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