1301 GOSHEN PKWY SE DECISION MADE: 11-SEP-06
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES OC FUSION SYSTEM
SYNTHES SPINE CO.LP 510(k) NO: K053418(TRADITIONAL)
ATTN: SUSAN LEWANDOWSKI PHONE NO : 610-719-5733
1302 WRIGHTS LANE EAST SE DECISION MADE: 06-SEP-06
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASY CHECK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM; CLEVER CHECK
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K062235(TRADITIONAL)
ATTN: PI-SHIOU LI PHONE NO : 886 2 6635-8080
4F, 88, SEC.1, KWANG FU ROAD SE DECISION MADE: 19-SEP-06
SAN CHUNG, TAIPEI, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
TANGSHAN LUXIONG PLASTIC PRODUCTS 510(k) NO: K061659(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 10 82387441
NO. 209 BEI SI HUAN ZHONG ROAD SE DECISION MADE: 15-SEP-06
HAIDIAN DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
BEIJING, CHINA 100083
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED
TANGSHAN LUXIONG PLASTIC PRODUCTS 510(k) NO: K061662(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 10 82387441
NO. 209 BEI SI HUAN ZHONG ROAD SE DECISION MADE: 15-SEP-06
HAIDIAN DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
BEIJING, CHINA 100083
DEVICE: MAXIFLEX-SEMI FLEX SCOPE
TECHNOLOGY DELIVERY SYSTEMS, INC. 510(k) NO: K062725(TRADITIONAL)
ATTN: CAROLANN KOTULA PHONE NO : 516-482-9001
55 NORTHERN BLVD. SE DECISION MADE: 29-SEP-06
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: KIT MENDEC SPINE AND DELIVERY SYSTEM
TECRES SPA 510(k) NO: K062452(SPECIAL)
ATTN: CHRISTINE BRAUER PHONE NO : 301-545-1990
1700 RESEARCH BOULEVARD SE DECISION MADE: 21-SEP-06
SUITE 220 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20850
DEVICE: 29G AND 30G K-PACK II NEEDLE
TERUMO EUROPE N.V. 510(k) NO: K062608(SPECIAL)
ATTN: M.J. AERTS PHONE NO : 32 16 381211
INTERLEUVENLAAN 40 SE DECISION MADE: 15-SEP-06
RESEARCHPARK ZONE 2 510(k) SUMMARY AVAILABLE FROM FDA
LEUVEN, BELGIUM 3001
DEVICE: ANTI-SNORING / SLEEP APNEA DEVICE
TOMED DR. TOUSSAINT GMBH 510(k) NO: K061688(TRADITIONAL)
ATTN: WINFRIED TOUSSAINT PHONE NO : 49 625 1983344
LINDBERGHSTR. 3A SE DECISION MADE: 08-SEP-06
BENSHEIM, GERMANY D-64625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TORNIER CEMENT RESTRICTOR
TORNIER 510(k) NO: K061824(TRADITIONAL)
ATTN: MIREILLE LEMERY PHONE NO : 33 476 613898
161 RUE LAVOISIER SE DECISION MADE: 14-SEP-06
MONTBONNOT 510(k) SUMMARY AVAILABLE FROM FDA
SAINT-ISMIER CEDEX, FRANCE 38334
DEVICE: CKIS-004A INJECTOR SYNCHRONIZATION OPTION
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K061976(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 27-SEP-06
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K062022(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-871-8909
982 KEYNOTE CIRCLE SUITE 6 SE DECISION MADE: 11-SEP-06
CLEVELAND, OH 44131 510(k) STATEMENT
DEVICE: DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS
TRIAGE MEDICAL, INC. 510(k) NO: K062391(TRADITIONAL)
ATTN: GAYLE HIROTA PHONE NO : 949-472-0006
13700 ALTON PKWY., SUITE 160 SE DECISION MADE: 14-SEP-06
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS
TRIPATH IMAGING, INC. 510(k) NO: K062428(TRADITIONAL)
ATTN: BRYAN J TUCKER PHONE NO : 919-206-7166
4025 STIRRUP CREEK DRIVE SE DECISION MADE: 29-SEP-06
STE. 400 510(k) STATEMENT
DURHAM, NC 27703
DEVICE: TYTAN BLOOD PRESSURE CUFF
TYTAN MEDICAL CORP. 510(k) NO: K062238(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO 58, FU-CHIUN ST. SE DECISION MADE: 21-SEP-06
HSIN-CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE
UNITED STATES SURGICAL, A DIVISION510(k) NO: K062326(SPECIAL)
ATTN: DANIEL CAMPION PHONE NO : 203-492-6339
150 GLOVER AVE. SE DECISION MADE: 01-SEP-06
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRILOGY TX WITH 3RD PARTY COUCH TOP SUPPORT
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K062618(SPECIAL)
ATTN: VY TRAN PHONE NO : 650-424-5731
3100 HANSEN WAY SE DECISION MADE: 22-SEP-06
PALO ALTO, CA 94304 510(k) STATEMENT
DEVICE: PROXIS SYSTEM
VELOCIMED INC. 510(k) NO: K052523(TRADITIONAL)
ATTN: KIMBERLY BRIGGS PHONE NO : 763-463-5713
6550 WEDGWOOD RD. NORTH SE DECISION MADE: 07-SEP-06
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55311
DEVICE: AVEA VENTILATOR
VIASYS RESPIRATORY CARE INC 510(k) NO: K062093(SPECIAL)
ATTN: TOM GUTIERREZ PHONE NO : 760-778-7255
1100 BIRD CENTER DR. SE DECISION MADE: 20-SEP-06
PALM SPRINGS, CA 92262 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOYAGER PACS SYSTEM
VOYAGER IMAGING 510(k) NO: K062062(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1600 MANCHESTER WAY SE DECISION MADE: 11-SEP-06
CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUTRISAFE 2
VYGON CORP. 510(k) NO: K060944(SPECIAL)
ATTN: COURTNEY SMITH PHONE NO : 610-539-9300
2495 GENERAL ARMISTEAD AVE SE DECISION MADE: 15-SEP-06
NORRISTOWN, PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTICATH EXPERT
VYGON CORP. 510(k) NO: K061250(TRADITIONAL)
ATTN: COURTNEY SMITH PHONE NO : 610-539-9300
2495 GENERAL ARMISTEAD AVE SE DECISION MADE: 29-SEP-06
NORRISTOWN, PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFECATH S PICC AND MIDLINE CATHETER
VYGON CORP. 510(k) NO: K062425(SPECIAL)
ATTN: COURTNEY SMITH PHONE NO : 610-539-9300
2495 GENERAL ARMISTEAD AVE SE DECISION MADE: 15-SEP-06
NORRISTOWN, PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS
VYGON US LLC 510(k) NO: K052475(SPECIAL)
ATTN: COURTNEY SMITH PHONE NO : 610-539-9300
2495 GENERAL ARMSTEAD AVE. SE DECISION MADE: 14-SEP-06
NORRISTOWN, PA 19403 510(k) STATEMENT
DEVICE: GLADIATOR BIPOLAR SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K062693(SPECIAL)
ATTN: MATT PAUL PHONE NO : 901-867-4350
5677 AIRLINE RD. SE DECISION MADE: 29-SEP-06
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OCCULTECH FECAL OCCULT BLOOD RAPID TEST
YD DIAGNOSTICS CORP. 510(k) NO: K060953(TRADITIONAL)
ATTN: DUSIC KWAK PHONE NO : 703-658-6347
4304 EVERGREEN LANE SE DECISION MADE: 18-SEP-06
SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA
ANNANDALE, VA 22003
DEVICE: SCREW-VENT IMPLANT SYSTEM, SV;TAPERED SCREW -VENT IMPLANT SYSTEM
ZIMMER DENTAL INC. 510(k) NO: K061410(TRADITIONAL)
ATTN: FLOYD LARSON PHONE NO : 858-792-1235
11234 EL CAMINO REAL, SE DECISION MADE: 08-SEP-06
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92130
DEVICE: ZIMMER ONE-PIECE IMPLANT, 3.7 MM, ANGLED
ZIMMER DENTAL INC. 510(k) NO: K061717(TRADITIONAL)
ATTN: ERIN MCVEY PHONE NO : 760-929-4300
1900 ASTON AVE. SE DECISION MADE: 08-SEP-06
CARLSBAD, CA 92008-7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER ONE-PIECE IMPLANT, 4.7MM, STRAIGHT, MODELS ZOP47S10, ZOP4
ZIMMER DENTAL INC. 510(k) NO: K062281(SPECIAL)
ATTN: ERIN L MCVEY PHONE NO : 760-929-4166
1900 ASTON AVE. SE DECISION MADE: 05-SEP-06
CARLSBAD, CA 92008-7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM
ZIMMER TRABECULAR 510(k) NO: K061155(TRADITIONAL)
ATTN: ROBERT A POGGIE PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 22-SEP-06
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIRKONZAHN ICE
ZIRKONZAHN GMBH 510(k) NO: K061851(TRADITIONAL)
ATTN: DONNA M HARTNETT PHONE NO : 716-934-3395
67 MAIN STREET SE DECISION MADE: 29-SEP-06
SILVER CREEK, NY 14136 510(k) STATEMENT
TOTAL 510(k)s THIS PERIOD 283
TOTAL WITH SUMMARIES 256
TOTAL WITH STATEMENTS 27
Updated October 5, 2006
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