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Medical Devices
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November 2006 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-NOV-2006 THROUGH 30-NOV-2006
DEVICE: LAVA SOFTWARE
3M ESPE AG DENTAL PRODUCTS 510(k) NO: K062493(TRADITIONAL)
ATTN: SABINE KRISCHER PHONE NO : 011 498 1527001238
ESPE PLATZ SE DECISION MADE: 17-NOV-06
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALCIUM
ABBOTT LABORATORIES 510(k) NO: K062855(TRADITIONAL)
ATTN: LINDA MORRIS PHONE NO : 972-518-6711
1921 HURD DR. SE DECISION MADE: 22-NOV-06
IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SILVER ALGINATE II WOUND DRESSING
ADVANCED MEDICAL SOLUTIONS LIMITED510(k) NO: K063173(SPECIAL)
ATTN: GRAHAME SOMERVILLE PHONE NO : 440 160 6863500
ROAD THREE SE DECISION MADE: 03-NOV-06
WINSFORD INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA
WINSFORD, CHESHIRE, UNITED KINGDOM CW7 3PD
DEVICE: ART SHIELDED BREAST APPLICATOR
ADVANCED RADIATION THERAPY, LLC 510(k) NO: K062135(TRADITIONAL)
ATTN: RAYMOND J BRICAULT PHONE NO : 978-663-7300
9 LINNELL CIRCLE SE DECISION MADE: 07-NOV-06
BILLERICA, MA 01820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AESCULAP STERILCONTAINER SYSTEM
AESCULAP 510(k) NO: K062510(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 610-984-9072
3773 CORPORATE PKWY. SE DECISION MADE: 17-NOV-06
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AESCULAP PNEUMATIC KERRISON
AESCULAP, INC. 510(k) NO: K062413(TRADITIONAL)
ATTN: KATHY A RACOSKY PHONE NO : 610-797-9300
3773 CORPORATE PKWY. SE DECISION MADE: 21-NOV-06
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD
AESCULAP, INC. 510(k) NO: K062684(SPECIAL)
ATTN: KATHY A RACOSKY PHONE NO : 610-984-9291
3773 CORPORATE PKWY. SE DECISION MADE: 22-NOV-06
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528
AGAMATRIX 510(k) NO: K062434(SPECIAL)
ATTN: CONNIE HERTEL PHONE NO : 603-328-6000
10 MANOR PARKWAY SE DECISION MADE: 13-NOV-06
SALEM, NH 03079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DX-SI
AGFA CORP. 510(k) NO: K063421(TRADITIONAL)
ATTN: JEFFERY A JEDLICKA PHONE NO : 864-421-1815
10 SOUTH ACADEMY ST. SE DECISION MADE: 22-NOV-06
GREENVILLE, SC 29601 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
ALCON RESEARCH, LTD. 510(k) NO: K062930(ABBREVIATED)
ATTN: JANET G JOHNSON PHONE NO : 407-513-8954
2501 DISCOVERY DR. SE DECISION MADE: 08-NOV-06
SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA
ORLANDO, FL 32826
DEVICE: SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S
ANACAPA TECHNOLOGIES, INC. 510(k) NO: K062212(TRADITIONAL)
ATTN: ILA DOSHI PHONE NO : 909-394-7795
301 E. ARROW HWY SE DECISION MADE: 21-NOV-06
STE. 106 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIMAS, CA 91773
DEVICE: ARTHREX INTERFERENCE SCREW
ARTHREX, INC. 510(k) NO: K062466(TRADITIONAL)
ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 29-NOV-06
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAHI PRECIOUS GUIDE CATHETER
ASAHI INTECC CO., LTD. 510(k) NO: K061601(TRADITIONAL)
ATTN: YOSHI TERAI PHONE NO : 949-756-8252
1301 DOVE STREET, SUITE #350 SE DECISION MADE: 17-NOV-06
NEWPORT BEACH, CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAHI PTCA GUIDE WIRE, FIELDER J, MODEL AGP140000J, AGP140300J
ASAHI INTECC CO., LTD. 510(k) NO: K062186(SPECIAL)
ATTN: YOSHI TERAI PHONE NO : 949-756-8252
1301 DOVE STREET, SUITE #350 SE DECISION MADE: 09-NOV-06
NEWPORT BEACH, CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KI
AXIS-SHIELD DIAGNOSTICS, LTD. 510(k) NO: K062467(TRADITIONAL)
ATTN: ERICA CONWAY PHONE NO : 441 382 4X22000
THE TECHNOLOGY PARK SE DECISION MADE: 22-NOV-06
DUNDEE, SCOTLAND, UNITED KINGDOM D510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WOR
AXON SYSTEMS, INC. 510(k) NO: K061639(TRADITIONAL)
ATTN: HOWARD BAILIN PHONE NO : 631-436-5112
400-2200 OSER AVE. SE DECISION MADE: 01-NOV-06
HAUPPAUGE, NY 11788 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INJEKT SYRINGE
B. BRAUN MEDICAL, INC. 510(k) NO: K063280(TRADITIONAL)
ATTN: CHRISTINE FORD PHONE NO : 610-596-2367
901 MARCON BLVD. SE DECISION MADE: 17-NOV-06
ALLENTOWN, PA 18109-9341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHETIC VINYL PATIENT EXAM GLOVES POWDER-FREE, YELLOW
BAODING GUANZHONG GLOVE CO., LTD. 510(k) NO: K062715(TRADITIONAL)
ATTN: MARY A DOUCETTE PHONE NO : 760-318-4973
10 SETON COURT SE DECISION MADE: 03-NOV-06
RANCHO MIRAGE, CA 92270 510(k) STATEMENT
DEVICE: NIO 5MP-M-21" (NIO 5MP MAMMO); MDNG-5121 BB
BARCOVIEW 510(k) NO: K062131(TRADITIONAL)
ATTN: LIEVEN DE WANDEL PHONE NO : 325 623 3459
35 PRESIDENT KENNEDYPARK SE DECISION MADE: 17-NOV-06
KORTRIJK, BELGIUM B-8500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARRX HALO COAGULATION SYSTEM; GENERATOR, MODEL 90-9000; OUTPUT
BARRX MEDICAL, INCORPORATED 510(k) NO: K062441(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 14-NOV-06
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HALO90 COAGULATION CATHETER
BARRX MEDICAL, INCORPORATED 510(k) NO: K062723(SPECIAL)
ATTN: VIORICA FILIMON PHONE NO : 408-328-7302
540 OAKMEAD PARKWAY SE DECISION MADE: 09-NOV-06
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM
BAYER HEALTHCARE, LLC 510(k) NO: K062347(TRADITIONAL)
ATTN: MARC HENN PHONE NO : 574-262-7719
430 SOUTH BEIGER ST. SE DECISION MADE: 22-NOV-06
MISHAWAKA, IN 46544 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (GN) 0.5-
BECTON, DICKINSON & CO. 510(k) NO: K062944(TRADITIONAL)
ATTN: JANINE MATLAK PHONE NO : 410-316-4938
7 LOVETON CIR. SE DECISION MADE: 15-NOV-06
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERTAPENEM (GN) 0.25-3
BECTON, DICKINSON & CO. 510(k) NO: K062945(TRADITIONAL)
ATTN: VICKI L KENNEDY PHONE NO : 410-316-4161
7 LOVETON CIR. SE DECISION MADE: 21-NOV-06
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE 5.0 X 6.0MM DENTAL IMPLANT
BICON, INC. 510(k) NO: K062044(TRADITIONAL)
ATTN: VINCENT J MORGAN PHONE NO : 617-390-0010
501 ARBORWAY SE DECISION MADE: 21-NOV-06
BOSTON, MA 02130 510(k) STATEMENT
DEVICE: BINAXNOW INFLUENZA A & B TEST
BINAX, INC. 510(k) NO: K062109(TRADITIONAL)
ATTN: ANGELA DRYSDALE PHONE NO : 207-730-5700
10 SOUTHGATE RD. SE DECISION MADE: 09-NOV-06
SCARBOROUGH, ME 04074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOHORIZONS CERAMIC ABUTMENT
BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K061567(TRADITIONAL)
ATTN: WINSTON GREER PHONE NO : 205-967-7880
ONE PERIMETER PARK SOUTH SE DECISION MADE: 22-NOV-06
SUITE 230, SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
BIRMINGHAM, AL 35243
DEVICE: FIDIS TM THYRO, MODEL MX002
BIOMEDICAL DIAGNOSTICS (BMD) SA 510(k) NO: K061794(TRADITIONAL)
ATTN: CHRISTELLE COURIVAUD PHONE NO : 404-248-0002
ACTIPOLE 25 SE DECISION MADE: 21-NOV-06
4-6 BLD DE BEAUBOURG 510(k) SUMMARY AVAILABLE FROM FDA
MARNE LA VALLEE CEDEX 2, FRANCE 77435
DEVICE: ACTIVASCREW
BIORETEC LTD 510(k) NO: K062980(TRADITIONAL)
ATTN: MARI RUOTSALAINEN PHONE NO : 358 20 7789500
HERMIAKATU 22 MODULIGHT BLDG SE DECISION MADE: 22-NOV-06
TAMERE, FINLAND FI-33720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEPASPHERE MICROSPHERES
BIOSPHERE MEDICAL, INC. 510(k) NO: K052742(TRADITIONAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 07-NOV-06
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP
BLUESHINE SRL 510(k) NO: K063060(TRADITIONAL)
ATTN: ALICE NOVELLI PHONE NO : 39 041 5055847
VIA OLIVI 2 SE DECISION MADE: 29-NOV-06
MESTRE, VENICE, ITALY 30171 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CA
BOSTON SCIENTIFIC CORP. 510(k) NO: K063312(SPECIAL)
ATTN: ROBERT Z PHILLIPS PHONE NO : 510-624-2307
47900 BAYSIDE PARKWAY SE DECISION MADE: 30-NOV-06
FREMONT, CA 94538-6515 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARD COLLAMEND IMPLANT, MODELS 1175102, 1175103, 1175104, 117510
C.R. BARD, INC. 510(k) NO: K063178(TRADITIONAL)
ATTN: STEPHANIE BAKER PHONE NO : 401-215-2252
100 SOCKANOSSETT CROSSROAD SE DECISION MADE: 21-NOV-06
CRANSTON, RI 02920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHERLOCK TLS STYLET, SHERLOCK TLS DETECTOR
C.R. BARD, INC. 510(k) NO: K063240(SPECIAL)
ATTN: LYNN M KIRCHOFF PHONE NO : 801-595-7136
5425 WEST AMELIA EARHART DR. SE DECISION MADE: 21-NOV-06
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CADWELL EASYNET NASAL PRESSURE MODULE
CADWELL LABORATORIES, INC. 510(k) NO: K061705(TRADITIONAL)
ATTN: CHRIS BOLKAN PHONE NO : 509-735-6481
909 NORTH KELLOGG ST. SE DECISION MADE: 21-NOV-06
KENNEWICK, WA 99336 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENLASER 800 PLUS
CAO GROUP, INC. 510(k) NO: K062619(TRADITIONAL)
ATTN: ROBERT K LARSEN PHONE NO : 801-256-9282
4628 WEST SKYHAWK DRIVE SE DECISION MADE: 14-NOV-06
WEST JORDAN, UT 84084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019
CAO GROUP, INC. 510(k) NO: K062886(SPECIAL)
ATTN: ROBERT K LARSEN PHONE NO : 801-256-9282
4628 WEST SKYHAWK DRIVE SE DECISION MADE: 06-NOV-06
WEST JORDAN, UT 84084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO BIOMARC TISSUE MARKER
CARBON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K063193(SPECIAL)
ATTN: ROBERT W JOHNSON PHONE NO : 651-762-2146
1290 HAMMOND RD. SE DECISION MADE: 21-NOV-06
ST. PAUL, MN 55110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C-PORT DISTAL ANASTOMOSIS SYSTEM
CARDICA, INC. 510(k) NO: K053524(TRADITIONAL)
ATTN: DAVID CASAL PHONE NO : 650-364-9975
900 SAGINAW DR. SE DECISION MADE: 16-NOV-06
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X
CARDINAL HEALTH 303, INC. 510(k) NO: K063288(SPECIAL)
ATTN: STACY L LEWIS PHONE NO : 858-458-7830
10221 WATERIDGE CIR. SE DECISION MADE: 28-NOV-06
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM
CARDIO-OPTICS, INC. 510(k) NO: K062340(TRADITIONAL)
ATTN: LARRY BLANKENSHIP PHONE NO : 720-406-1560
2425 55TH ST., SUITE 100 SE DECISION MADE: 30-NOV-06
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODE
CARDIONET, INC 510(k) NO: K063222(SPECIAL)
ATTN: JACK GAIKWAD PHONE NO : 619-243-7500
1010 2ND AVE., SUITE 700 SE DECISION MADE: 14-NOV-06
SAN DIEGO, CA 92101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPRESSIX, COLORCHANGE ALGINATE
CAVEX HOLLAND B.V. 510(k) NO: K062400(TRADITIONAL)
ATTN: RICHARD WOORTMAN PHONE NO : 011 31 235307763
PO BOX 852 SE DECISION MADE: 16-NOV-06
HAARLEM (HOLLAND), NETHERLANDS 200510(k) STATEMENT
DEVICE: APERFIX FEMORAL IMPLANT WITH INSERTER
CAYENNE MEDICAL, INC. 510(k) NO: K062487(TRADITIONAL)
ATTN: FLOYD LARSON PHONE NO : 858-792-1235
11234 EL CAMINO REAL SE DECISION MADE: 17-NOV-06
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92130
DEVICE: 3MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-3NC
CHI LIN TECHNOLOGY CO., LTD. 510(k) NO: K063266(TRADITIONAL)
ATTN: JUDY LIN PHONE NO : 886 2 26006368
3F, # 86, SEC 1 WUNHUA 1ST RD. SE DECISION MADE: 09-NOV-06
LINKUO, TAIPEI HSIEN, CHINA (TAIWA510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: 2MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-2NC
CHI LIN TECHNOLOGY CO., LTD. 510(k) NO: K063289(TRADITIONAL)
ATTN: JUDY LIN PHONE NO : 886 2 26006368
3F, # 86, SEC 1 WUNHUA 1ST RD. SE DECISION MADE: 16-NOV-06
LINKUO, TAIPEI HSIEN, CHINA (TAIWA510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22
CHOICE SMART HEALTH CARE COMPANY L510(k) NO: K063291(TRADITIONAL)
ATTN: JANICE MA PHONE NO : 86 21 63345066
2108 CIRO'S PLAZA SE DECISION MADE: 21-NOV-06
388 WEST NANJING ROAD 510(k) SUMMARY AVAILABLE FROM FDA
SHANGHAI, CHINA 200003 THIRD PARTY REVIEW
DEVICE: CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIF
CIBA VISION CORPORATION 510(k) NO: K062262(TRADITIONAL)
ATTN: ALICIA M PLESNARSKI PHONE NO : 678-415-3924
11460 JOHNS CREEK PARKWAY SE DECISION MADE: 14-NOV-06
DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I-STOP TRANS OBTURATOR MALE SLING
CL MEDICAL 510(k) NO: K063079(TRADITIONAL)
ATTN: VINCENT GORIA PHONE NO : 330 478 595493
28 AVENUE GENERAL DE GAULLE SE DECISION MADE: 07-NOV-06
SAINTE FOY LES LYON, FRANCE F-6911510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET
COMPASS BIOSCIENCE 510(k) NO: K062593(TRADITIONAL)
ATTN: CARTER GRANDJEAN PHONE NO : 626-359-9645
1850 EVERGREEN ST. SE DECISION MADE: 22-NOV-06
DUARTE, CA 91010-2906 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASOPRESS DVT SYSTEM, MODEL VP500D
COMPRESSION THERAPY CONCEPTS, INC.510(k) NO: K061814(TRADITIONAL)
ATTN: LEONARD NASS PHONE NO : 908-822-1488
1750 BRIELLE AVE. SE DECISION MADE: 30-NOV-06
SUITE B6 510(k) STATEMENT
WANAMASSA, NJ 07712
DEVICE: MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT
CONTAMAC LTD. 510(k) NO: K062548(SPECIAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
2214 SANFORD DRIVE SE DECISION MADE: 01-NOV-06
UNIT B7 510(k) SUMMARY AVAILABLE FROM FDA
GRAND JUNCTION, CO 81505
DEVICE: ATB ADVANCED PTA DILATATION CATHETER
COOK, INC. 510(k) NO: K063252(SPECIAL)
ATTN: KAREN BRADBURN PHONE NO : 812-339-2235
750 DANIELS WAY PO BX 489 SE DECISION MADE: 14-NOV-06
BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT
COOPERVISION, INC. 510(k) NO: K061948(TRADITIONAL)
ATTN: LISA HAHN PHONE NO : 757-664-2421
1215 BOISSEVAIN AVE. SE DECISION MADE: 22-NOV-06
NORFOLK, VA 23507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31
CP MEDICAL 510(k) NO: K060987(TRADITIONAL)
ATTN: BETSY CORTELLONI PHONE NO : 770-831-4294
5203 BRISTOL INDUSTRIAL WAY SE DECISION MADE: 02-NOV-06
BUFORD, GA 30518 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROPATCH SOFT TISSUE REPAIR MATRIX
CRYOLIFE, INC. 510(k) NO: K061892(ABBREVIATED)
ATTN: JOHN D FERROS PHONE NO : 770-419-3355
1655 ROBERTS BLVD., N.W. SE DECISION MADE: 22-NOV-06
KENNESAW, GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH NIT
DADE BEHRING, INC. 510(k) NO: K062938(TRADITIONAL)
ATTN: ROBERT EUSEBIO PHONE NO : 916-374-3183
2040 ENTERPRISE BLVD. SE DECISION MADE: 20-NOV-06
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML)
DADE BEHRING, INC. 510(k) NO: K063099(TRADITIONAL)
ATTN: MAY MORISHIMA PHONE NO : 916-374-2006
2040 ENTERPRISE BLVD. SE DECISION MADE: 01-NOV-06
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML
DADE BEHRING, INC. 510(k) NO: K063101(TRADITIONAL)
ATTN: MAUREEN MENDE PHONE NO : 916-374-3174
2040 ENTERPRISE BLVD. SE DECISION MADE: 01-NOV-06
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML)
DADE BEHRING, INC. 510(k) NO: K063102(TRADITIONAL)
ATTN: SHANNON POPSON PHONE NO : 916-374-3330
2040 ENTERPRISE BLVD. SE DECISION MADE: 09-NOV-06
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN
DADE BEHRING, INC. 510(k) NO: K063299(TRADITIONAL)
ATTN: MAY MORISHIMA PHONE NO : 916-374-2006
1584 ENTERPRISE BLVD. SE DECISION MADE: 27-NOV-06
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GAS MODULE SE, MODEL 0998-00-0481-02
DATASCOPE CORP. 510(k) NO: K062754(TRADITIONAL)
ATTN: KATHLEEN KRAMER PHONE NO : 201-995-8169
800 MACARTHUR BLVD. SE DECISION MADE: 02-NOV-06
MAHWAH, NJ 07430-0619 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOYAGER 12
DEL MAR REYNOLDS MEDICAL, LTD. 510(k) NO: K062469(SPECIAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 S SE DECISION MADE: 03-NOV-06
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEL-IMS
DEL MEDICAL IMAGING CORP. 510(k) NO: K063188(TRADITIONAL)
ATTN: WILLIAM J ENGEL PHONE NO : 847-288-7948
11550 WEST KING ST. SE DECISION MADE: 30-NOV-06
FRANKLIN PARK, IL 60131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOMAS PIN SD 6, 8, AND 10 MM
DENTAURUM 510(k) NO: K062733(TRADITIONAL)
ATTN: CHARLES R BELL PHONE NO : 267-756-6517
10 PHEASANT RUN SE DECISION MADE: 09-NOV-06
NEWTOWN, PA 18940 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOUTHGUARD AND ALIGNER MATERIALS
DENTSPLY INTL., INC. 510(k) NO: K062828(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
SUSQUEHANNA COMMERCE CENTER SE DECISION MADE: 27-NOV-06
221 W PHILADELPHIA ST. STE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTUR
DEPUY MILTEK, A JOHNSON & JOHNSON 510(k) NO: K063273(SPECIAL)
ATTN: KRISTINE CHRISTO PHONE NO : 508-828-3359
325 PARAMOUNT DR. SE DECISION MADE: 22-NOV-06
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K062748(SPECIAL)
ATTN: ANNE M SCHULER PHONE NO : 574-372-7098
700 ORTHOPAEDIC DR. SE DECISION MADE: 30-NOV-06
P.O BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: MODIFICATION TO EXPEDIUM SPINE SYSTEM
DEPUY SPINE, INC. 510(k) NO: K062174(SPECIAL)
ATTN: MARY GRAY PHONE NO : 508-828-3649
325 PARAMOUNT DR. SE DECISION MADE: 02-NOV-06
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO EXPEDIUM SPINE SYSTEM
DEPUY SPINE, INC. 510(k) NO: K063156(SPECIAL)
ATTN: CHRISTOPHER KLACZYK PHONE NO : 508-828-2852
325 PARAMOUNT DR. SE DECISION MADE: 22-NOV-06
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
DIAGNOSTIC HYBRIDS, INC. 510(k) NO: K061101(TRADITIONAL)
ATTN: GAIL R GOODRUM PHONE NO : 740-593-1784
350 WEST STATE ST. SE DECISION MADE: 20-NOV-06
ATHENS, OH 45701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONFIDENCE FENESTRATED INTRODUCER NEEDLE
DISC-O-TECH MEDICAL TECHNOLOGIES, 510(k) NO: K063067(SPECIAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 03-NOV-06
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCU-CHEK LINKASSIST
DISETRONIC MEDICAL SYSTEMS AG 510(k) NO: K063146(TRADITIONAL)
ATTN: SCOTT THIEL PHONE NO : 800-428-5074
9115 HAGUE ROAD SE DECISION MADE: 27-NOV-06
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900
E-Z-EM, INC. 510(k) NO: K063029(SPECIAL)
ATTN: TRACEY CAMPBELL PHONE NO : 516-333-8230
750 SUMMA AVE. SE DECISION MADE: 02-NOV-06
WESTBURY, NY 11590 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IQQA-LIVER SOFTWARE
EDDA TECHNOLOGY, INC. 510(k) NO: K061696(TRADITIONAL)
ATTN: XIAOLAN ZENG PHONE NO : 609-936-8282
14 WASHINGTON ROAD SE DECISION MADE: 13-NOV-06
BUILDING 2 510(k) SUMMARY AVAILABLE FROM FDA
PRINCETON JUNCTION, NJ 08550 THIRD PARTY REVIEW
DEVICE: COLOR LCD MONITOR, RADIFORCE, MODEL RX210
EIZO NANAO CORPORATION 510(k) NO: K063120(SPECIAL)
ATTN: HIROAKI HASHIMOTO PHONE NO : 81 76 2742468
153 SHIMOKASHIWANO-CHO SE DECISION MADE: 09-NOV-06
MATTO-SHI 510(k) SUMMARY AVAILABLE FROM FDA
ISHIKAWA-KEN, JAPAN 924-8566
DEVICE: MICRO-INFUSION SYSTEM
EKOS CORP. 510(k) NO: K062507(SPECIAL)
ATTN: JOCELYN KERSTEN PHONE NO : 425-415-3132
11911 NORTH CREEK PKWY. SOUTH SE DECISION MADE: 22-NOV-06
BOTHELL, WA 98011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMG AC/DC SUCTION UNIT
EMG TECHNOLOGY CO., LTD. 510(k) NO: K063448(TRADITIONAL)
ATTN: SALLY CHUANG PHONE NO : 04 235 96033
4F-2, NO. 210, 38 RD. SE DECISION MADE: 30-NOV-06
TAICHUNG INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
SHITUEN CHIU, TAICHUNG, CHINA (TAITHIRD PARTY REVIEW
DEVICE: FMP COATED SPIKED ACETABULAR CUP; HEMISPHERICAL ACETABULAR CUP;
ENCORE MEDICAL, L.P. 510(k) NO: K063257(SPECIAL)
ATTN: TEFFANY HUTTO PHONE NO : 512-834-6225
9800 METRIC BLVD. SE DECISION MADE: 22-NOV-06
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAPMATE
EP MEDSYSTEMS, INC. 510(k) NO: K063277(SPECIAL)
ATTN: LARRY PICCIANO PHONE NO : 856-753-8533
COOPER RUN EXECUTIVE PARK SE DECISION MADE: 30-NOV-06
575 ROUTE 73 NORTH, BUILDING D 510(k) SUMMARY AVAILABLE FROM FDA
WEST BERLIN, NJ 08091-9293
DEVICE: S-SCAN MRI SYSTEM
ESAOTE, S.P.A. 510(k) NO: K063207(SPECIAL)
ATTN: CARRI GRAHAM PHONE NO : 317-569-9500
11460 N MERIDIAN ST., STE 150 SE DECISION MADE: 09-NOV-06
CARMEL, IN 46032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIDERFX EMBOLIC PROTECTION DEVICE
EV3 INC 510(k) NO: K063204(SPECIAL)
ATTN: DAVID WORRELL PHONE NO : 763-398-7344
9600 54TH AVENUE NORTH SE DECISION MADE: 14-NOV-06
PLYMOUTH, MN 55442-2920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVATION SPLINED RDD FEMORAL STEMS
EXACTECH, INC. 510(k) NO: K063279(SPECIAL)
ATTN: MARITZA ELIAS PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 29-NOV-06
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091
GEN-PROBE, INC. 510(k) NO: K062440(TRADITIONAL)
ATTN: E JOSEPH MCMULLEN PHONE NO : 858-410-8649
10210 GENETIC CENTER DR. SE DECISION MADE: 07-NOV-06
SAN DIEGO, CA 92121-4362 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE LOGIQ WORKS
GENERAL ELECTRIC CO. 510(k) NO: K063006(SPECIAL)
ATTN: ALLEN SCHUH PHONE NO : 414-721-3992
9900 INNOVATION DRIVE SE DECISION MADE: 02-NOV-06
WAUWATOSA, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GOLDEN LITEWAY
GOLDEN TECHNOLOGIES, INC. 510(k) NO: K063162(SPECIAL)
ATTN: GENE R KULON PHONE NO : 800-624-6374
401 BRIDGE ST. SE DECISION MADE: 02-NOV-06
OLD FORGE, PA 18518 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GREENTON ECOLITE IPL SYSTEM
GREENTON (LONDON) LTD. 510(k) NO: K062721(TRADITIONAL)
ATTN: ROBERT T HANDREN PHONE NO : 352-314-8829
5818 PRINCESS CAROLINE PLACE SE DECISION MADE: 21-NOV-06
LEESBURG, FL 34748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HAGER MIRAMATIC BOX SHARPS CONTAINER AND CAP TRAP NEEDLE RE-CAPP
HAGER WORLDWIDE, INC. 510(k) NO: K061933(TRADITIONAL)
ATTN: JAMES DELANEY PHONE NO : 978-475-5692
4 LINCOLN ST SE DECISION MADE: 16-NOV-06
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITRILE POWDER FREE EXAMINATION GLOVES (GREEN)
HARTALEGA SDN BHD 510(k) NO: K063046(TRADITIONAL)
ATTN: NURUL A KONG PHONE NO : 603 327 10277
NO. 7, KAWASAN PERUSAHAAN SE DECISION MADE: 17-NOV-06
SURIA 510(k) STATEMENT
BATAN BERJUNTAI, MALAYSIA 45600
DEVICE: RETENTION FLOW OPAQUE
HERAEUS KULZER GMBH 510(k) NO: K062515(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN PHONE NO : 574-291-0661
4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 22-NOV-06
SOUTH BEND, IN 46614-2517 510(k) STATEMENT
DEVICE: EQUIVITAL, MODEL EQ-01
HIDALGO LIMITED 510(k) NO: K061993(TRADITIONAL)
ATTN: JUSTIN PISANI PHONE NO : 441 954 233430
STABLE BLOCK AT THE GRANGE SE DECISION MADE: 03-NOV-06
20 MARKET STREET 510(k) SUMMARY AVAILABLE FROM FDA
SWAVESEY CAMBRIDGE, UNITED KINGDOM CB4-5QG
DEVICE: MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER
HITACHI MEDICAL CORP. 510(k) NO: K061608(SPECIAL)
ATTN: DOUG THISTLETHWAITE PHONE NO : 330-425-1313
1959 SUMMIT COMMERCE PARK SE DECISION MADE: 22-NOV-06
TWINSBURGH, OH 44087-2371 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN
HOSPIRA, INC. 510(k) NO: K062999(SPECIAL)
ATTN: DIANE RENNPFERD PHONE NO : 224-212-5452
275 NORTH FIELD DR. SE DECISION MADE: 03-NOV-06
DEPT. 389, BLDG. H2-2 510(k) SUMMARY AVAILABLE FROM FDA
LAKE FOREST, IL 60045
DEVICE: TRIDENT LARGE DIAMETER ACETABULAR INSERTS
HOWMEDICA OSTEONICS CORP 510(k) NO: K062419(TRADITIONAL)
ATTN: TIFFANI ROGERS PHONE NO : 201-831-5612
325 CORPORATE DR. SE DECISION MADE: 15-NOV-06
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY V
HYPERMED, INC. 510(k) NO: K061848(TRADITIONAL)
ATTN: CHAS BURR PHONE NO : 781-789-1646
11 MYSTIC AVE. SE DECISION MADE: 08-NOV-06
WINCHESTER, MA 01890-2920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ON-Q INTRODUCERS
I-FLOW CORP. 510(k) NO: K063234(ABBREVIATED)
ATTN: SHANE NOEHRE PHONE NO : 949-206-2653
20202 WINDROW DR. SE DECISION MADE: 21-NOV-06
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XPLORER 2200 DIGITAL RADIOGRAPHIC SYSTEM
IMAGING DYNAMICS COMPANY LTD. 510(k) NO: K063039(SPECIAL)
ATTN: SHIRANTHA SAMARAPPULI PHONE NO : 403 251 9939
151,2340 PEGASUS WAY, NE SE DECISION MADE: 02-NOV-06
CALGARY, ALBERTA, CANADA T2E 8M5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XPLORER 1500 DIGITAL RADIOGRAPHIC SYSTEM WITH STAND
IMAGING DYNAMICS COMPANY LTD. 510(k) NO: K063246(SPECIAL)
ATTN: SHIRANTHA SAMARAPPULI PHONE NO : 403 251 9939
151,2340 PEGASUS WAY, NE SE DECISION MADE: 22-NOV-06
CALGARY, ALBERTA, CANADA T2E 8M5 510(k) STATEMENT
DEVICE: XPLORER 1800 DIGITAL RADIOGRAPHIC SYSTEM WITH UNIVERSAL STAND
IMAGING DYNAMICS COMPANY LTD. 510(k) NO: K063247(SPECIAL)
ATTN: SHIRANTHA SAMARAPPULI PHONE NO : 403 251 9939
151,2340 PEGASUS WAY, NE SE DECISION MADE: 22-NOV-06
CALGARY, ALBERTA, CANADA T2E 8M5 510(k) STATEMENT
DEVICE: IVUS ENHANCER
INDEC SYSTEMS, INC. 510(k) NO: K062985(TRADITIONAL)
ATTN: CAROL HUBLER PHONE NO : 408-986-1600
2210 MARTIN AVE. SE DECISION MADE: 22-NOV-06
SANTA CLARA, CA 95050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INION ANCHRON PLUS BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6001
INION OY 510(k) NO: K062782(SPECIAL)
ATTN: KATI MARTTINEN PHONE NO : 358 3 2306600
LAAKARINKATU 2 SE DECISION MADE: 09-NOV-06
TAMPERE, FINLAND 33520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INNOVACON SPECTRUM II TEST CARD
INNOVACON, INC. 510(k) NO: K061718(SPECIAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4106 SORRENTO VALLEY BLVD. SE DECISION MADE: 13-NOV-06
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOAGGREGATE
INNOVATIVE BIOCERAMIX INC. 510(k) NO: K063422(TRADITIONAL)
ATTN: QUANZU YANG PHONE NO : 604 221 6800
3650 WESBROOK MALL SE DECISION MADE: 21-NOV-06
VANCOUVER, BC, CANADA V6S 2L2 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SERENITY PSF (PNEUMATIC SKIN FLATTENING) SYSTEM
INOLASE 2002, LTD. 510(k) NO: K062589(TRADITIONAL)
ATTN: GEORGE J HATTUB PHONE NO : 508-479-6116
291 HILLSIDE AVENUE SE DECISION MADE: 30-NOV-06
SOMERSET, MA 02726 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IRIDEX WIRELESS FOOTSWITCH
IRIDEX CORP. 510(k) NO: K062074(TRADITIONAL)
ATTN: JOHN JOSSY PHONE NO : 650-962-8848
1212 TERRA BELLA AVE. SE DECISION MADE: 14-NOV-06
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IRIDEX OCULIGHT TX
IRIDEX CORP. 510(k) NO: K062369(TRADITIONAL)
ATTN: JOHN JOSSY PHONE NO : 650-962-8848
1212 TERRA BELLA AVE. SE DECISION MADE: 08-NOV-06
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE
ISORAY, INC 510(k) NO: K062384(SPECIAL)
ATTN: DAVID J SWANBERG PHONE NO : 509-375-1202
350 HILLS ST. SE DECISION MADE: 09-NOV-06
SUITE 106 510(k) SUMMARY AVAILABLE FROM FDA
RICHLAND, WA 99354-5411
DEVICE: ADHESIVE DC ACTIVATOR
IVOCLAR VIVADENT, INC. 510(k) NO: K062713(TRADITIONAL)
ATTN: ANDERJEET S GULATI PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 02-NOV-06
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU
JINDELL MEDICAL INSTRUMENTS CO., L510(k) NO: K062740(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 02-NOV-06
HSIN-CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AN
JOHNSON & JOHNSON VISION CARE, INC510(k) NO: K062614(SPECIAL)
ATTN: SUSAN MORRIS PHONE NO : 904-443-1828
7500 CENTURION PKWY. SE DECISION MADE: 01-NOV-06
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32256
DEVICE: KARL STORZ VIDEO GASTROSCOPES
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K060907(TRADITIONAL)
ATTN: PAUL S LEE PHONE NO : 310-410-2769
600 CORPORATE POINTE DRIVE SE DECISION MADE: 09-NOV-06
CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYOMATIC
KEELER INSTRUMENTS, INC. 510(k) NO: K062412(TRADITIONAL)
ATTN: EUGENE R VANARSDALE PHONE NO : 610-353-4350
456 PARKWAY SE DECISION MADE: 06-NOV-06
BROOMALL, PA 19008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND S
KENDALL 510(k) NO: K062671(SPECIAL)
ATTN: KEITH MARTIN PHONE NO : 508-261-8440
15 HAMPSHIRE ST. SE DECISION MADE: 03-NOV-06
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECLIPSE TOTAL ANKLE IMPLANT
KINETIKOS MEDICAL, INC. 510(k) NO: K061749(TRADITIONAL)
ATTN: JOHN G STAMPINATO PHONE NO : 760-448-1706
6005 HIDDEN VALLEY RD, STE 180 SE DECISION MADE: 22-NOV-06
CARLSBAD, CA 92011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLS MARTIN QUICK DISC
KLS MARTIN L.P. 510(k) NO: K062857(TRADITIONAL)
ATTN: JENNIFER DAMATO PHONE NO : 904-634-7746
11239 ST. JOHNS INDUSTRIAL SE DECISION MADE: 22-NOV-06
PARKWAY SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32246
DEVICE: KOWA VX-10I
KOWA CO. LTD. 510(k) NO: K062021(TRADITIONAL)
ATTN: RICHARD PHILLIPS PHONE NO : 301-272-3115
1801 ROCKVILLE PIKE SE DECISION MADE: 01-NOV-06
SUITE 300 510(k) STATEMENT
ROCKVILLE, MD 20852
DEVICE: K-ETCHANT GEL
KURARAY MEDICAL INC. 510(k) NO: K062409(TRADITIONAL)
ATTN: KOJI NISHIDA PHONE NO : 212-986-2230
600 LEXINGTON AVENUE SE DECISION MADE: 08-NOV-06
26TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10022
DEVICE: PRISM VIEW, MODEL
KYRON CLINICAL IMAGING, INC. 510(k) NO: K063031(SPECIAL)
ATTN: JAMES L REUSS, PH.D. PHONE NO : 414-745-3042
2457 N. MAYFAIR RD., SUITE 202 SE DECISION MADE: 02-NOV-06
WAUWATOSA, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04
LEONHARD LANG GMBH 510(k) NO: K063161(SPECIAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035
P.O. BOX 560 SE DECISION MADE: 21-NOV-06
STILLWATER, MN 55082-0560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KINETIC ANTERIOR CERVICAL PLATE
LIFE SPINE 510(k) NO: K062643(SPECIAL)
ATTN: ERIN MALLOY PHONE NO : 847-884-6117
2400 HASSELL ROAD SE DECISION MADE: 16-NOV-06
SUITE 370 510(k) SUMMARY AVAILABLE FROM FDA
HOFFMAN ESTATES, IL 60169
DEVICE: PRIMACONNEX CERAMIC ABUTMENTS
LIFECORE BIOMEDICAL, INC. 510(k) NO: K062876(TRADITIONAL)
ATTN: BRIAN SMEKAL PHONE NO : 952-368-6306
3515 LYMAN BLVD. SE DECISION MADE: 01-NOV-06
CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LONGPORT EPISCAN, MODEL-I-200
LONGPORT, INC. 510(k) NO: K062571(TRADITIONAL)
ATTN: MICHAEL G FARROW PHONE NO : 202-285-2626
4239 32ND ROAD, SOUTH SE DECISION MADE: 21-NOV-06
ARLINGTON, VA 22206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730
LOUIS M. GERSON CO., INC. 510(k) NO: K061375(TRADITIONAL)
ATTN: ROBERT BRUNELL PHONE NO : 508-923-2145
15 SPROAT ST. SE DECISION MADE: 17-NOV-06
MIDDLEBORO, MA 02346 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CELLU M6 KEYMODULE I
LPG ONE, INC 510(k) NO: K053225(TRADITIONAL)
ATTN: JAY MANSOUR PHONE NO : 770-777-4146
845 ARONSON LAKE COURT SE DECISION MADE: 06-NOV-06
ROSWELL, GA 30075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUMACARE LC-122M NON-COHERENT LIGHT SOURCE
LYNTON LASERS LIMITED 510(k) NO: K062871(TRADITIONAL)
ATTN: ANDREW J BERRY PHONE NO : 44 147 7536977
LYNTON HOUSE, MANOR LANE SE DECISION MADE: 14-NOV-06
HOLMES CHAPEL, CHESHIRE, UNITED KI510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MILLENIUM SERIES, INCLUDING MILLENIUM B, B+, B2 AND BU
M.O.C.O.M. SRL 510(k) NO: K050263(ABBREVIATED)
ATTN: DANIELE TOSI PHONE NO : 39 02 45701505
VIA DELLE AZALEE 1 SE DECISION MADE: 21-NOV-06
BUCCINASCO (MI), ITALY 20090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M3
MAVIG GMBH 510(k) NO: K063333(TRADITIONAL)
ATTN: CHRISTIAN STOIAN PHONE NO : 49 89 42096233
STAHLGRUBERRING 5 SE DECISION MADE: 21-NOV-06
MUNCHEN, GERMANY 81829 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SMITHWICK CAROTID SHUNT
MCPHERSON ENTERPRISES, INC. 510(k) NO: K062474(TRADITIONAL)
ATTN: WILLIAM MCPHERSON PHONE NO : 813-931-4201
3851 62ND AVE. N. SE DECISION MADE: 09-NOV-06
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
PINELLAS PARK, FL 33781
DEVICE: HORIZON CARDIOLOGY ECG-MCKESSON'S ECG MANAGEMENT SYSTEM, MODEL 1
MEDCON LTD. 510(k) NO: K061905(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 08-NOV-06
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDIC4ALL TELEMEDICINE SYSTEM, MODEL VMS-01 (NIBP)
MEDIC4ALL (ISRAEL) LTD. 510(k) NO: K062127(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 08-NOV-06
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TELEMEDICINE SYSTEM MODEL VMS-01
MEDIC4ALL (ISRAEL) LTD. 510(k) NO: K062662(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 21-NOV-06
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FERRITIN-LATEX, MODELS 1418-2070, 1418-0279
MEDICON HELLAS S.A. 510(k) NO: K062746(TRADITIONAL)
ATTN: GEORGE PSICHAS PHONE NO : 302 106 606140
5-7 MELITONA ST. SE DECISION MADE: 20-NOV-06
GERAKAS, ATTIKI, GREECE 15344 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VENTED VIAL ADAPTER TRANSFER DEVICE
MEDIMOP MEDICAL PROJECTS, LTD. 510(k) NO: K062482(TRADITIONAL)
ATTN: ARI Y SOBEL PHONE NO : 972 9 7757122
17 HAYETZIRA ST. P.O. BOX 2499 SE DECISION MADE: 03-NOV-06
RAANANA, ISRAEL 43665 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDLINE SURGICAL SPONGE SCANNER
MEDLINE INDUSTRIES, INC. 510(k) NO: K061316(TRADITIONAL)
ATTN: LARA N SIMMONS PHONE NO : 847-837-2759
ONE MEDLINE PL. SE DECISION MADE: 02-NOV-06
MUNDELEIN, IL 60060 510(k) STATEMENT
DEVICE: MEDLINE HYPODERMIC NEEDLES
MEDLINE INDUSTRIES, INC. 510(k) NO: K062984(ABBREVIATED)
ATTN: LARA N SIMMONS PHONE NO : 847-682-0224
ONE MEDLINE PL. SE DECISION MADE: 13-NOV-06
MUNDELEIN, IL 60060 510(k) STATEMENT
DEVICE: MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS
MEDRAD, INC. 510(k) NO: K063342(SPECIAL)
ATTN: LISA A EWING PHONE NO : 412-767-2400
ONE MEDRAD DR. SE DECISION MADE: 30-NOV-06
INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX
MEDTRONIC NEUROSURGERY 510(k) NO: K063117(SPECIAL)
ATTN: JEFFERY HENDERSON PHONE NO : 805-968-1546
125 CREMONA DR. SE DECISION MADE: 03-NOV-06
GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TSRH SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K062807(TRADITIONAL)
ATTN: EDWARD CHIN PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 06-NOV-06
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K063083(SPECIAL)
ATTN: EDWARD S CHIN PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 06-NOV-06
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STIMULATING BUR GUARD
MEDTRONIC XOMED, INC. 510(k) NO: K063305(TRADITIONAL)
ATTN: ANTOINE KOUCHAKJY PHONE NO : 904-296-9600
6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 29-NOV-06
JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOVIEW
MERDIAN TECHNIQUE, LTD. 510(k) NO: K063327(TRADITIONAL)
ATTN: ANTHONY THORNE PHONE NO : 44 123 5820401
UNIT 7 BUILDING T2, AREA 200 SE DECISION MADE: 22-NOV-06
MILTON PARK, ABINGDON, UNITED KING510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ENA HFO COMPOSITE SYSTEM
MICERIUM S.P.A. 510(k) NO: K062906(TRADITIONAL)
ATTN: EUGENIO MICELI PHONE NO : 390 185 7885880
VIA MARCONI 83 SE DECISION MADE: 17-NOV-06
AVENGO, ITALY 16030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTABLE OXYGEN GENERATOR SYSTEM
MOLECULAR PRODUCTS LTD. 510(k) NO: K062153(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
3460 POINTE CREEK CT. SE DECISION MADE: 21-NOV-06
# 102 510(k) SUMMARY AVAILABLE FROM FDA
BONITA SPRINGS, FL 34134
DEVICE: ELI 350 ELECTROCARDIOGRAPH
MORTARA INSTRUMENT, INC. 510(k) NO: K062677(SPECIAL)
ATTN: HARLAN VAN MATRE PHONE NO : 414-354-1600
7865 NORTH 86TH ST. SE DECISION MADE: 15-NOV-06
MILWAUKEE, WI 53224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
NEW LEAF MEDICAL, INC. 510(k) NO: K061829(TRADITIONAL)
ATTN: RICHARD T NOCK PHONE NO : 440-748-7000
11476 HAWKE RD SE DECISION MADE: 17-NOV-06
SUITE #C 510(k) SUMMARY AVAILABLE FROM FDA
COLUMBIA STATION, OH 44028
DEVICE: SBF 15 ESTHETIC ABUTMENT 1MM NP, MODEL 33699, SFB 15 ESTHETIC AB
NOBEL BIOCARE AB 510(k) NO: K062749(TRADITIONAL)
ATTN: HERBERT CRANE PHONE NO : 714 282 5074
15 BOHUSGATAN, SE DECISION MADE: 29-NOV-06
P.O. BOX 5190 510(k) SUMMARY AVAILABLE FROM FDA
GOTEBORG, SWEDEN S-402 26
DEVICE: ADJUSTABLE MULTI-CATHETER SOURCE APPLICTOR
NORTH AMERICAN SCIENTIFIC, INC. 510(k) NO: K062241(TRADITIONAL)
ATTN: LEIGH SPOTTEN PHONE NO : 818-734-8600
20200 SUNBURST ST. SE DECISION MADE: 09-NOV-06
CHATSWORTH, CA 91311 510(k) STATEMENT
DEVICE: STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+
NOVA BIOMEDICAL CORP. 510(k) NO: K061830(TRADITIONAL)
ATTN: PAUL W MACDONALD PHONE NO : 781-894-0800
200 PROSPECT ST. SE DECISION MADE: 01-NOV-06
WALTHAM, MA 02454-9141 510(k) STATEMENT
DEVICE: FLEXPEN NEEDLE
NOVO NORDISK INC. 510(k) NO: K062500(TRADITIONAL)
ATTN: RICK SPRING PHONE NO : 609-987-5046
100 COLLEGE ROAD WEST SE DECISION MADE: 21-NOV-06
PRINCETON, NJ 08540-7810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOAS
OLYMPUS AMERICA, INC. 510(k) NO: K062581(TRADITIONAL)
ATTN: DAVID DAVIS PHONE NO : 972-556-9697
3131 WEST ROYAL LN. SE DECISION MADE: 29-NOV-06
IRVING, TX 75063-3104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNIGUIDE ZERO FLOW ZF-T 150 WAVEGUIDE FIBER
OMNIGUIDE, INC. 510(k) NO: K063141(TRADITIONAL)
ATTN: DOUGLAS W WOODRUFF PHONE NO : 617-551-8404
ONE KENDALL SQUARE, BLDG 100 SE DECISION MADE: 29-NOV-06
3RD FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
CAMBRIDGE, MA 02139 THIRD PARTY REVIEW
DEVICE: BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500
OMRON HEALTHCARE, INC. 510(k) NO: K062043(TRADITIONAL)
ATTN: DONNA DJINOVICH PHONE NO : 847-247-5713
1200 LAKESIDE DRIVE SE DECISION MADE: 07-NOV-06
BANNOCKBURN, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONCOBIONIC SYSTEM
ONCOBIONICS, INC. 510(k) NO: K060054(TRADITIONAL)
ATTN: LAURIE A CLARKE PHONE NO : 202-626-2645
1700 PENNSYLVANIA AVENUE, NW SE DECISION MADE: 21-NOV-06
WASHINGTON, DC 20006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPID STRAND RX
ONCURA INC. 510(k) NO: K063177(TRADITIONAL)
ATTN: SUBHASH PATEL PHONE NO : 732-821-7021
43 PALMETTO WAY SE DECISION MADE: 30-NOV-06
NORTH BRUNSWICK, NJ 08902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RETINAL FUNCTIONAL IMAGER (RFI)
OPTICAL IMAGING LTD. 510(k) NO: K062416(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH ST. NW SE DECISION MADE: 17-NOV-06
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS CHEMISTRY PRODUCTS AMPH REAGENT; CALIBRATOR KIT 26; FS CA
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K062077(TRADITIONAL)
ATTN: MARLENE A HANNA PHONE NO : 585-453-4041
100 INDIGO CREEK DR. SE DECISION MADE: 22-NOV-06
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CAL
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K062094(TRADITIONAL)
ATTN: DARLENE J PHILLIPS PHONE NO : 585-453-4253
100 INDIGO CREEK DR. SE DECISION MADE: 22-NOV-06
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CA
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K062123(TRADITIONAL)
ATTN: MICHAEL M BYRNE PHONE NO : 585-453-3143
100 INDIGO CREEK DR. SE DECISION MADE: 16-NOV-06
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT P
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K062637(TRADITIONAL)
ATTN: DARLENE J PHILLIPS PHONE NO : 585-453-4253
100 INDIGO CREEK DR. SE DECISION MADE: 22-NOV-06
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K063144(SPECIAL)
ATTN: SARAH C PARSONS PHONE NO : 585-543-3154
100 INDIGO CREEK DR. SE DECISION MADE: 13-NOV-06
MC881 510(k) SUMMARY AVAILABLE FROM FDA
ROCHESTER, NY 14626-5101
DEVICE: ORTHOCON HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY
ORTHOCON, INC. 510(k) NO: K063330(SPECIAL)
ATTN: HOWARD L SCHRAYER PHONE NO : 732-683-9304
167 STONE HILL RD. SE DECISION MADE: 22-NOV-06
COLTS NECK, NJ 07722 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP
ORTHOFIX SRL 510(k) NO: K062920(TRADITIONAL)
ATTN: CANDACE F CEDERMAN PHONE NO : 503-722-7494
15058 ARMEL DR. SE DECISION MADE: 13-NOV-06
OREGON CITY, OR 97045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANT
ORTHOPEDIC SCIENCES, INC 510(k) NO: K063033(SPECIAL)
ATTN: JAMES BRANNON M.D. PHONE NO : 562-799-5550
3020 OLD RANCH PARKWAY SE DECISION MADE: 01-NOV-06
SUITE 325 510(k) SUMMARY AVAILABLE FROM FDA
SEAL BEACH, CA 90740
DEVICE: ORTHROPRO HEMI TOE
ORTHOPRO LLC 510(k) NO: K062908(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 13-NOV-06
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: US SYSTEM
OSSTEM IMPLANT CO.,LTD 510(k) NO: K062030(ABBREVIATED)
ATTN: CATHRYN N CAMBRIA PHONE NO : 770-396-5909
5536 TROWBRIDGE DRIVE SE DECISION MADE: 02-NOV-06
DUNWOODY, GA 30338 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SS SYSTEM
OSSTEM IMPLANT CO.,LTD 510(k) NO: K062051(ABBREVIATED)
ATTN: CATHRYN N CAMBRIA PHONE NO : 770-396-5909
5536 TROWBRIDGE DRIVE SE DECISION MADE: 01-NOV-06
DUNWOODY, GA 30338 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTE
OSTEOMED L.P. 510(k) NO: K062851(TRADITIONAL)
ATTN: PIEDAD PENA PHONE NO : 972-677-4600
3885 ARAPAHO RD. SE DECISION MADE: 17-NOV-06
ADDISON, TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPIRUN H. PYLORI ANTIBODY DETECTION KIT
OTSUKA PHARMACEUTICAL CO., LTD. 510(k) NO: K052716(TRADITIONAL)
ATTN: CYNTHIA A SINCLAIR PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 16-NOV-06
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMAX CEPH DIGITAL X-RAY SENSOR
OWANDY 510(k) NO: K062403(TRADITIONAL)
ATTN: CLAUDE D BERTHOIN PHONE NO : 386-672-0450
110 E. GRANADA BLVD. SE DECISION MADE: 14-NOV-06
SUITE 207 510(k) STATEMENT
ORMOND BEACH, FL 32176
DEVICE: AURORA
PARKELL, INC. 510(k) NO: K063003(TRADITIONAL)
ATTN: DANIEL R SCHECHTER PHONE NO : 631-249-1134
300 EXECUTIVE DR. SE DECISION MADE: 28-NOV-06
EDGEWOOD, NY 11717 510(k) STATEMENT
DEVICE: OX-SOX, MODEL C, D, E,
PATTIENT SAFETY INNOVATIONS, LLP 510(k) NO: K062300(TRADITIONAL)
ATTN: ERIK STALHANDSKE PHONE NO : 734-433-9498
10051 E HIGHLAND RD SE DECISION MADE: 27-NOV-06
SUITE 29-202 510(k) STATEMENT
HOWELL, MI 48843-6317
DEVICE: M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE J.00 (FOR
PHILIPS MEDICAL SYSTEMS 510(k) NO: K062271(SPECIAL)
ATTN: DAVID OSBORN PHONE NO : 978-659-3178
3000 MINUTEMAN RD. SE DECISION MADE: 30-NOV-06
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191
PHILIPS MEDICAL SYSTEMS 510(k) NO: K062455(SPECIAL)
ATTN: RICH MCCLEARY PHONE NO : 978-659-4914
3000 MINUTEMAN RD. SE DECISION MADE: 03-NOV-06
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T
PHILIPS MEDICAL SYSTEMS 510(k) NO: K062605(SPECIAL)
ATTN: RICH MCCLEARY PHONE NO : 978-659-4914
3000 MINUTEMAN RD. SE DECISION MADE: 09-NOV-06
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEARTSTART MRX MONITOR/DEFIBRILLATOR
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K062233(SPECIAL)
ATTN: MICHAEL J DOYLE PHONE NO : 978-659-3198
3000 MINUTEMAN ROAD SE DECISION MADE: 22-NOV-06
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTELLIVUE PATIENT MONITORS, MODELS MP20, MP30, MP40, MP50, MP60
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K063315(SPECIAL)
ATTN: ANDREAS SUCHI PHONE NO : 49 703 14631291
HEWLETT-PACKARD STR.2 SE DECISION MADE: 20-NOV-06
BOEBLINGEN, GERMANY D 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAAS QCA 3D
PIE MEDICAL IMAGING B.V. 510(k) NO: K063344(SPECIAL)
ATTN: CARLA DE VRIES PHONE NO : 31 43 3281322
BECANUSSTRAAT 13 D SE DECISION MADE: 28-NOV-06
MAASTRICHT, NETHERLANDS 6216 BX 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLY-CHEM CREATININE
POLYMEDCO, INC. 510(k) NO: K061944(TRADITIONAL)
ATTN: HELEN LANDICHO PHONE NO : 206-262-7363
510 FURNACE DOCK RD. SE DECISION MADE: 03-NOV-06
CORTLANDT MANOR, NY 10567 510(k) STATEMENT
DEVICE: DIGITAL MXR-D FLOWMETER
PORTER INSTRUMENT CO., INC. 510(k) NO: K062155(TRADITIONAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 919-859-4207
49 PLAIN STREET SE DECISION MADE: 09-NOV-06
NORTH ATTLRBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIO
POSSIS MEDICAL, INC. 510(k) NO: K061951(TRADITIONAL)
ATTN: FRANK B FREEDMAN PHONE NO : 763-780-4555
9055 EVERGREEN BLVD., N.W. SE DECISION MADE: 22-NOV-06
MINNEAPOLIS, MN 55433-8003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NATURAL ORIFICE LINEAR CUTTER DIGITAL LOADING UNITS
POWER MEDICAL INTERVENTIONS, INC. 510(k) NO: K063075(SPECIAL)
ATTN: BARBARA J WHITMAN PHONE NO : 267-775-8151
2021 CABOT BLVD. SE DECISION MADE: 02-NOV-06
LANGHORNE, PA 19047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENAMEL PRO
PREMIER DENTAL PRODUCTS CO. 510(k) NO: K062166(TRADITIONAL)
ATTN: VINCE D'ALESSANDRO PHONE NO : 610-239-6000
1710 ROMANO DR. SE DECISION MADE: 21-NOV-06
PLYMOUTH MEETING, PA 19462 510(k) STATEMENT
DEVICE: ENAMEL PRO VARNISH
PREMIER DENTAL PRODUCTS CO. 510(k) NO: K062683(TRADITIONAL)
ATTN: VINCE D'ALESSANDRO PHONE NO : 610-239-6000
1710 ROMANO DR. SE DECISION MADE: 21-NOV-06
PLYMOUTH MEETING, PA 19462 510(k) STATEMENT
DEVICE: GO GO ELITE TRAVELLER PLUS 4 WHEEL SCOOTER, MODEL SC54
PRIDE MOBILITY PRODUCTS CORP. 510(k) NO: K063389(SPECIAL)
ATTN: THOMAS SCHAPPERT PHONE NO : 570-655-5574
182 SUSQUEHANNA AVE. SE DECISION MADE: 17-NOV-06
EXETER, PA 18643 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NE
PRIME HERBS CORPORATION 510(k) NO: K061517(TRADITIONAL)
ATTN: GENEVIEVE HSIA PHONE NO : 408-744-1077
754 SAN ALESO AVE. SE DECISION MADE: 22-NOV-06
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAM
PROCTER & GAMBLE CO. 510(k) NO: K062638(TRADITIONAL)
ATTN: MARK M ANDERSON PHONE NO : 513-634-5196
6110 CENTER HILL AVE. SE DECISION MADE: 22-NOV-06
CINCINNATI, OH 45224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LA
PT. HALONI JANE 510(k) NO: K062955(TRADITIONAL)
ATTN: EMMY TJOENG PHONE NO : 909-591-8855
5445 DANIELS ST. SE DECISION MADE: 09-NOV-06
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSTOUCH POWDER FREE EXAMINATION GLOVES, NON STERILE
PT. MAHAKARYA INTI BUANA 510(k) NO: K061233(TRADITIONAL)
ATTN: V NADARAJAN PHONE NO : 626 179 44880
J1. SEI BELUMAI, DESA DALU 10 SE DECISION MADE: 03-NOV-06
A DUSUN I NO. 18, TANJUNG 510(k) STATEMENT
MORAWA, SUMUT, INDONESIA 20362
DEVICE: SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON S
PT. MAHAKARYA INTI BUANA 510(k) NO: K062313(TRADITIONAL)
ATTN: VENUGOPAL NADARAJAN PHONE NO : 62 61 7944880
J1. SEI BELUMAI SE DECISION MADE: 30-NOV-06
DESA DALU 10 A DUSUN I 510(k) STATEMENT
TANJUNG MORAWA, SUMUT, INDONESIA 20362
DEVICE: PTW DAVID IMRT QC VERIFICATION SYSTEM
PTW-NEW YORK CORP. 510(k) NO: K062817(TRADITIONAL)
ATTN: RICHARD D BARKER PHONE NO : 516-827-3181
205 PARK AVE. SE DECISION MADE: 22-NOV-06
HICKSVILLE, NY 11801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RII INFRARED EAR THERMOMETER, MODELS TH5XY SERIES
RADIANT INNOVATION, INC. 510(k) NO: K063185(SPECIAL)
ATTN: FRANK LIN PHONE NO : 886 361 11666
1F,NO. 3,INDUSTRIAL E. 9TH RD SE DECISION MADE: 17-NOV-06
SCIENCE-BASED INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
HSINCHU, CHINA (TAIWAN) 300
DEVICE: RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A
RF SURGICAL SYSTEMS, INC. 510(k) NO: K062642(TRADITIONAL)
ATTN: KEVIN COSENS PHONE NO : 425-283-0670
2700 RICHARDS ROAD SUITE 204 SE DECISION MADE: 02-NOV-06
BELLEVUE, WA 98005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNIPICC P.I.
RITA MEDICAL SYSTEMS, INC. 510(k) NO: K062579(TRADITIONAL)
ATTN: DAVID SMITH PHONE NO : 706-846-3126
ONE HORIZON WAY SE DECISION MADE: 28-NOV-06
MANCHESTER, GA 31816 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE
ROCKWELL MEDICAL TECHNOLOGIES, INC510(k) NO: K062399(TRADITIONAL)
ATTN: ROB CHIOINI PHONE NO : 248-960-9009
30142 WIXOM RD. SE DECISION MADE: 17-NOV-06
WIXOM, MI 48393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIERRA
SEASPINE, INC. 510(k) NO: K062934(TRADITIONAL)
ATTN: DIANA SMITH PHONE NO : 760-727-8399
2302 LA MIRADA DR. SE DECISION MADE: 16-NOV-06
VISTA, CA 92081-7862 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SECTRA WORKSTATION, VERSION 11.1
SECTRA IMTEC AB 510(k) NO: K063093(SPECIAL)
ATTN: CARL ALLETTO PHONE NO : 214-262-4209
1600 MANCHESTER WAY SE DECISION MADE: 07-NOV-06
CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEFINIUM 5000 X-RAY SYSTEM
SEDECAL S.A. 510(k) NO: K063283(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
PO BOX 7007 SE DECISION MADE: 17-NOV-06
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSACARE SAW-102 WRIST DIGITAL BLOOD PRESSURE MONITOR
SENSACARE LTD. 510(k) NO: K061935(TRADITIONAL)
ATTN: STEVEN CHANG PHONE NO : 02 879 71943
2F, NO. 13, LANE 28, SEC. 1 SE DECISION MADE: 08-NOV-06
HUANSHAN RD. 510(k) SUMMARY AVAILABLE FROM FDA
NEI HU, TAIPEI, CHINA (TAIWAN) 114THIRD PARTY REVIEW
DEVICE: SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES
SHANGHAI DENTAL INSTRUMENT FACTORY510(k) NO: K063302(TRADITIONAL)
ATTN: MARK JOB PHONE NO : 678-908-8180
REGULATORY TECHNOLOGY SERVICES SE DECISION MADE: 15-NOV-06
1394 25TH STREET, NW 510(k) SUMMARY AVAILABLE FROM FDA
BUFFALO, MN 55313 THIRD PARTY REVIEW
DEVICE: FLEX LOOP COIL SET 3T
SIEMENS AG 510(k) NO: K063373(TRADITIONAL)
ATTN: RUTH SCHNEISS PHONE NO : 49 913 1847445
HENKESTRASSE 127 SE DECISION MADE: 17-NOV-06
ERLANGEN, GERMANY D-91052 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SYNGO NEURO PBV CT
SIEMENS AG 510(k) NO: K063507(TRADITIONAL)
ATTN: RALF HOFMANN PHONE NO : 49 919 1188170
SIEMENSSTR. 1 SE DECISION MADE: 30-NOV-06
FORCHHEIM, GERMANY D-91301 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K063085(SPECIAL)
ATTN: SHEILA W PICKERING PHONE NO : 650-943-7187
1230 SHOREBIRD WAY SE DECISION MADE: 14-NOV-06
P O BOX 7393 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94039-7393
DEVICE: MODIFICATION TO ACUSON ANTARES ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K063138(SPECIAL)
ATTN: SHEILA W PICKERING PH.D. PHONE NO : 650-943-7187
1230 SHOREBIRD WAY SE DECISION MADE: 22-NOV-06
P O BOX 7393 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94039-7393
DEVICE: MAGNETOM SYSTEMS - I-CLASS AND T-CLASS RELEASES
SIEMENS MEDICAL SOLUTIONS, INC. 510(k) NO: K062454(TRADITIONAL)
ATTN: JUDITH CAMPBELL PHONE NO : 610-448-4918
51 VALLEY STREAM PARKWAY SE DECISION MADE: 03-NOV-06
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SBI LATERAL RHEAD IMPLANT
SMALL BONE INNOVATIONS INC. 510(k) NO: K062898(TRADITIONAL)
ATTN: ROBERT HOEHN PHONE NO : 215-428-1791
505 PARK AVE., 14TH FLOOR SE DECISION MADE: 13-NOV-06
NEW YORK, NY 10022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW RF CANNULAE
SMITH & NEPHEW, INC. 510(k) NO: K063467(SPECIAL)
ATTN: MINNIE MILDWOFF PHONE NO : 978-749-1538
150 MINUTEMAN RD. SE DECISION MADE: 21-NOV-06
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE
SMITHS MEDICAL MD, INC. 510(k) NO: K062323(SPECIAL)
ATTN: DAVID H SHORT PHONE NO : 651-628-7240
1265 GREY FOX RD. SE DECISION MADE: 01-NOV-06
ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE
SMITHS MEDICAL MD, INC. 510(k) NO: K062592(TRADITIONAL)
ATTN: MELANIE HESS PHONE NO : 651-633-2556
1265 GREY FOX RD. SE DECISION MADE: 29-NOV-06
ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RIVA BOND LC
SOUTHERN DENTAL INDUSTRIES, INC. 510(k) NO: K062064(TRADITIONAL)
ATTN: RAY CAHILL PHONE NO : 630-238-8300
729 N. ROUTE 83, SUITE 315 SE DECISION MADE: 09-NOV-06
BENSENVILLE, IL 60106 510(k) STATEMENT
DEVICE: RIVA LUTING PLUS
SOUTHERN DENTAL INDUSTRIES, INC. 510(k) NO: K062065(TRADITIONAL)
ATTN: RAY CAHILL PHONE NO : 630-238-8300
729 N. ROUTE 83, SUITE 315 SE DECISION MADE: 15-NOV-06
BENSENVILLE, IL 60106 510(k) STATEMENT
DEVICE: MALE REMEEX SYSTEM
SPECIALITIES REMEEX INTERNATIONAL,510(k) NO: K062341(TRADITIONAL)
ATTN: JEFFREY R SHIDEMAN PHONE NO : 952-835-4018
7307 GLOUCHESTER DRIVE SE DECISION MADE: 02-NOV-06
EDINA, MN 55435 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECTRAL WEST NILE VIRUS IGM STATUS TEST
SPECTRAL DIAGNOSTICS, INC. 510(k) NO: K052519(TRADITIONAL)
ATTN: NISAR A SHAIKH PHONE NO : 416 626 3233
135-2 THE WEST MALL SE DECISION MADE: 30-NOV-06
TORONTO, ONTARIO, CANADA M9C 1C2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REGEN BIOCEMENT
STEINER LABORATORIES 510(k) NO: K063010(TRADITIONAL)
ATTN: GREGORY GENE STEINER PHONE NO : 808-341-1725
590 FARRINGTON HWY. SE DECISION MADE: 28-NOV-06
#524 SUITE 132 510(k) STATEMENT
KAPOLEI, HI 96707
DEVICE: ISITE PACS, V 4. X
STENTOR INC., A PHILIPS MEDICAL SY510(k) NO: K063267(TRADITIONAL)
ATTN: DEANA WISEMAN PHONE NO : 650-228-5402
5000 MARINA BLVD. SE DECISION MADE: 09-NOV-06
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
BRISBANE, CA 94005 THIRD PARTY REVIEW
DEVICE: STIMUPLEX PEN
STOCKERT GMBH 510(k) NO: K061983(ABBREVIATED)
ATTN: DOMINIKA SCHULER PHONE NO : 49 761 207160
BOETZINGER STRASSE 72 SE DECISION MADE: 21-NOV-06
FREIBURG, B-W, GERMANY D-79111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIUS SPINAL SYSTEM
STRYKER SPINE 510(k) NO: K062270(TRADITIONAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145
2 PEARL COURT SE DECISION MADE: 22-NOV-06
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROFILER 2
SUN NUCLEAR CORP. 510(k) NO: K063021(TRADITIONAL)
ATTN: NOEL DOWNEY PHONE NO : 321-259-6862
425-A PINEDA COURT SE DECISION MADE: 22-NOV-06
MELBOURNE, FL 32940 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)
SUQIAN GREEN GLOVE CO., LTD. 510(k) NO: K062884(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441
NO.209 BEI SI HUAN ZHONG RD. SE DECISION MADE: 09-NOV-06
RM.1606 BLDG.1 JIANXIANG YUAN 510(k) SUMMARY AVAILABLE FROM FDA
BEIJING, CHINA 100083
DEVICE: 66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ
SUZHOU 66 VISION TECH CO., LTD. 510(k) NO: K052599(TRADITIONAL)
ATTN: GONG BO PHONE NO : 862 164 957283
600/8/503 LIUZHOU ROAD SE DECISION MADE: 07-NOV-06
SHANGHAI, CHINA 200233 510(k) STATEMENT
DEVICE: MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY
SYMTIUM CORPORATION 510(k) NO: K062781(TRADITIONAL)
ATTN: SEAN COMER PHONE NO : 210-745-2065
11503 JONES MALTSBERGER SE DECISION MADE: 21-NOV-06
SUITE 710 510(k) SUMMARY AVAILABLE FROM FDA
SAN ANTONIO, TX 78216
DEVICE: CADI, VERSION 4
SYNCA MARKETING, INC. 510(k) NO: K062237(TRADITIONAL)
ATTN: STEPHANE ARSENAULT PHONE NO : 450 582 1093
337 MARION STREET SE DECISION MADE: 20-NOV-06
LE GARDEUR, QUEBEC, CANADA J5Z 4W8510(k) STATEMENT
DEVICE: SYNTHES ANTEGRA SYSTEM
SYNTHES SPINE CO.LP 510(k) NO: K063158(SPECIAL)
ATTN: SUSAN LEWANDOWSKI PHONE NO : 610-719-5733
1302 WRIGHTS LANE EAST SE DECISION MADE: 14-NOV-06
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEVER CHEK TD-4231 AND TD-4223 BLOOD GLUCOSE MONITORING SYSTEM
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K063212(SPECIAL)
ATTN: PI-SHIOU LI PHONE NO : 886 2 66358080
4F, 88, SEC.1, KWANG FU ROAD SE DECISION MADE: 22-NOV-06
SAN CHUNG, TAIPEI, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: HEM-O-LOK LIGATION CLIP
TELEFLEX MEDICAL 510(k) NO: K062914(TRADITIONAL)
ATTN: LORI HAYS PHONE NO : 847-572-8027
2345 WAUKEGAN ROAD SE DECISION MADE: 02-NOV-06
BANNOCKBURN, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENACORE SP02 SENSORS
TENACORE HOLDINGS, INC. 510(k) NO: K053420(TRADITIONAL)
ATTN: BRAND CASO PHONE NO : 714-444-4643
647 EAST YOUNG ST. SE DECISION MADE: 15-NOV-06
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K062597(SPECIAL)
ATTN: CHRISTINA L THOMAS PHONE NO : 734-741-6238
6200 JACKSON RD. SE DECISION MADE: 03-NOV-06
ANN ARBOR, MI 48103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT
THE BINDING SITE, LTD. 510(k) NO: K062183(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
2425 W. OLYMPIC BLV SE DECISION MADE: 21-NOV-06
SANTA MONICA, CA 90404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300
THUNDER TIGER CORP. 510(k) NO: K062812(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 3 5208829
58 FU-CHIUN STREET SE DECISION MADE: 28-NOV-06
HSIN CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST
TIANJIN NEW BAY BIORESEARCH CO., L510(k) NO: K061617(TRADITIONAL)
ATTN: RODRIGO BERTIE PHONE NO : 760-822-6517
3108 AVENIDA OLMEDA SE DECISION MADE: 22-NOV-06
CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LITHOGOLD
TISSUE REGENERATION TECHNOLOGIES, 510(k) NO: K062081(TRADITIONAL)
ATTN: CHERITA JAMES PHONE NO : 202-546-1262
719 A ST., NE SE DECISION MADE: 02-NOV-06
WASHINGTON, DC 20002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SALTO TALARIS TOTAL ANKLE PROSTHESIS
TORNIER 510(k) NO: K060544(TRADITIONAL)
ATTN: MIREILLE EMERY PHONE NO : 003 347 6613898
RUE DOYEN GOSSE SE DECISION MADE: 13-NOV-06
ST. ISMIER, FRANCE 38330 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEQUALIS SHOULDER SYSTEM
TORNIER 510(k) NO: K063081(SPECIAL)
ATTN: MIREILLE LEMERY PHONE NO : 003 347 6613898
161 RUE LAVOISIER SE DECISION MADE: 09-NOV-06
MONTBONNOT, SAINT-ISMIER, FRANCE 3510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL CVV-001A VESSEL VIEW SOFTWARE OPTION
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K063184(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 03-NOV-06
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: TSX-301A, AQUILION ONE CT SYSTEM
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K063189(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 03-NOV-06
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: CSTC-002A, EXTENDED FIELD OF VIEW SOFTWARE OPTION
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K063241(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 09-NOV-06
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: EXCELART VANTAGE ATLAS, MODEL MRT-1503
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K063361(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 21-NOV-06
TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K063130(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DRIVE SE DECISION MADE: 02-NOV-06
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781 THIRD PARTY REVIEW
DEVICE: 21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2118A (ME355I2)
TOTOKU ELECTRIC CO., LTD 510(k) NO: K063197(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 81 268 345469
300 OYA SE DECISION MADE: 30-NOV-06
UEDA, NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 21.3-INCH (54CM) MONOCHROME LCD MONITOR MDL2121A (ME253I2)
TOTOKU ELECTRIC CO., LTD 510(k) NO: K063198(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 81 268 345469
300 OYA SE DECISION MADE: 30-NOV-06
UEDA, NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K062816(TRADITIONAL)
ATTN: CYNTHIA KNAPP PHONE NO : 800-871-8909
982 KEYNOTE CIRCLE SUITE 6 SE DECISION MADE: 01-NOV-06
CLEVELAND, OH 44131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K062839(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-871-8909
982 KEYNOTE CIRCLE SUITE 6 SE DECISION MADE: 09-NOV-06
CLEVELAND, OH 44131 510(k) STATEMENT
DEVICE: TRU-MR LARYNGOSCOPE SET
TRUPHATEK INTERNATIONAL, LTD. 510(k) NO: K062523(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
3460 POINTE CREEK CT. SE DECISION MADE: 17-NOV-06
# 102 510(k) SUMMARY AVAILABLE FROM FDA
BONITA SPRINGS, FL 34134
DEVICE: MAXIMA ANTERIOR CERVICAL PLATE SYSTEM
U&I CORP. 510(k) NO: K061002(TRADITIONAL)
ATTN: BETTY LIM PHONE NO : 823 185 20102 X302
529-1 YONGHYUN-DONG SE DECISION MADE: 15-NOV-06
EUIJUNGBU, KYUNGGI-DO, REPUBLIC OF510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE BLACK LATEX EXAMINATION GLOVE WITH PROTEIN LABELING
UG HEALTHCARE (USA), INC. 510(k) NO: K062688(TRADITIONAL)
ATTN: KENNETH J STANTON PHONE NO : 310-328-7981
2420 CARSON ST., SUITE 125 SE DECISION MADE: 30-NOV-06
TORRANCE, CA 90501-3163 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTICARE DISPOSABLE SYRINGES AND NEEDLES
ULTIMED, INC. 510(k) NO: K062702(TRADITIONAL)
ATTN: CAROLE STAMP PHONE NO : 952-746-8080
5353 WAYZATA BLVD. SE DECISION MADE: 29-NOV-06
SUITE 505 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55416-1334
DEVICE: AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER
UNITED STATES SURGICAL, A DIVISION510(k) NO: K061288(SPECIAL)
ATTN: FRANK GIANELLI PHONE NO : 203-492-5352
150 GLOVER AVE. SE DECISION MADE: 02-NOV-06
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGASURE ADVANCE LAPAROSCOPIC SEALER/DIVIDER WITH DISSECTING ELE
VALLEYLAB 510(k) NO: K063195(TRADITIONAL)
ATTN: CHARLES COPPERBERG PHONE NO : 303-530-6247
5920 LONGBOW DR. SE DECISION MADE: 29-NOV-06
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADJUST-RIGHT FIXATION DEVICES
VALPO ORTHOPEDIC TECHNOLOGY, INC. 510(k) NO: K062734(TRADITIONAL)
ATTN: RON CLARK PHONE NO : 219-395-4964
4805 LAKERIDGE CT. SE DECISION MADE: 22-NOV-06
VALPARAISO, IN 46383 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7500
VASCULAR SOLUTIONS, INC. 510(k) NO: K062822(TRADITIONAL)
ATTN: PATRICE STROMBERG PHONE NO : 763-656-4300
6464 SYCAMORE COURT NORTH SE DECISION MADE: 21-NOV-06
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONARA; SONARA/TEK
VIASYS HEALTHCARE, INC. 510(k) NO: K060421(TRADITIONAL)
ATTN: GLEN HERMANSON PHONE NO : 608-441-2065
227 WASHINGTON ST. ' SE DECISION MADE: 03-NOV-06
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
CONSHOHOCKEN, PA 19428
DEVICE: NICOLETONE SYSTEM V32 AMPLIFIER
VIASYS NEUROCARE 510(k) NO: K061908(ABBREVIATED)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LANE SE DECISION MADE: 06-NOV-06
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HUMERAL HEAD, MANUAL DRIVER
VIDACARE CORPORATION 510(k) NO: K062422(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 07-NOV-06
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERED EZ-IO BONE MARROW ASPIRATION SYSTEM
VIDACARE CORPORATION 510(k) NO: K062833(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 30-NOV-06
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRANDIO FLOW TRY-IN
VOCO GMBH 510(k) NO: K062343(TRADITIONAL)
ATTN: MICHAEL SUES PHONE NO : 49 472 1719214
ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 02-NOV-06
CUXHAVEN, GERMANY D-27472 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEPATOSTAT SET, MODEL 760X
VYGON CORP. 510(k) NO: K061796(TRADITIONAL)
ATTN: STEPHEN GOLDNER PHONE NO : 248-855-5595
30833 NORTHWESTERS HWY SE DECISION MADE: 02-NOV-06
SUITE 121 510(k) SUMMARY AVAILABLE FROM FDA
FARMINGTON HILLS, MI 48334
DEVICE: GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL
W. L. GORE & ASSOCIATES, INC. 510(k) NO: K063435(SPECIAL)
ATTN: MICHAEL IVEY PHONE NO : 928-864-3790
3450 WEST KILTIE LN. SE DECISION MADE: 28-NOV-06
FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GORE PROPATEN VASCULAR GRAFT
W.L. GORE & ASSOCIATES,INC 510(k) NO: K062161(TRADITIONAL)
ATTN: MICHAEL IVEY PHONE NO : 928-864-3600
1505 NORTH FOURTH ST. SE DECISION MADE: 09-NOV-06
FLAGSTAFF, AZ 86003-3000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILE POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRAC
WEAR SAFE MALAYSIA SDN. BHD. 510(k) NO: K062917(TRADITIONAL)
ATTN: TK LOH PHONE NO : 603 317 63525
LOT 1, LEBOH HISHAMUDDIN SATU, SE DECISION MADE: 02-NOV-06
NORTH KLANG STRAITS IND. AREA 510(k) STATEMENT
PORT KLANG, SELANGOR, D.E., MALAYSIA 42000
DEVICE: SOYALA FULL FACE MASK
WEINMANN GERATE FUR MEDIZIN GMBH +510(k) NO: K061653(TRADITIONAL)
ATTN: ECKHARDT ABERS PHONE NO : 011 49 4054702180
KRONSAALSWEG 40 SE DECISION MADE: 09-NOV-06
HAMBURG, GERMANY 22525 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XERON PACS
XERON HEALTHCARE CORP. 510(k) NO: K062757(TRADITIONAL)
ATTN: MELISSA MAHALL PHONE NO : 301-829-2468
6403 BELMONT CIRCLE SE DECISION MADE: 07-NOV-06
BUILDING 2 510(k) SUMMARY AVAILABLE FROM FDA
MOUNT AIRY, MD 21771
DEVICE: ZIMMER HIP COMPUTER ASSISTED SOLUTIONS ELECTROMAGNETIC AND IMAGE
ZIMMER, INC. 510(k) NO: K062228(TRADITIONAL)
ATTN: PATRICIA JENKS PHONE NO : 574-371-8354
P.O. BOX 708 SE DECISION MADE: 08-NOV-06
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIVERSAL LOCKING SYSTEM, 2.7MM PLATES & SCREWS
ZIMMER, INC. 510(k) NO: K063303(SPECIAL)
ATTN: ANTHONY FRANCALANCIA PHONE NO : 574-372-4570
P.O. BOX 708 SE DECISION MADE: 22-NOV-06
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 262
TOTAL WITH SUMMARIES 232
TOTAL WITH STATEMENTS 30
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