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510(k)s Final Decisions Rendered for November 2002 |
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SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-NOV-2002 THROUGH 30-NOV-2002
DEVICE: ALLGRAD WASH (HERPES BUFFERED WASHING MEDIUM)
INTL., INC. 510(k) NO: K023033(TRADITIONAL)
ATTN: MICHAEL D CECCHI PHONE NO : 203-453-1700
393 SOUNDVIEW ROAD SE DECISION MADE: 26-NOV-02
GUILFORD, CT 06443 510(k) STATEMENT
DEVICE: MICROHYBRID 11
AB ARDENT 510(k) NO: K022971(TRADITIONAL)
ATTN: CLYDE E INGERSOLL PHONE NO : 716-693-6591
54 RIVERVIEW AVE SE DECISION MADE: 25-NOV-02
TONAWANDA, NY 14150-5260 510(k) STATEMENT
DEVICE: MICROFILL 13
AB ARDENT 510(k) NO: K022972(TRADITIONAL)
ATTN: CLYDE E INGERSOLL PHONE NO : 716-693-6591
54 RIVERVIEW AVENUE SE DECISION MADE: 22-NOV-02
TONAWANDA, NY 14150-5260 510(k) STATEMENT
DEVICE: ADHESIVE 14
AB ARDENT 510(k) NO: K022973(TRADITIONAL)
ATTN: CLYDE E INGERSOLL PHONE NO : 716-693-6591
54 RIVERVIEW AVE SE DECISION MADE: 22-NOV-02
TONAWANDA, NY 14150-5260 510(k) STATEMENT
DEVICE: MICROHYBRID 12
AB ARDENT 510(k) NO: K022974(TRADITIONAL)
ATTN: CLYDE E INGERSOLL PHONE NO : 716-693-6591
54 RIVERVIEW AVE SE DECISION MADE: 22-NOV-02
TONAWANDA, NY 14150-5260 510(k) STATEMENT
DEVICE: ETCHING 15
AB ARDENT 510(k) NO: K022975(TRADITIONAL)
ATTN: CLYDE E INGERSOLL PHONE NO : 716-693-6591
54 RIVERVIEW AVE SE DECISION MADE: 22-NOV-02
TONAWANDA, NY 14150-5260 510(k) STATEMENT
DEVICE: KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
ACUSON CORP. 510(k) NO: K023772(TRADITIONAL)
ATTN: BOB LEIKER PHONE NO : 650-694-5080
1230 SHOREBIRD WAY SE DECISION MADE: 22-NOV-02
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPE
ACUTE IDEAS CO. LTD. 510(k) NO: K023711(TRADITIONAL)
ATTN: ALBERT CHEN PHONE NO : 886 287 514868
3F,NO.11,LANE 35, JIHU ROAD SE DECISION MADE: 21-NOV-02
NEIHU DIST., 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI, CHINA (TAIWAN) 114
DEVICE: CALGITROL AG SILVER ALGINATE WOUND DRESSING
ADRI 510(k) NO: K011618(TRADITIONAL)
ATTN: GEORGE H SCHERR PHONE NO : 708-747-3717
P.O. BOX 134 SE DECISION MADE: 15-NOV-02
PARK FOREST, IL 60466 510(k) STATEMENT
DEVICE: HEARTONE EVENT RECORDER AND TRANSMITTER
AEROTEL MEDICAL SYSTEMS (1998) LTD510(k) NO: K023418(SPECIAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 SE DECISION MADE: 06-NOV-02
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLUMBUS TOTAL KNEE SYSTEM (CR)
AESCULAP, INC. 510(k) NO: K022672(TRADITIONAL)
ATTN: JOYCE KILROY PHONE NO : 610-791-6882
3773 CORPORATE PKWY. SE DECISION MADE: 08-NOV-02
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST
ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K022501(ABBREVIATED)
ATTN: NAISHU WANG PHONE NO : 858-513-3888
12330 STOWE DRIVE SE DECISION MADE: 13-NOV-02
POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTANT-VIEW LH OVULATION PREDICTING TEST
ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K022829(ABBREVIATED)
ATTN: NAISHU WANG PHONE NO : 858-513-3888
12330 STOWE DRIVE SE DECISION MADE: 05-NOV-02
POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST
ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K022915(TRADITIONAL)
ATTN: NAISHU WANG PHONE NO : 858-513-3888
12330 STOWE DRIVE SE DECISION MADE: 29-NOV-02
POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRAPES WITH ABSORBENT REINFORCEMENT
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K023425(SPECIAL)
ATTN: SHARON NICHOLS PHONE NO : 847-785-3311
1500 WAUKEGAN RD. BLDG. WM SE DECISION MADE: 06-NOV-02
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED USED DISPOSABLE TROCARS
ALLIANCE MEDICAL CORP. 510(k) NO: K023191(TRADITIONAL)
ATTN: MARK ALDANA PHONE NO : 806-745-7718
1001 SLATON HWY. SE DECISION MADE: 22-NOV-02
LUBBOCK, TX 79404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMEDICA DRUG SCREEN COCAINE TEST
AMEDICA BIOTECH, INC. 510(k) NO: K022954(TRADITIONAL)
ATTN: JEFF CHEN PHONE NO : 510-785-5980
28301 INDUSTRIAL BLVD SUITE K SE DECISION MADE: 06-NOV-02
HAYWARD, CA 94545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMEDICA DRUG SCREEN THC TEST
AMEDICA BIOTECH, INC. 510(k) NO: K022955(TRADITIONAL)
ATTN: JEFF CHEN PHONE NO : 510-785-5980
28301 INDUSTRIAL BLVD SUITE K SE DECISION MADE: 06-NOV-02
HAYWARD, CA 94545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMEDICA DRUG SCREEN OPIATES TEST
AMEDICA BIOTECH, INC. 510(k) NO: K023047(TRADITIONAL)
ATTN: JEFF CHEN PHONE NO : 510-785-5980
28301 INDUSTRIAL BLVD SUITE K SE DECISION MADE: 06-NOV-02
HAYWARD, CA 94545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENTED CEMENT RESTRICTOR
AMEDICA CORP. 510(k) NO: K022729(TRADITIONAL)
ATTN: ASHOK C KHANDKAR PHONE NO : 801-231-5729
2116 SOUTH LAKELINE DR. SE DECISION MADE: 14-NOV-02
SALT LAKE CITY, UT 84109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMEDITECH IMMUTEST HCG PREGANCY TEST
AMEDITECH, INC. 510(k) NO: K023126(TRADITIONAL)
ATTN: JOHN WU PHONE NO : 858-535-1968
10340 CAMINO SANTA FE, SUITE F SE DECISION MADE: 18-NOV-02
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: MONARC SLING SYSTEM
AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K023516(SPECIAL)
ATTN: DAVID WORRELL PHONE NO : 952-930-6314
10700 BREN RD., WEST SE DECISION MADE: 19-NOV-02
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMICAS LIGHT BEAM WORKSTATION, MODEL 1.0
AMICAS, INC. 510(k) NO: K022970(TRADITIONAL)
ATTN: PATRICE NEDELEC PHONE NO : 617-779-7878
20 GUEST STREET SE DECISION MADE: 22-NOV-02
BRIGHTON, MA 02135 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRO-TOUCH NEXT STEP POWDER FREE MEDICAL EXAMINATION GLOVES WIT
ANSELL HEALTHCARE PRODUCTS, INC. 510(k) NO: K023153(SPECIAL)
ATTN: JAMES R CHATTERTON PHONE NO : 330-833-2811
1875 HARSH AVENUE, S.E. SE DECISION MADE: 13-NOV-02
MASSILLON, OH 44646-7199 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITRI GRIP POWDERED NITRILE EXAMINATION GLOVES
AR ALLIANCE HEALTHCARE SDN. BHD. 510(k) NO: K022572(TRADITIONAL)
ATTN: CHUA C CHUAN PHONE NO : 600 459 37616
8, LORONG IND. 11, KAWASAN SE DECISION MADE: 08-NOV-02
PERINDUSTRIAN BUKIT PANCHOR, 510(k) SUMMARY AVAILABLE FROM FDA
NIBONG TEBAL, PULAU PINANG, MALAYSIA 14300
DEVICE: ARTHREX FIBERWIRE IN USP SIZES
ARTHREX, INC. 510(k) NO: K021434(TRADITIONAL)
ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553
2885 SOUTH HORSESHOE DR. SE DECISION MADE: 07-NOV-02
NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASCENSION SILLICONE MCP
ASCENSION ORTHOPEDICS, INC. 510(k) NO: K022892(TRADITIONAL)
ATTN: ROBERT M WOLFARTH PHONE NO : 512-836-5001
8200 CAMERON RD., SUITE C-140 SE DECISION MADE: 25-NOV-02
AUSTIN, TX 78754-3832 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASSUFIL
ASSUT EUROPE S.P.A. 510(k) NO: K021767(TRADITIONAL)
ATTN: LUCIO IMPROTA PHONE NO : 561-477-1671
10147 UMBERLAND PLACE SE DECISION MADE: 19-NOV-02
BOCA RATON, FL 33428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTS
ASTRA TECH, INC. 510(k) NO: K023631(SPECIAL)
ATTN: BRUCE R MANNING PHONE NO : 508-393-3100
96 WEST MAIN STREET SE DECISION MADE: 07-NOV-02
P.O. BOX 809 510(k) SUMMARY AVAILABLE FROM FDA
NORTHBOROUGH, MA 01532
DEVICE: MODIFICATION TO RADIAL HEAD IMPLANT
AVANTA ORTHOPAEDICS, INC. 510(k) NO: K023604(SPECIAL)
ATTN: LOUISE FOCHT PHONE NO : 858-452-8580
9369 CARROLL PARK DRIVE SE DECISION MADE: 27-NOV-02
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92121
DEVICE: AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK)
AZOG, INC. 510(k) NO: K022680(TRADITIONAL)
ATTN: AZUBUIKE OGALA PHONE NO : 908-213-2900
1011 US HWY 22 SE DECISION MADE: 01-NOV-02
PHILLIPSBURG, NJ 08865 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST (DEVICE OR CASSETTE
AZOG, INC. 510(k) NO: K022681(TRADITIONAL)
ATTN: AZUBUIKE OGALA PHONE NO : 908-213-2900
1011 US HWY 22 SE DECISION MADE: 01-NOV-02
PHILLIPSBURG, NJ 08865 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRASOUND SCANNER, TYPE 1101
B-K MEDICAL A/S 510(k) NO: K023457(TRADITIONAL)
ATTN: VILLY BRAENDER PHONE NO : 011 454 4528100
MILEPARKEN 34 SE DECISION MADE: 01-NOV-02
HERLEV, DENMARK DK-2730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MILLENNIUM MICROSURGICAL SYSTEM
BAUSCH & LOMB, INC. 510(k) NO: K022760(TRADITIONAL)
ATTN: DENNIS POZZO PHONE NO : 636-226-3183
3365 TREE CT. INDUSTRIAL BLVD. SE DECISION MADE: 18-NOV-02
ST. LOUIS, MO 63122-6694 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAXTER ACCURA SYSTEM, MODEL 5M5660
BAXTER HEALTHCARE CORP. 510(k) NO: K021615(TRADITIONAL)
ATTN: DAVID E CURTIN PHONE NO : 847-473-6079
1620 WAUKEGAN ROAD SE DECISION MADE: 18-NOV-02
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASCENSIA DEX 2 DIABETES CARE SYSTEM
BAYER CORP. 510(k) NO: K023584(SPECIAL)
ATTN: GEORGE M TANCROS PHONE NO : 574-262-6928
1884 MILES AVE. SE DECISION MADE: 20-NOV-02
P.O. BOX 70 510(k) SUMMARY AVAILABLE FROM FDA
ELKHART, IN 46515-0070
DEVICE: CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
BAYER DIAGNOSTICS CORP. 510(k) NO: K022178(TRADITIONAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE SE DECISION MADE: 12-NOV-02
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
BAYER DIAGNOSTICS CORP. 510(k) NO: K022329(TRADITIONAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE SE DECISION MADE: 27-NOV-02
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
BAYER DIAGNOSTICS CORP. 510(k) NO: K023184(TRADITIONAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE SE DECISION MADE: 18-NOV-02
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE
BD VACUTAINER SYSTEMS PREANALYICAL510(k) NO: K023075(TRADITIONAL)
ATTN: JING ZHANG PHONE NO : 201-847-4717
1 BECTON DRIVE, MCC 300 SE DECISION MADE: 25-NOV-02
FRANKLIN LAKES, NJ 07417-1885 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT
BECKMAN COULTER, INC. 510(k) NO: K023048(SPECIAL)
ATTN: ANNETTE HELLIE PHONE NO : 714-993-8767
200 SOUTH KRAEMER BLVD. SE DECISION MADE: 07-NOV-02
BREA, CA 92822 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCESS HYPERSENSITIVE HTSH ASSAY
BECKMAN COULTER, INC. 510(k) NO: K023093(TRADITIONAL)
ATTN: DENISE THOMPSON PHONE NO : 952-368-1202
1000 LAKE HAZELTINE DR. SE DECISION MADE: 25-NOV-02
CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
BECTON DICKINSON & CO. 510(k) NO: K023301(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 12-NOV-02
SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD VACUTAINER SST II PLUS TUBES
BECTON DICKINSON & CO. 510(k) NO: K023331(TRADITIONAL)
ATTN: JING ZHANG PHONE NO : 201-847-4717
1 BECTON DRIVE, MC 300 SE DECISION MADE: 25-NOV-02
FRANKLIN LAKES, NJ 07417-1880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMIKACIN-0.5-64 UG/ML
BECTON, DICKINSON AND COMPANY 510(k) NO: K023444(TRADITIONAL)
ATTN: BRADFORD SPRING PHONE NO : 410-316-4206
7 LOVETON CIR. SE DECISION MADE: 12-NOV-02
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CURAD
BEIERSDORF AG 510(k) NO: K022645(TRADITIONAL)
ATTN: DANIEL J DILLON PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 05-NOV-02
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASY LIFE
BERKLINE CORP. 510(k) NO: K023521(TRADITIONAL)
ATTN: DAVID POPKIN PHONE NO : 423-585-1500
ONE BERKLINE DRIVE SE DECISION MADE: 19-NOV-02
MORRISTOWN, TN 37813 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITALSAT SERIES
BETA BIOMED SERVICES, INC. 510(k) NO: K011518(TRADITIONAL)
ATTN: E J SMITH PHONE NO : 410-451-0639
1468 HARWELL AVE SE DECISION MADE: 15-NOV-02
CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOREAL 3D
BIO MEDI COM 510(k) NO: K023473(TRADITIONAL)
ATTN: COLLEEN DENSMORE PHONE NO : 317-849-1916
7992 CASTLEWAY DRIVE SE DECISION MADE: 20-NOV-02
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE
BIO PROTECH, INC. 510(k) NO: K020003(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 07-NOV-02
SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
BIOCOMPOSITES LTD. 510(k) NO: K021551(TRADITIONAL)
ATTN: J. STEPHEN BRATT PHONE NO : 441 782 206500
ETRUSCAN STREET SE DECISION MADE: 01-NOV-02
ETRURIA 510(k) SUMMARY AVAILABLE FROM FDA
STOKE ON TRENT, STAFFORDSHIRE, UNITED KINGDOM ST1 5PQ
DEVICE: ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS02-9
BIOMEDICAL LIFE SYSTEMS, INC. 510(k) NO: K022841(TRADITIONAL)
ATTN: RICHARD SAXON PHONE NO : 760-727-5600
P.O. BOX 1360 SE DECISION MADE: 19-NOV-02
VISTA, CA 92085-1360 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-10
BIOMEDICAL LIFE SYSTEMS, INC. 510(k) NO: K022925(TRADITIONAL)
ATTN: RICHARD SAXON PHONE NO : 760-727-5600
P.O. BOX 1360 SE DECISION MADE: 19-NOV-02
VISTA, CA 92085-1360 510(k) STATEMENT
DEVICE: ARCPM 1050 RESIN-HIPS
BIOMET ORTHOPEDICS, INC. 510(k) NO: K023357(SPECIAL)
ATTN: TRACY J BICKEL PHONE NO : 574-267-6639
56 EAS BELL DRIVE SE DECISION MADE: 06-NOV-02
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46582
DEVICE: HA X-SERIES BI-METRIC HIP FEMORAL COMPONENTS
BIOMET, INC. 510(k) NO: K023409(SPECIAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639
56 EAST BELL DRIVE SE DECISION MADE: 08-NOV-02
PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: CARDIOTOUCH-3000
BIONET COMPANY LTD 510(k) NO: K023034(SPECIAL)
ATTN: JAY MANSOUR PHONE NO : 678-908-8180
1308 MORNINGSIDE PARK DR. SE DECISION MADE: 14-NOV-02
ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION
BIONOSTICS, INC. 510(k) NO: K022769(TRADITIONAL)
ATTN: KATHLEEN STORRO PHONE NO : 978-772-7070
7 JACKSON ROAD SE DECISION MADE: 13-NOV-02
DEVENS, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE BIOPLATE BATTERY POWERED DRILL
BIOPLATE, INC. 510(k) NO: K022986(TRADITIONAL)
ATTN: BRUCE F MACKLER PHONE NO :
815 CONNECTICUT AVE NW SE DECISION MADE: 19-NOV-02
WASHINGTON, DC 20006-4004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAX
BIOPLATE, INC. 510(k) NO: K023665(SPECIAL)
ATTN: CAROL E JONES PHONE NO : 323-549-9500
6911 MELROSE AVE. SE DECISION MADE: 22-NOV-02
LOS ANGELES, CA 90038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTE
BIOSPHERE MEDICAL, INC. 510(k) NO: K021397(TRADITIONAL)
ATTN: SHIELA HEMEON-HEYER PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 22-NOV-02
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIRD AVEA VENTILATOR
BIRD PRODUCTS CORP. 510(k) NO: K022674(TRADITIONAL)
ATTN: JEFFREY K SHAPIRO PHONE NO : 202-637-5600
555 THIRTEENTH STREET, NW SE DECISION MADE: 06-NOV-02
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM
BLACKSTONE MEDICAL, INC. 510(k) NO: K023498(SPECIAL)
ATTN: DEAN E CIPORKIN PHONE NO : 413-731-8711
90 BROOKSDALE DR. SE DECISION MADE: 13-NOV-02
SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 804SIII; 804W; LIBRA TENS; 410; S-TENS II
BODY CLOCK HEALTH CARE LTD 510(k) NO: K021846(TRADITIONAL)
ATTN: JONATHAN BASH PHONE NO : 440 208 5329595
108 GEORGE LANE SE DECISION MADE: 22-NOV-02
LONDON, ENGLAND, UNITED KINGDOM E1510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V TENS PLUS
BODY CLOCK HEALTH CARE LTD 510(k) NO: K022731(TRADITIONAL)
ATTN: JONATHAN BASH PHONE NO : 44 20 85329595
108 GEORGE LANE SE DECISION MADE: 14-NOV-02
LONDON, ENGLAND, UNITED KINGDOM E1510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROVASIVE PULMONARY GUIDEWIRE
BOSTON SCIENTIFIC CORP. 510(k) NO: K022059(TRADITIONAL)
ATTN: JAMES D MCMAHON PHONE NO : 508-652-5566
ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 13-NOV-02
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00
BOSTON SCIENTIFIC CORP. 510(k) NO: K023337(TRADITIONAL)
ATTN: PAIGE SWEENEY PHONE NO : 508-652-5560
ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 18-NOV-02
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RENEGADE STC 18 MICROCATHETER
BOSTON SCIENTIFIC CORP. 510(k) NO: K023681(SPECIAL)
ATTN: CHRISTINE M CAMERON PHONE NO : 508-650-8471
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 26-NOV-02
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLANTIS PV IMAGING CATHETER, MODEL 36456
BOSTON SCIENTIFIC, TARGET 510(k) NO: K022860(SPECIAL)
ATTN: IRENE JAWORSKI PHONE NO : 510-440-7700
47900 BAYSIDE PARKWAY SE DECISION MADE: 21-NOV-02
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE
BOWEL MANAGEMENT SYSTEMS, LLC 510(k) NO: K023344(SPECIAL)
ATTN: CHAD A COBERLY PHONE NO : 904-261-2169
1886 SOUTH 14TH STREET SE DECISION MADE: 06-NOV-02
SUITE 6 510(k) SUMMARY AVAILABLE FROM FDA
FERNANDINA BEACH, FL 32034
DEVICE: RECOVERY FILTER SYSTEM, MODEL RF-048F
C.R. BARD, INC. 510(k) NO: K022236(SPECIAL)
ATTN: KAY FULLER PHONE NO : 480-303-2539
1625 WEST 3RD STREET SE DECISION MADE: 27-NOV-02
TEMPE, AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS
CANON U.S.A., INC. 510(k) NO: K023586(SPECIAL)
ATTN: SHIELA DRISCOLL PHONE NO : 516-328-5602
ONE CANON PLAZA SE DECISION MADE: 05-NOV-02
LAKE SUCCESS, NY 11042-1198 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G
CANON U.S.A., INC. 510(k) NO: K023750(TRADITIONAL)
ATTN: SHEILA DRISCOLL PHONE NO : 516-328-5602
ONE CANON PLAZA SE DECISION MADE: 22-NOV-02
LAKE SUCCESS, NY 11042-1198 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CANON FULL AUTO TONOMETER TX-F
CANON, INC.-UTSUNOMIYA OPTICAL PRO510(k) NO: K023816(TRADITIONAL)
ATTN: SHEILA DRISCOLL PHONE NO : 516-328-5602
ONE CANON PLAZA SE DECISION MADE: 26-NOV-02
LAKE SUCCESS, NY 11042-1198 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: QUANTIX/ND DEVICE
CARDIOSONIX, LTD. 510(k) NO: K023431(SPECIAL)
ATTN: AHAVA STEIN PHONE NO : 972 9 7670002
BEIT HAPA'AMON (BOX 124) SE DECISION MADE: 13-NOV-02
20 HATA'AS ST. 510(k) SUMMARY AVAILABLE FROM FDA
KFAR SABA, ISRAEL 44425
DEVICE: PHASEAL
CARMEL PHARMA AB. 510(k) NO: K023747(SPECIAL)
ATTN: KJELL ANDREASSON PHONE NO : 463 170 30400
BOX 5352 SE DECISION MADE: 15-NOV-02
GOTHENBURG, SWEDEN 40228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROMOTOR
CERES FERTILITY, INC. 510(k) NO: K023106(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 05-NOV-02
IRVINE, CA 92606 510(k) STATEMENT
DEVICE: AQUEOUS ACRYLIC DISPERSION 28% W/W
CHX TECHNOLOGIES, INC. 510(k) NO: K023671(SPECIAL)
ATTN: ROSS PERRY PHONE NO : 416 233 3737
4800 DUNDAS ST. WEST SUITE 105 SE DECISION MADE: 25-NOV-02
TORONTO, ONTARIO, CANADA M9A 1B1 510(k) STATEMENT
DEVICE: AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
CIBA VISION CORP. 510(k) NO: K022687(TRADITIONAL)
ATTN: STEVEN DOWDLEY PHONE NO : 687-415-3897
11460 JOHNS CREEK PKWY. SE DECISION MADE: 19-NOV-02
DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRI
CLARUS MEDICAL, LLC. 510(k) NO: K022610(TRADITIONAL)
ATTN: TOM BARTHEL PHONE NO : 763-525-8403
1000 BOONE AVE. NORTH SE DECISION MADE: 05-NOV-02
MINNEAPOLIS, MN 55427 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HERMES OPERATING ROOM CONTROL CENTER
COMPUTER MOTION, INC. 510(k) NO: K023095(SPECIAL)
ATTN: CATHY STUPAK PHONE NO : 805-685-3729
130 CREMONA DRIVE, SUITE B SE DECISION MADE: 15-NOV-02
GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
COOK, INC. 510(k) NO: K023504(SPECIAL)
ATTN: KAREN BRADBURN PHONE NO : 800-346-2686
750 DANIELS WAY SE DECISION MADE: 13-NOV-02
P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA
BLOOMINGTON, IN 47402-0489
DEVICE: CERVIVE ANTERIOR CERVICAL PLATING SYSTEM, MODEL NUMBER 157.XXX S
CORIN U.S.A. 510(k) NO: K022798(TRADITIONAL)
ATTN: JOEL K BATTS PHONE NO : 813-977-4469
10500 UNIVERSITY CENTER DR., SE DECISION MADE: 19-NOV-02
SUITE 190 510(k) SUMMARY AVAILABLE FROM FDA
TAMPA, FL 33612
DEVICE: COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE
COZART BIOSCIENCE LTD. 510(k) NO: K020920(TRADITIONAL)
ATTN: ROBERTO LIDDI PHONE NO : 440 123 5861483
45 MILTON PARK SE DECISION MADE: 05-NOV-02
ABINGDON 510(k) SUMMARY AVAILABLE FROM FDA
OXFORDSHIRE OX14 4RU, UNITED KINGDOM OX14 4RU
DEVICE: ECAT LSO PET/CT 16
CTI PET SYSTEMS, INC. 510(k) NO: K023518(SPECIAL)
ATTN: WILLIAM SKREMSKY PHONE NO : 865-218-2522
810 INNOVATION DR. SE DECISION MADE: 08-NOV-02
KNOXVILLE, TN 37932-2571 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECAT PET/CT; ECAT LSO PET/CT; ECAT LSO PET/CT 16
CTI PET SYSTEMS, INC. 510(k) NO: K023768(SPECIAL)
ATTN: WILLIAM SKREMSKY PHONE NO : 865-218-2522
810 INNOVATION DR. SE DECISION MADE: 25-NOV-02
KNOXVILLE, TN 37932-2571 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYNOSURE PHOTOGENICA SV
CYNOSURE, INC. 510(k) NO: K021444(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
10 ELIZABETH DR. SE DECISION MADE: 20-NOV-02
CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C
DADE BEHRING, INC. 510(k) NO: K022977(TRADITIONAL)
ATTN: RICHARD M VAUGHT PHONE NO : 302-631-6567
GLASGOW BUSINESS COMMUNITY SE DECISION MADE: 27-NOV-02
BLDG 500, MS 514 P.O.BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: CONTROL PLASMA N
DADE BEHRING, INC. 510(k) NO: K023309(TRADITIONAL)
ATTN: DONNA A WOLF PHONE NO : 302-631-0384
514 GBC DRIVE SE DECISION MADE: 01-NOV-02
NEWARK, DE 19702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTROL PLASMA P
DADE BEHRING, INC. 510(k) NO: K023312(TRADITIONAL)
ATTN: DONNA A WOLF PHONE NO : 302-631-0384
514 GBC DRIVE SE DECISION MADE: 01-NOV-02
NEWARK, DE 19702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L
DATEX-OHMEDA 510(k) NO: K022740(TRADITIONAL)
ATTN: JOEL C KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 14-NOV-02
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA S/5 WEB VIEWER WITH L-6WV02 SOFTWARE
DATEX-OHMEDA 510(k) NO: K023497(SPECIAL)
ATTN: JOEL C KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 04-NOV-02
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA HMEF MINI
DATEX-OHMEDA 510(k) NO: K023641(SPECIAL)
ATTN: JOEL C KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 27-NOV-02
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEMETECH SILK NONABSORBABLE SUTURE
DEMETECH CORP. 510(k) NO: K023029(TRADITIONAL)
ATTN: LUIS ARGUELLO PHONE NO : 305-251-2700
12119 SW 131 AVE. SE DECISION MADE: 25-NOV-02
MIAMI, FL 33186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERI-MATE STERILIZABLE HANDPIECE
DENTSPLY INTERNATIONAL 510(k) NO: K023697(SPECIAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
P.O. BOX 872 SE DECISION MADE: 06-NOV-02
570 WEST COLLEGE AVE. 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17405
DEVICE: MODIFICATION TO MONARCH SPINE SYSTEM
DEPUY ACROMED 510(k) NO: K023438(SPECIAL)
ATTN: LISA GILMAN PHONE NO : 508-880-8287
325 PARAMOUNT DR. SE DECISION MADE: 13-NOV-02
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K023453(SPECIAL)
ATTN: CHERYL HASTINGS PHONE NO : 574-372-7006
700 ORTHOPAEDIC DR. SE DECISION MADE: 13-NOV-02
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION;
DIDECO S.P.A. 510(k) NO: K021732(TRADITIONAL)
ATTN: BARRY SALL PHONE NO : 781-434-4742
195 WEST STREET SE DECISION MADE: 04-NOV-02
WALTHAM, MA 02451-1163 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005
DIGIRAD CORP. 510(k) NO: K023110(TRADITIONAL)
ATTN: COREY STEWART PHONE NO : 858-578-5300
9350 TRADE PLACE SE DECISION MADE: 22-NOV-02
SAN DIEGO, CA 92126-6334 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIXION INTERLOCKING PROXIMAL FEMUR INTRAMEDULLARY NAILING SYSTEM
DISCO-O-TECH MEDICAL TECHNOLOGIES,510(k) NO: K023437(SPECIAL)
ATTN: YAEL RUBIN PHONE NO : 972 995 11511
3 HASADNOAT ST. SE DECISION MADE: 14-NOV-02
HERZLIA, ISRAEL 46728 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN
DOLPHIN MEDICAL INC. 510(k) NO: K014218(TRADITIONAL)
ATTN: JON WERNER PHONE NO : 813-818-7488
13801 MCCORMICK DRIVE SE DECISION MADE: 07-NOV-02
TAMPA, FL 33626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM
DOREX, INC. 510(k) NO: K023434(SPECIAL)
ATTN: MEL KUTAS PHONE NO : 714-639-0700
954 NORTH LEMON ST. SE DECISION MADE: 14-NOV-02
ORANGE, CA 92867 510(k) STATEMENT
DEVICE: EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-400M
EIKON HEALTHCARE DEVICE CORP. 510(k) NO: K021239(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO 58, FU-CHIUN ST. SE DECISION MADE: 08-NOV-02
HSIN-CHU CITY,, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-200M/HD
EIKON HEALTHCARE DEVICE CORP. 510(k) NO: K021240(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO 58, FU-CHIUN ST. SE DECISION MADE: 08-NOV-02
HSIN-CHU CITY,, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: EQUILASE SYSTEM
EQUILASERS, INC 510(k) NO: K022464(TRADITIONAL)
ATTN: RICHARD C SAM PHONE NO : 408-588-1212
3350 SCOTT BOULEVARD SE DECISION MADE: 21-NOV-02
UNIT 5 510(k) SUMMARY AVAILABLE FROM FDA
SANTA CLARA, CA 95054
DEVICE: NESSY (OMEGA) DISPOSABLE SPLIT RETURN ELECTRODES, MODELS P/N: 20
ERBE USA, INC. 510(k) NO: K023812(SPECIAL)
ATTN: JOHN TARTAL PHONE NO : 770-955-4400
2225 NORTHWEST PARKWAY SE DECISION MADE: 29-NOV-02
MARIETTA, GA 30067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORIA SPINAL CLIP SYSTEM
EUROSURGICAL S.A. 510(k) NO: K021679(TRADITIONAL)
ATTN: DAVID SCHLERF PHONE NO : 925-356-2640
200 GREGORY LANE SUITE C-100 SE DECISION MADE: 19-NOV-02
PLEASANT HILL, CA 94529 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSPIRATION VENTILATOR SYSTEM
EVENT MEDICAL LTD 510(k) NO: K021112(TRADITIONAL)
ATTN: MIKE GRIFFITHS PHONE NO : 760-497-3553
800 GRAND AVENUE SE DECISION MADE: 22-NOV-02
SUITE C3 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92008
DEVICE: EVER-MORE POWDER-FREE LATEX EXAMINATION GLOVES, BLUE COLOR
EVER-MORE LATEX PRODUCTS SDN BHD 510(k) NO: K023522(TRADITIONAL)
ATTN: CHIA MENG CHANG PHONE NO : 606 553 1581
LOT 555, 6 3/4 MILE SE DECISION MADE: 29-NOV-02
JALAN GANGSA, DURIAN TUNGGALL 510(k) STATEMENT
MELAKA, MALAYSIA 76100
DEVICE: EVER-MORE POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES
EVER-MORE LATEX PRODUCTS SDN BHD 510(k) NO: K023523(TRADITIONAL)
ATTN: CHIA MENG CHENG PHONE NO : 606 553 1581
LOT 555, 6 3/4 MILE SE DECISION MADE: 29-NOV-02
JALAN GANGSA, DURIAN TUNGGALL 510(k) STATEMENT
MELAKA, MALAYSIA 76100
DEVICE: EVER-MORE POWDER-FREE LATEX EXAMINATION GLOVES
EVER-MORE LATEX PRODUCTS SDN BHD 510(k) NO: K023524(TRADITIONAL)
ATTN: CHIA MENG CHENG PHONE NO : 606 553 1581
LOT 555, 6 3/4 MILE SE DECISION MADE: 29-NOV-02
JALAN GANGSA, DURIAN TUNGGALL 510(k) STATEMENT
MELAKA, MALAYSIA 76100
DEVICE: EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL
EXACTECH, INC. 510(k) NO: K023646(SPECIAL)
ATTN: LISA SIMPSON PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 13-NOV-02
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: "FEMTEX" TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMP
FIRST QUALITY HYGIENIC, INC. 510(k) NO: K023479(TRADITIONAL)
ATTN: ROBERT J STAAB PHONE NO : 201-327-0035
73 FRANKLIN TURNPIKE SE DECISION MADE: 26-NOV-02
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOTONA TANDEM LASER SYSTEM
FOTONA D.D. 510(k) NO: K022837(TRADITIONAL)
ATTN: MOJCA VALJAVEC PHONE NO : 386 1 5009114
STEGNE 7, SE DECISION MADE: 25-NOV-02
LJUBLJANA, SLOVENIA 1210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOTONA DUALIS ER:YAG/KTP LASER SYSTEM
FOTONA D.D. 510(k) NO: K022838(TRADITIONAL)
ATTN: MOJCA VALJAVEC PHONE NO : 386 1 5009114
STEGNE 7, SE DECISION MADE: 25-NOV-02
LJUBLJANA, SLOVENIA 1210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOTONA DUALIS PLUS ND:YAG LASER SYSTEM
FOTONA D.D. 510(k) NO: K022839(TRADITIONAL)
ATTN: MOJCA VALJAVEC PHONE NO : 386 1 5009114
STEGNE 7, SE DECISION MADE: 25-NOV-02
LJUBLJANA, SLOVENIA 1210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRESENIUS ICARE MONITORING SYSTEM
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K021060(TRADITIONAL)
ATTN: NICHOLE RIEK PHONE NO : 781-402-9785
95 HAYDEN AVE. SE DECISION MADE: 13-NOV-02
LEXINGTON, MA 02420-9192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CLASSIC GREAT TOE IMPLANT
FUTURA BIOMEDICAL 510(k) NO: K023562(SPECIAL)
ATTN: LOUISE M FOCHT PHONE NO : 760-599-1670
990 PARK CENTER DR., SUITE H SE DECISION MADE: 13-NOV-02
VISTA, CA 92083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXTRA LARGE BODY COIL
GE MEDICAL SYSTEMS 510(k) NO: K023442(SPECIAL)
ATTN: LARRY KROGER PHONE NO : 262-544-3894
P.O. BOX 414 SE DECISION MADE: 05-NOV-02
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CENTRICITY PACS PLUS
GE MEDICAL SYSTEMS 510(k) NO: K023557(TRADITIONAL)
ATTN: SCOTT EVANS PHONE NO : 847-704-8878
800 E. BUSINESS CENTER DR SE DECISION MADE: 07-NOV-02
MOUNT PROSPECT, IL 60056 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: INNOVA 4100
GE MEDICAL SYSTEMS, INC. 510(k) NO: K023178(TRADITIONAL)
ATTN: LARRY A KROGER, PH.D PHONE NO : 414-544-3894
3000 N. GRANDVIEW BLVD. SE DECISION MADE: 26-NOV-02
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEER LIGHT COMPACT DIGITAL HOLTER RECORDER
GENERAL ELECTRIC MEDICAL SYSTEMS I510(k) NO: K021470(TRADITIONAL)
ATTN: LISA LEE MICHELS PHONE NO : 262-293-1609
8200 WEST TOWER AVE. SE DECISION MADE: 14-NOV-02
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADLITE TISSUE RETRACTOR SYSTEM
GENZYME BIOSURGERY 510(k) NO: K022989(TRADITIONAL)
ATTN: KAREN K SYLVIA PHONE NO : 508-677-6448
600 AIRPORT RD. SE DECISION MADE: 25-NOV-02
FALL RIVER, MA 02720-4740 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILENTFLOW 2 EXHALATION SYSTEM, MODEL WM 23650
GOTTLIEB WEINMANN GERAETE FUER MED510(k) NO: K022934(TRADITIONAL)
ATTN: ECKHARDT ALBERS PHONE NO : 011 494 054702180
KRONSAALSWEG 40 SE DECISION MADE: 14-NOV-02
HAMBURG, GERMANY 22525 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP,
GUIDANT CARDIAC SURGERY 510(k) NO: K023629(TRADITIONAL)
ATTN: ANNE SCHALEGENHAFT PHONE NO : 408-845-1913
3200 LAKESIDE DR. SE DECISION MADE: 12-NOV-02
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ESSEX ENDOSCOPE, MODEL SXD-1000
GUIDANT CORP. 510(k) NO: K023627(TRADITIONAL)
ATTN: ANNE SCHLAGENHAFT PHONE NO : 408-845-1842
3200 LAKESIDE DRIVE SE DECISION MADE: 12-NOV-02
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: EVEREST BIPOLAR CUTTING FORCEPS AND GYRUS BIPOLAR CUTTING FORCEP
GYRUS MEDICAL, INC. 510(k) NO: K023492(SPECIAL)
ATTN: FREDERICK G MADES PHONE NO : 763-416-3000
6655 WEDGWOOD ROAD, # 105 SE DECISION MADE: 13-NOV-02
MINNEAPOLIS, MN 55311-3602 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PK ZIP WING CUTTING DISSECTOR
GYRUS MEDICAL, INC. 510(k) NO: K023493(SPECIAL)
ATTN: FREDERICK G MADES PHONE NO : 763-416-3000
6655 WEDGWOOD ROAD SE DECISION MADE: 13-NOV-02
MINNEAPOLIS, MN 55311-3602 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES
HARTALEGA SDN BHD 510(k) NO: K022671(TRADITIONAL)
ATTN: TITO ALDAPE PHONE NO : 775-746-6600
2301 ROBB DRIVE SE DECISION MADE: 18-NOV-02
RENO, NV 89523 510(k) STATEMENT
DEVICE: HEMCON BANDAGE
HEMCON, INC. 510(k) NO: K023298(TRADITIONAL)
ATTN: JAMES F HENSEL PHONE NO : 503-245-0459
10575 SW CASCADE AVE. SE DECISION MADE: 04-NOV-02
SUITE 130 510(k) SUMMARY AVAILABLE FROM FDA
TIGARD, OR 97223
DEVICE: HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DE
HOLOGIC, INC. 510(k) NO: K023398(SPECIAL)
ATTN: RICHARD L FOLLETT PHONE NO : 781-999-7300
35 CROSBY DR. SE DECISION MADE: 08-NOV-02
BEDFORD, MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCORPIO CR AND PS CO CR FEMORAL COMPONENTS WITH TITANIUM PLASMA
HOWMEDICA OSTEONICS CORP. 510(k) NO: K020703(TRADITIONAL)
ATTN: MARGARET F CROWN PHONE NO : 201-831-5580
59 ROUTE 17 SE DECISION MADE: 13-NOV-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIDENT SCREW HOLE PLUG AND TRIDENT BONE SPIKE
HOWMEDICA OSTEONICS CORP. 510(k) NO: K022799(TRADITIONAL)
ATTN: MARGARET F CROWE PHONE NO : 201-831-5580
59 ROUTE 17 SE DECISION MADE: 21-NOV-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM
HYPERION, INC. 510(k) NO: K022800(TRADITIONAL)
ATTN: RADHA GOOLABSINGH PHONE NO : 305-238-3020
14100 S.W. 136TH ST. SE DECISION MADE: 25-NOV-02
MIAMI, FL 33186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CA
ICN BIOMEDICALS, INC. 510(k) NO: K023252(TRADITIONAL)
ATTN: CHARLES C.F. YU PHONE NO : 650-558-0395
1429 ROLLINS ROAD SE DECISION MADE: 22-NOV-02
BURLINGAME, CA 94010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:
ICN PHARMACEUTICALS, INC. 510(k) NO: K022817(TRADITIONAL)
ATTN: EDWARD F SMITH PHONE NO : 714-545-0100
ICN PLAZA SE DECISION MADE: 22-NOV-02
3300 HYLAND AVENUE 510(k) SUMMARY AVAILABLE FROM FDA
COSTA MESA, CA 92626
DEVICE: ARAGON WIRING SYSTEM WIRE CARTRIDGE, MODELS I0007 WIRE CARTRIDGE
IDEATRICS, INC. 510(k) NO: K022821(TRADITIONAL)
ATTN: JAMES W HELLER PHONE NO : 303-527-0515
7341 SOUTH MEADOW CT. SE DECISION MADE: 15-NOV-02
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POEDER FREE
INDUSTRIAL CLOTHINGS, LTD. 510(k) NO: K023159(TRADITIONAL)
ATTN: UMAIR AHMED PHONE NO : 94 1 437575
481A, PRINCE OF WALES AVE. SE DECISION MADE: 12-NOV-02
COLOMBO 14, SRI LANKA 510(k) STATEMENT
DEVICE: IDI-STREP B ASSAY
INFECTIO DIAGNOSTIC, INC. 510(k) NO: K022504(TRADITIONAL)
ATTN: JUDI SMITH PHONE NO : 410-592-2060
P.O. BOX 103 SE DECISION MADE: 18-NOV-02
BALDWIN, MD 21013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSOUND XT SERIES HEARING AID
INSOUND MEDICAL INC. 510(k) NO: K021867(TRADITIONAL)
ATTN: SUSAN WHICHARD PHONE NO : 510-792-4000
37500 CENTRAL COURT SE DECISION MADE: 19-NOV-02
NEWARK, CA 94560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICKLAB RSV
INTEGRATED BIOTECHNOLOGY CORP. 510(k) NO: K021789(TRADITIONAL)
ATTN: SALLY A BOOTH PHONE NO : 317-848-3263
366 RIDGEPOINT DR. SE DECISION MADE: 20-NOV-02
CARMEL, IN 46032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PISTON SYRINGE & HYPODERMIC NEEDLE
INTERNATIONAL MEDSURG CONNECTION 510(k) NO: K022159(TRADITIONAL)
ATTN: MICHELE H VOVOLKA PHONE NO : 847-856-0355
P.O. BOX 848 SE DECISION MADE: 07-NOV-02
GRAYSLAKE, IL 60030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLOSTAR NEEDLELESS CONNECTOR, MODEL FS3000
INTRAVASCULAR INCORPORATED 510(k) NO: K023585(SPECIAL)
ATTN: STEVE APERAVICH PHONE NO : 847-596-7700
3600 BUR WOOD DRIVE SE DECISION MADE: 21-NOV-02
WAUKEGAN, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM & ENDOSC
INTUITIVE SURGICAL, INC. 510(k) NO: K022574(TRADITIONAL)
ATTN: USHA S KREADEN PHONE NO : 408-523-2140
950 KIFER ROAD SE DECISION MADE: 12-NOV-02
SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STORM TDX POWER WHEELCHAIR
INVACARE CORP. 510(k) NO: K023589(TRADITIONAL)
ATTN: RAE ANN FARROW PHONE NO : 440-329-6356
ONE INVACARE WAY SE DECISION MADE: 19-NOV-02
P.O. BOX 4028 510(k) SUMMARY AVAILABLE FROM FDA
ELYRIA, OH 44036-2125
DEVICE: HYALURONIDASE SOLUTION
IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K022931(TRADITIONAL)
ATTN: WENDELL LEE PHONE NO : 800-437-5706
2511 DAIMLER ST. SE DECISION MADE: 04-NOV-02
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)
IVY BIOMEDICAL SYSTEMS, INC. 510(k) NO: K023616(SPECIAL)
ATTN: DICK LISTRO PHONE NO : 203-481-4183
11 BUSINESS PARK DR. SE DECISION MADE: 04-NOV-02
BRANFORD, CT 06405 510(k) STATEMENT
DEVICE: BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES
JOHN O. BUTLER CO. 510(k) NO: K022900(TRADITIONAL)
ATTN: KEVIN G YOST PHONE NO : 773-481-6898
4635 W. FOSTER AVE. SE DECISION MADE: 14-NOV-02
CHICAGO, IL 60630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLOOD PRESSURE MONITOR SMARTLOGIC, MODELS KP-6210 AND KP-6211
K-JUMP HEALTH CO., LTD. 510(k) NO: K022916(SPECIAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 21-NOV-02
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOCON II 400 ELECTROSURGICAL GENERATOR
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K021467(TRADITIONAL)
ATTN: JAMES A LEE PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 04-NOV-02
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOTACK
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K022853(TRADITIONAL)
ATTN: JAMES A LEE PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 25-NOV-02
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KG MEDIX DISPOSABLE SYRING, 1,3,5,10, 20, 30, 50 ML'S,KG MEDIX
KYUNG GI MEDICAL IND. CO., LTD 510(k) NO: K022057(TRADITIONAL)
ATTN: BYUNG DOO JEE PHONE NO : 823 198 72365
529-4 YULSAENG-RI DAEGOT-MYUN SE DECISION MADE: 22-NOV-02
KIMPO-SI, KYUNGGI-DO, REPUBLIC OF 510(k) STATEMENT
DEVICE: LAP SURGICAL SYSTEMS MULTIPLE INSTRUMENT GUIDE
LAP SURGICAL SYSTEMS, LLC 510(k) NO: K022686(TRADITIONAL)
ATTN: DONALD WENNER PHONE NO : 505-622-6713
100 NORTH PENNSYLVANIA SE DECISION MADE: 25-NOV-02
ROSWELL, NM 88203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLARITY
LARSON PRODUCTS, INC. 510(k) NO: K022708(TRADITIONAL)
ATTN: PETER M LARSON PHONE NO : 614-235-9100
2844 BANWICK RD SE DECISION MADE: 12-NOV-02
COLUMBUS, OH 43232-2115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKINTACT ECG ELECTRODE
LEONHARD LANG GMBH 510(k) NO: K023503(SPECIAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035
P.O. BOX 560 SE DECISION MADE: 14-NOV-02
STILLWATER, MN 55082-0560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR
LINVATEC CORP. 510(k) NO: K022827(TRADITIONAL)
ATTN: LAURA D SENEFF PHONE NO : 727-399-5234
11311 CONCEPT BLVD. SE DECISION MADE: 22-NOV-02
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUTHER SAFETY HUBER NEEDLE SET
LUTHER RESEARCH PARTNERS 510(k) NO: K021565(TRADITIONAL)
ATTN: GREY HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 14-NOV-02
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VALIDATE CHEM 9 CALIBRATION VERIFICATION TEST SET, MODEL 109
MAINE STANDARDS CO. 510(k) NO: K023352(TRADITIONAL)
ATTN: CHRISTINE BEACH PHONE NO : 207-892-1300
765 ROOSEVELT TRAIL SE DECISION MADE: 22-NOV-02
SUITE 9A 510(k) SUMMARY AVAILABLE FROM FDA
WINDHAM, ME 04062-5365
DEVICE: JIA CHEN ACUPUNCTURE NEEDLE, FOR SINGLE USE
MANDALA HEALTH CARE, LLC 510(k) NO: K023054(TRADITIONAL)
ATTN: DASHIMA DOVCHIN PHONE NO : 972-977-4180
13740 MIDWAY RD, SUITE 801 SE DECISION MADE: 13-NOV-02
DALLAS, TX 75244-4352 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHYSICAL MONITORING REGISTRATION UNIT
MARYROSE CUSIMANO, PH.D./PHIL REAS510(k) NO: K022719(TRADITIONAL)
ATTN: MARYROSE CUSIMANO PHONE NO : 954-684-9643
5367 NW 90TH AVE. SE DECISION MADE: 13-NOV-02
SUNRISE, FL 33319 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES
MAXXIM MEDICAL 510(k) NO: K023236(TRADITIONAL)
ATTN: ROY E MOSER PHONE NO : 727-556-6141
308 CHURCH ST. SE DECISION MADE: 12-NOV-02
HONEA PATH, SC 29654 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MY BREAST FRIEND, BREAST SELF-EXAM PAD
MBF SALES, LLC 510(k) NO: K023390(TRADITIONAL)
ATTN: EDUARDO MARCH PHONE NO : 301-838-3120
7361 CALHOUN PLACE SE DECISION MADE: 26-NOV-02
SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20855-2765
DEVICE: PNEUMOPERITONEUM INSUFFLATION NEEDLE
MECTRA LABS, INC. 510(k) NO: K021247(TRADITIONAL)
ATTN: CHARLES E ALLGOOD PHONE NO : 812-384-3521
P.O. BOX 350 SE DECISION MADE: 08-NOV-02
BLOOMFIELD, IN 47424 510(k) STATEMENT
DEVICE: MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB
MED-LOGICS, INC. 510(k) NO: K022982(TRADITIONAL)
ATTN: MARK MOYER PHONE NO : 949-582-3891
26061 MERIT CIRCLE, SUITE #102 SE DECISION MADE: 15-NOV-02
LAGUNA HILLS, CA 92653 510(k) STATEMENT
DEVICE: VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L
MEDICAL ACTION INDUSTRIES, INC. 510(k) NO: K022948(TRADITIONAL)
ATTN: SHARON SUESS GRAHAM PHONE NO : 828-687-3727
2 SUMMIT DRIVE SE DECISION MADE: 04-NOV-02
ARDEN, NC 28704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIZAIR COMPRESSION SYSTEM
MEDICAL COMPRESSION SYSTEMS (D.B.N510(k) NO: K023573(SPECIAL)
ATTN: ARAVA HACOHEN PHONE NO : 972 977 18130
117 AHUZAH ST. SE DECISION MADE: 21-NOV-02
RA'ANANNA 43373, ISRAEL 43373 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HAND DRILL, MODEL 11-9901-7
MEDICAL DESIGN LLC. 510(k) NO: K022712(TRADITIONAL)
ATTN: PAUL JOHN AXT PHONE NO : 605-376-6008
213 SUNSET DRIVE SE DECISION MADE: 12-NOV-02
BRANDON, SD 57005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS
MEDICAL DEVICE SERVICES 510(k) NO: K022751(TRADITIONAL)
ATTN: MARK ALDANA PHONE NO : 806-745-7718
1001 SLATON HWY SE DECISION MADE: 04-NOV-02
LUBBOCK, TX 79404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSES USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS
MEDICAL DEVICE SERVICES 510(k) NO: K022753(TRADITIONAL)
ATTN: MARK ALDANA PHONE NO : 806-745-7718
1001 SLATON HWY SE DECISION MADE: 14-NOV-02
LUBBOCK, TX 79404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDLINE ASEP PLUS SURGICAL DRAPES
MEDLINE INDUSTRIES, INC. 510(k) NO: K023432(SPECIAL)
ATTN: ANDREA HAFERKAMP PHONE NO : 800-340-6840
ONE MEDLINE PL. SE DECISION MADE: 04-NOV-02
MUNDELEIN, IL 60060-4486 510(k) STATEMENT
DEVICE: TIMEX ACCUCURVE TALKING 30 SECOND THERMOMTER
MEDPORT, INC. 510(k) NO: K023538(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808
163 CABOT STREET SE DECISION MADE: 01-NOV-02
BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL
MEDRAD, INC. 510(k) NO: K023596(SPECIAL)
ATTN: JIM FERGUSON PHONE NO : 412-767-2400
ONE MEDRAD DR. SE DECISION MADE: 08-NOV-02
INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), O
MEDTRONIC FUNCTIONAL DIAGNOSTICS A510(k) NO: K011471(TRADITIONAL)
ATTN: TOVE KJAER PHONE NO : 454 457 9000
16-18 TONSBAKKEN SE DECISION MADE: 08-NOV-02
SKOVLUNDE, DENMARK DK-2740 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 904
MEDTRONIC FUNCTIONAL DIAGNOSTICS A510(k) NO: K014269(TRADITIONAL)
ATTN: TOVE KJAER PHONE NO : 454 457 9000
16-18 TONSBAKKEN SE DECISION MADE: 21-NOV-02
SKOVLUNDE, DENMARK DK-2740 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYS
MEDTRONIC PERCUSURGE, INC. 510(k) NO: K013913(TRADITIONAL)
ATTN: MATTHEW J MOON PHONE NO : 408-530-2370
530 MERCURY DRIVE SE DECISION MADE: 15-NOV-02
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VERTE-STACK SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K023570(SPECIAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 19-NOV-02
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K023555(SPECIAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 22-NOV-02
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HIP MODULE FOR THE STEALTHSTATION SYSTEM
MEDTRONIC SURGICAL NAVIGATION TECH510(k) NO: K021980(TRADITIONAL)
ATTN: VICTORIA G RENDON PHONE NO : 720-890-3200
826 COAL CREEK CIR. SE DECISION MADE: 19-NOV-02
LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 8F LAUNCHER GUIDE CATHETER
MEDTRONIC, INC. 510(k) NO: K023402(SPECIAL)
ATTN: FRED L BOUCHER PHONE NO : 978-777-0042
37A CHERRY HILL DRIVE SE DECISION MADE: 06-NOV-02
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370
MERCURY MEDICAL 510(k) NO: K021576(TRADITIONAL)
ATTN: RONALD RUPENSKI PHONE NO : 727-573-0088
11300 49TH ST. NORTH SE DECISION MADE: 04-NOV-02
CLEARWATER, FL 33762-4800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMT POLYAXIAL PEDICLE SCREW
MICRON PRECISION ENGINEERING, INC.510(k) NO: K022768(TRADITIONAL)
ATTN: FRANK E BAILEY PHONE NO : 310-831-1873
939 EVENING SHADE DRIVE SE DECISION MADE: 13-NOV-02
SAN PEDRO, CA 90731 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHILLBUSTER
MICROTEK MEDICAL, INC. 510(k) NO: K022903(TRADITIONAL)
ATTN: THOMAS BONNER PHONE NO : 662-327-1863
512 LEHMBERG RD SE DECISION MADE: 27-NOV-02
COLUMBUS, MS 39702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRX VERTICAL POSITIONER
MOTION CONCEPTS 510(k) NO: K023426(TRADITIONAL)
ATTN: DAVID CIOLFE PHONE NO : 905 695 0134
84 CITATION DRIVE SE DECISION MADE: 21-NOV-02
CONCORD, ONTARIO, CANADA L4K 3C1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REGENECARE WOUND GEL
MPM MEDICAL, INC. 510(k) NO: K020540(TRADITIONAL)
ATTN: PAUL R MILLER PHONE NO : 972-893-4060
2301 CROWN COURT SE DECISION MADE: 01-NOV-02
IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO NEOTHERMIA'S EN-BLOC BIOPSY SYSTEM
NEOTHERMIA CORP. 510(k) NO: K023413(SPECIAL)
ATTN: SHERRIE COVAL-GOLDSMITH PHONE NO : 508-655-7820
ONE APPLE HILL SUITE 316 SE DECISION MADE: 08-NOV-02
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPERM CRYOPROTEC
NIDACON INTERNATIONAL AB 510(k) NO: K023206(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 08-NOV-02
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)
NIDEK, INC. 510(k) NO: K013694(TRADITIONAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900
21911 ERIE LANE SE DECISION MADE: 19-NOV-02
LAKE FOREST, CA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STAT PROFILE CRITICAL CARE XPRESS ANALYZER
NOVA BIOMEDICAL CORP. 510(k) NO: K022746(TRADITIONAL)
ATTN: PAUL W MACDONALD PHONE NO : 781-894-0800
200 PROSPECT ST. SE DECISION MADE: 22-NOV-02
WALTHAM, MA 02454-9141 510(k) STATEMENT
DEVICE: ORS-3000LD
O.R. SOLUTIONS, INC. 510(k) NO: K023282(TRADITIONAL)
ATTN: STEVE HANNES PHONE NO : 800-343-6771
3901 CENTERVIEW DR. SE DECISION MADE: 13-NOV-02
SUITE W 510(k) SUMMARY AVAILABLE FROM FDA
CHANTILLY, VA 20151-1689
DEVICE: 1075LD HUSH-SLUSH
O.R. SOLUTIONS, INC. 510(k) NO: K023283(TRADITIONAL)
ATTN: STEVE HANNES PHONE NO : 800-343-6771
3901 CENTERVIEW DR. SE DECISION MADE: 13-NOV-02
SUITE W 510(k) STATEMENT
CHANTILLY, VA 20151-1689
DEVICE: MANUAL TOUCHE SYSTEM
ONUX MEDICAL, INC. 510(k) NO: K022777(TRADITIONAL)
ATTN: RUTHANN DEPIETRO PHONE NO : 603-929-6200
5 MERRILL DR. SE DECISION MADE: 19-NOV-02
HAMPTON, NH 03842 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHLEBOTEST 2000
OSBORN MEDICAL CORP. 510(k) NO: K022047(TRADITIONAL)
ATTN: BILL DAVIS PHONE NO : 507-932-5028
100 WEST MAIN SE DECISION MADE: 04-NOV-02
UTICA, MN 55979 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OTI UNICONDULAR INTERPOSITIONAL SPACER
OSTEOIMPLANT TECHNOLOGY, INC. 510(k) NO: K022779(TRADITIONAL)
ATTN: SAM SON PHONE NO : 410-785-0700
11201 PEPPER RD. SE DECISION MADE: 20-NOV-02
HUNT VALLEY, MD 21031-1201 510(k) STATEMENT
DEVICE: METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
OSTEOMED CORP. 510(k) NO: K022886(TRADITIONAL)
ATTN: DAWN T HOLDEMAN PHONE NO : 972-241-3401
3750 REALTY RD. SE DECISION MADE: 25-NOV-02
ADDISON, TX 75001-4311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
OSTEOMED CORP. 510(k) NO: K022887(TRADITIONAL)
ATTN: DAWN T HOLDEMAN PHONE NO : 972-241-3401
3750 REALTY RD. SE DECISION MADE: 26-NOV-02
ADDISON, TX 75001-4311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896
PHARMACIA DIAGNOSTICS GMBH & CO. K510(k) NO: K023433(TRADITIONAL)
ATTN: MICHAEL LINSS PHONE NO : 49 761 47805310
MUNZINGERSTRASSE 7 SE DECISION MADE: 13-NOV-02
FREIBURG, GERMANY D-79111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS M5066A AND M5068A
PHILIPS MEDICAL SYSTEMS 510(k) NO: K020715(ABBREVIATED)
ATTN: TAMARA YOUNT PHONE NO : 206-664-5141
2301 FIFTH AVE., SUITE 200 SE DECISION MADE: 08-NOV-02
SEATTLE, WA 98121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS DRUG CALCULATOR SOFTWARE
PHILIPS MEDICAL SYSTEMS 510(k) NO: K023674(SPECIAL)
ATTN: DAVID OSBORN PHONE NO : 978-659-3179
3000 MINUTEMAN RD. SE DECISION MADE: 29-NOV-02
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.O
PHILIPS MEDICAL SYSTEMS 510(k) NO: K023698(SPECIAL)
ATTN: DAVID OSBORN PHONE NO : 978-659-3178
3000 MINUTEMAN RD. SE DECISION MADE: 19-NOV-02
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3812B TELESTATION
PHILIPS MEDICAL SYSTEMS 510(k) NO: K023749(SPECIAL)
ATTN: J.P. OUELLETTE PHONE NO : 978-659-4308
3000 MINUTEMAN RD. SE DECISION MADE: 19-NOV-02
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K022899(TRADITIONAL)
ATTN: LYNN HARMER PHONE NO : 425-487-7312
22100 BOTHELL EVERETT HWY. SE DECISION MADE: 22-NOV-02
P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98041-3003
DEVICE: PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS
PHOENIX DIAGNOSTICS, INC. 510(k) NO: K023268(TRADITIONAL)
ATTN: RAM NUNNA PHONE NO : 508-655-8310
8 TECH CIRCLE SE DECISION MADE: 15-NOV-02
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHFW-10
PIHSIANG MACHINERY MFG. CO. LTD. 510(k) NO: K022539(TRADITIONAL)
ATTN: CHRIS TINSLEY PHONE NO : 316-325-2629
1101 ILLINOIS SE DECISION MADE: 19-NOV-02
P.O. BOX 187 510(k) STATEMENT
NEODESHA, KS 66757
DEVICE: PLAYTEX BREAST PUMP
PLAYTEX PRODUCTS, INC. 510(k) NO: K022594(TRADITIONAL)
ATTN: PAUL A SIRACUSA PHONE NO : 201-785-8101
75 COMMERCE DR. SE DECISION MADE: 01-NOV-02
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VKS KNEE SYSTEM
PLUS ORTHOPEDICS 510(k) NO: K023416(SPECIAL)
ATTN: LOUISE FOCHT PHONE NO : 858-550-3800
6055 LUSK BLVD. SE DECISION MADE: 08-NOV-02
SAN DIEGO, CA 92121-2700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PTS PANELS LIPID PANEL TEST STRIPS
POLYMER TECHNOLOGY SYSTEMS, INC. 510(k) NO: K023558(SPECIAL)
ATTN: MARGO ENRIGHT PHONE NO : 317-870-5610
7736 ZIONSVILLE RD. SE DECISION MADE: 15-NOV-02
INDIANAPOLIS, IN 46268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL
PRIME DENTAL MANUFACTURING, INC. 510(k) NO: K022675(TRADITIONAL)
ATTN: ROLANDO MARASIGAN PHONE NO : 773-539-5927
3735 WEST BELMONT AVE. SE DECISION MADE: 07-NOV-02
CHICAGO, IL 60618 510(k) STATEMENT
DEVICE: PRIMAGARD SURGICAL EQUIPMENT DRAPES
PRIMELINE MEDICAL PRODUCTS, INC. 510(k) NO: K022868(TRADITIONAL)
ATTN: BRENDA LEE PHONE NO : 780 497 7600
10707-100TH AVE., SUITE 300 SE DECISION MADE: 08-NOV-02
EDMONTON, ALBERTA, CANADA T5J 3M1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIMAGARD SURGICAL GOWNS
PRIMELINE MEDICAL PRODUCTS, INC. 510(k) NO: K023117(TRADITIONAL)
ATTN: BRANDA LEE PHONE NO : 780 497 7600
10707 100TH AVE., SUITE 300 SE DECISION MADE: 08-NOV-02
EDMONTON, ALBERTA, CANADA T5J 3M1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIMAGARD SURGICAL GOWNS
PRIMELINE MEDICAL PRODUCTS, INC. 510(k) NO: K023266(TRADITIONAL)
ATTN: DAVID POWER PHONE NO : 716-655-3432
1591 FOUR ROD ROAD SE DECISION MADE: 08-NOV-02
ALDEN, NY 14004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CO-AXIAL INTRODUCER NEEDLE
PROMEX, INC. 510(k) NO: K022634(TRADITIONAL)
ATTN: JOSEPH L MARK PHONE NO : 317-736-0128
3049 HUDSON ST. SE DECISION MADE: 06-NOV-02
FRANKLIN, IN 46131 510(k) STATEMENT
DEVICE: PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS
PURE WATER SOLUTIONS, INC. 510(k) NO: K011005(TRADITIONAL)
ATTN: JOHN BOWER PHONE NO : 601-923-3608
3925 WEST NORTHSIDE DR. SE DECISION MADE: 01-NOV-02
JACKSON, MS 39209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIVERSAL SYSTEM, MODEL QV-800
QUANTUM MEDICAL IMAGING, LLC. 510(k) NO: K023008(TRADITIONAL)
ATTN: MARK CAMIRAND PHONE NO : 631-567-5800
2905 VETERANS MEMORIAL HIGHWAY SE DECISION MADE: 13-NOV-02
RONKONKOMA, NY 11779 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMAGECHECKER-CT WORKSTATION
R2 TECHNOLOGY 510(k) NO: K023003(TRADITIONAL)
ATTN: KATHY O'SHAUGHNESSY PHONE NO : 408-481-5696
1195 W. FREMONT AVE. SE DECISION MADE: 20-NOV-02
SUNNYVALE, CA 94087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANDOX HAEMOGLOBIN A1C
RANDOX LABORATORIES, LTD. 510(k) NO: K021897(TRADITIONAL)
ATTN: P ARMSTRONG PHONE NO : 440 289 4422413
ARDMORE, DIAMOND ROAD SE DECISION MADE: 26-NOV-02
CRUMLIN, BT29 4QY CO. 510(k) STATEMENT
ANTRIM, N. IRELAND, IRELAND BT29 4QY
DEVICE: RANDOX C-REACTIVE PROTEIN CALIBRATOR
RANDOX LABORATORIES, LTD. 510(k) NO: K022682(TRADITIONAL)
ATTN: PAULINE ARMSTRONG PHONE NO : 44 289 4422413
55 DIAMOND RD. SE DECISION MADE: 05-NOV-02
CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT
DEVICE: MIRAGE FULL FACE MASK SERIES 2
RESMED LTD. 510(k) NO: K023244(TRADITIONAL)
ATTN: ROGER KOTTER PHONE NO : 858-746-2400
14040 DANIELSON STREET SE DECISION MADE: 27-NOV-02
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIRAGE FULL FACE MASK SERIES 2
RESMED LTD. 510(k) NO: K023284(TRADITIONAL)
ATTN: ROGER KOTTER PHONE NO : 858-746-2400
14040 DANIELSON STREET SE DECISION MADE: 27-NOV-02
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIRAGE FULL FACE MASK SERIES 2
RESMED LTD. 510(k) NO: K023306(TRADITIONAL)
ATTN: ROGER KOTTER PHONE NO : 858-746-2400
14040 DANIELSON STREET SE DECISION MADE: 27-NOV-02
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS
RESPIRONICS CALIFORNIA, INC. 510(k) NO: K023350(TRADITIONAL)
ATTN: MARY FUNK PHONE NO : 760-918-7300
2271 COSMOS CT. SE DECISION MADE: 06-NOV-02
CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS PROBNP CALCHECK
ROCHE DIAGNOSTICS CORP. 510(k) NO: K020883(TRADITIONAL)
ATTN: SHERRI L COENEN PHONE NO : 317-521-3831
9115 HAGUE RD. SE DECISION MADE: 29-NOV-02
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS PROBNP IMMUNOASSAY
ROCHE DIAGNOSTICS CORP. 510(k) NO: K022516(TRADITIONAL)
ATTN: ROBERT A GREGG PHONE NO : 317-521-2386
9115 HAGUE RD. SE DECISION MADE: 19-NOV-02
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBAS INTEGRA ONLINE DAT II COCAINE II
ROCHE DIAGNOSTICS CORP. 510(k) NO: K023296(TRADITIONAL)
ATTN: KERWIN KAUFMAN PHONE NO : 317-521-7637
9115 HAGUE RD. SE DECISION MADE: 25-NOV-02
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086
RUBICOR MEDICAL, INC. 510(k) NO: K023601(SPECIAL)
ATTN: ROBERT J CHIN PHONE NO : 650-593-5225
25 HARTFORD AVENUE SE DECISION MADE: 19-NOV-02
SAN CAROLS, CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFETOUCH
RUSIN MEDICAL DEVICES 510(k) NO: K022861(TRADITIONAL)
ATTN: JAMES D RUSIN PHONE NO : 612-242-8037
3512 RUM RIVER DRIVE SE DECISION MADE: 26-NOV-02
ANOKA, MN 55303 510(k) STATEMENT
DEVICE: LUCIUS 76
SB LUCIUS, INC. 510(k) NO: K023196(TRADITIONAL)
ATTN: DAE-KYU CHANG PHONE NO : 714-530-2814
9778 KATELLA AVE. STE. 205 SE DECISION MADE: 01-NOV-02
ANAHEIM, CA 92804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERANUM 82
SB LUCIUS, INC. 510(k) NO: K023197(TRADITIONAL)
ATTN: DAE-KYU CHANG PHONE NO : 714-530-2814
9778 KATELLA AVE. STE. 205 SE DECISION MADE: 05-NOV-02
ANAHEIM, CA 92804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERANUM 90
SB LUCIUS, INC. 510(k) NO: K023198(TRADITIONAL)
ATTN: DAE-KYU CHANG PHONE NO : 714-530-2814
9778 KATELLA AVE. STE. 205 SE DECISION MADE: 01-NOV-02
ANAHEIM, CA 92804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERANUM 50
SB LUCIUS, INC. 510(k) NO: K023199(TRADITIONAL)
ATTN: DAE-KYU CHANG PHONE NO : 714-530-2814
9778 KATELLA AVE. STE. 205 SE DECISION MADE: 04-NOV-02
ANAHEIM, CA 92804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERANUM 76
SB LUCIUS, INC. 510(k) NO: K023200(TRADITIONAL)
ATTN: DAE-KYU CHANG PHONE NO : 714-530-2814
9778 KATELLA AVE. STE. 205 SE DECISION MADE: 04-NOV-02
ANAHEIM, CA 92804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIEMENS VIRTUAL SIMULATION (VSIM)
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K022036(TRADITIONAL)
ATTN: SEAN M CURRY PHONE NO : 858-675-8200
16787 BERNARDO CENTER DRIVE SE DECISION MADE: 05-NOV-02
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92128
DEVICE: SIEMENS MULTIVIEW WORKSTATION MODIFICATIONS
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K023569(SPECIAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 04-NOV-02
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOLINE ANTARES ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K023720(TRADITIONAL)
ATTN: JUDI HOFFMAN PHONE NO : 425-557-1229
22010 S.E. 51ST ST. SE DECISION MADE: 20-NOV-02
ISSAQUAH, WA 98027-7002 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: 6 CHANNEL BODY COIL
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K023571(SPECIAL)
ATTN: JAMIE YIEH PHONE NO : 732-321-4625
186 WOOD AVENUE SOUTH SE DECISION MADE: 20-NOV-02
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMATOM EMOTION 6 CT SYSTEMS
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K023687(SPECIAL)
ATTN: PRAVEEN NADKARNI PHONE NO : 732-321-4950
186 WOOD AVENUE SOUTH SE DECISION MADE: 22-NOV-02
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALOCLAIR ORAL RINSE
SINCLAIR PHARMACEUTICALS, LTD. 510(k) NO: K023155(TRADITIONAL)
ATTN: DENISE SWIFT PHONE NO : 441 483 428611
BOROUGH RD. SE DECISION MADE: 25-NOV-02
GODALMING, SURREY, UNITED KINGDOM 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STELLAR SERIES SURGICAL LIGHTS WITH HERMES
SKYTRON, DIV. THE KMW GROUP, INC. 510(k) NO: K021585(TRADITIONAL)
ATTN: KARI OGREEN PHONE NO : 616-957-0500
5000 36TH ST., S.E. SE DECISION MADE: 13-NOV-02
GRAND RAPIDS, MI 49512 510(k) STATEMENT
DEVICE: SURETAC III, MODELS 7209900, 7209901
SMITH & NEPHEW, INC. 510(k) NO: K023417(SPECIAL)
ATTN: JASON BILOBRAM PHONE NO : 508-261-3770
160 DASCOMB RD. SE DECISION MADE: 07-NOV-02
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOBUCK CEMENT RESTRICTOR
SMITH & NEPHEW, INC. 510(k) NO: K023680(SPECIAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487
1450 E. BROOKS ROAD SE DECISION MADE: 19-NOV-02
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYST
SODEM SYSTEMS 510(k) NO: K023066(TRADITIONAL)
ATTN: CAROLE BURNIER PHONE NO : 41 22 7949696
110 CH. DU PONT DU CENTENAIRE SE DECISION MADE: 25-NOV-02
GENEVA, SWITZERLAND CH-1228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLOCKING TRAY
SOUTHEASTERN RADIATION PRODUCTS, I510(k) NO: K023636(TRADITIONAL)
ATTN: RICHARD SWEAT PHONE NO : 407-330-3300
2651 N. DESIGN COURT SE DECISION MADE: 22-NOV-02
SANFORD, FL 32773 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEM
SPINAL CONCEPTS, INC. 510(k) NO: K023644(SPECIAL)
ATTN: AUDREY SWEARINGEN PHONE NO : 512-918-2700
12012 TECHNOLOGY BLVD., #100 SE DECISION MADE: 25-NOV-02
AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CADENCE PEEK CEMEENT RESTRICTOR
SPINAL CONCEPTS, INC. 510(k) NO: K023647(SPECIAL)
ATTN: AUDREY SWEARINGEN PHONE NO : 512-918-2700
12012 TECHNOLOGY BLVD., #100 SE DECISION MADE: 27-NOV-02
AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RETRO REPAIR KIT, MODEL PRRK5
SPIRE BIOMEDICAL, INC. 510(k) NO: K022644(TRADITIONAL)
ATTN: DONALD FICKETT PHONE NO : 781-275-6001
ONE PATRIOTS PARK SE DECISION MADE: 06-NOV-02
BEDFORD, MA 01730-2396 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SRI/SURGICAL EXPRESS SP REUSABLE SURGICAL GOWN
SRI/SURGICAL EXPRESS, INC. 510(k) NO: K023635(TRADITIONAL)
ATTN: JACK A HAMILTON PHONE NO : 813-891-9550
12425 RACE TRACK ROAD SE DECISION MADE: 18-NOV-02
TAMPA, FL 33626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)
STELLARTECH RESEARCH CORP. 510(k) NO: K023765(SPECIAL)
ATTN: JAMES R SANTOS PHONE NO : 408-331-3000
1346 BORDEAUX DR. SE DECISION MADE: 29-NOV-02
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STEPHENS DISPOSABLE FORCEPS
STEPHENS INSTRUMENTS 510(k) NO: K022835(TRADITIONAL)
ATTN: ARCHANA JOHNSON PHONE NO : 859-259-4925
2500 SANDERSVILLE ROAD SE DECISION MADE: 01-NOV-02
LEXINGTON, KY 40511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STEPHENS DISPOSABLE SPECULUM
STEPHENS INSTRUMENTS 510(k) NO: K022836(TRADITIONAL)
ATTN: ARCHANA JOHNSON PHONE NO : 859-259-4925
2500 SANDERSVILLE ROAD SE DECISION MADE: 01-NOV-02
LEXINGTON, KY 40511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STEPHENS DISPOSABLE SCISSORS
STEPHENS INSTRUMENTS 510(k) NO: K022840(TRADITIONAL)
ATTN: ARCHANA JOHNSON PHONE NO : 859-259-4925
2500 SANDERSVILLE ROAD SE DECISION MADE: 01-NOV-02
LEXINGTON, KY 40511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STEPHENS DISPOSABLE HOOKS
STEPHENS INSTRUMENTS 510(k) NO: K022842(TRADITIONAL)
ATTN: ARCHALA JOHNSON PHONE NO : 859-259-4925
2500 SANDERSVILLE ROAD SE DECISION MADE: 01-NOV-02
LEXINGTON, KY 40511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GAYHEART CORNEAL EXCISION DEVICE
STEPHENS INSTRUMENTS 510(k) NO: K022843(TRADITIONAL)
ATTN: ARCHANA JOHNSON PHONE NO : 859-259-4925
2500 SANDERSVILLE ROAD SE DECISION MADE: 01-NOV-02
LEXINGTON, KY 40511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOVASCULAR GUIDE WIRE
STEREOTAXIS, INC. 510(k) NO: K021363(TRADITIONAL)
ATTN: GARY RAUVOLA PHONE NO : 314-615-6913
4041 FOREST PARK AVENUE SE DECISION MADE: 27-NOV-02
ST. LOUIS, MO 63108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUG
STOCKERT INSTRUMENTE GMBH 510(k) NO: K023622(ABBREVIATED)
ATTN: LYNNE LEONARD PHONE NO : 303-697-4615
20193 GOINS DRIVE SE DECISION MADE: 21-NOV-02
MORRISON, CO 80465 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER POWERED WHEELED STRETCHER
STRYKER CORP. 510(k) NO: K022309(TRADITIONAL)
ATTN: LYNETTE GABRIEL PHONE NO : 202-626-2996
1730 PENNSYLVANIA AVENUE N.W. SE DECISION MADE: 08-NOV-02
WASHINGTON, DC 20006-4706 510(k) STATEMENT
DEVICE: HEX-LOCK TEMPORARY ABUTMENT
SULZER DENTAL, INC. 510(k) NO: K014050(TRADITIONAL)
ATTN: SEAN HARIRI PHONE NO : 760-929-4300
1900 ASTON AVE. SE DECISION MADE: 13-NOV-02
CARLSBAD, CA 92008-7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RENAX HEMODIALYSIS BLOOD TRUBING SET; SUNDER HEMODIALYSIS BLOOD
SUNDER BIOMEDICAL TECH. CO., LTD. 510(k) NO: K014140(TRADITIONAL)
ATTN: TONY HUNG PHONE NO :
10F-1, 1-67, WU-CHUAN RD. SE DECISION MADE: 18-NOV-02
TAICHUNG CITY, CHINA (TAIWAN) 403 510(k) STATEMENT
DEVICE: SUNPEX TECHNOLOGIES MODEL SE 01
SUNPEX TECHNOLOGY CO., LTD. 510(k) NO: K021925(ABBREVIATED)
ATTN: LEONARD FRIER PHONE NO : 410-354-3300
914 WEST PATAPSCO AVENUE SE DECISION MADE: 08-NOV-02
BALTIMORE, MD 21230 510(k) STATEMENT
DEVICE: BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540
SWEMED LAB INTERNATIONAL AB 510(k) NO: K022643(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813
555 13TH STREET N.W. SE DECISION MADE: 05-NOV-02
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, PURPLE COLOR
SYNTEX HEALTHCARE PRODUCTS CO. LTD510(k) NO: K022784(TRADITIONAL)
ATTN: TAN SWU CHOON PHONE NO : 86 311 3270666
NO. 1 FANJIAZHUNG INDUSTRIAL SE DECISION MADE: 13-NOV-02
ZONE 510(k) STATEMENT
XINJI CITY, HEBEI PROVINCE, CHINA 052360
DEVICE: CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)
SYNTHES 510(k) NO: K013072(TRADITIONAL)
ATTN: THOMAS M MARGUIRE PHONE NO : 610-647-9700
1690 RUSSELL ROAD SE DECISION MADE: 26-NOV-02
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES LOW PROFILE NEURO SYSTEM
SYNTHES (USA) 510(k) NO: K022012(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 610-647-9700
P.O. BOX 1766 SE DECISION MADE: 01-NOV-02
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222
DEVICE: SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM
SYNTHES (USA) 510(k) NO: K022791(TRADITIONAL)
ATTN: VIKKI M HOFFMAN PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 13-NOV-02
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES CERVIFIX/ AXON
SYNTHES (USA) 510(k) NO: K023675(SPECIAL)
ATTN: VIKKI M HOFFMAN PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 26-NOV-02
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TMD SAFETY SYRINGE (FA14 SERIES 10ML/FA15 SERIES 20ML)
TAIJECT MEDICAL DEVICE CO., LTD. 510(k) NO: K023458(SPECIAL)
ATTN: JIM-SON CHOU PHONE NO : 949-854-3872
19502 SIERRA MIA ROAD SE DECISION MADE: 07-NOV-02
IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALPHATRAC, MODEL A 205
TEFTEC CORP. 510(k) NO: K022652(TRADITIONAL)
ATTN: THOMAS E FINCH III PHONE NO : 210-477-0330
12450 NETWORK BLVD. SE DECISION MADE: 21-NOV-02
SAN ANTONIO, TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TL100 TENSMETER BLOOD PRESSURE MONITORING SYSTEM
TENSYS MEDICAL, INC. 510(k) NO: K022783(TRADITIONAL)
ATTN: STUART L GALLANT PHONE NO : 858-552-1941
5825 OBERLIN DRIVE SE DECISION MADE: 19-NOV-02
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92121
DEVICE: CIRCUIT TUBINGS WITH X-COATING
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K023056(TRADITIONAL)
ATTN: KAZUHITO INOUE PHONE NO : 800-283-7866
125 BLUE BALL ROAD SE DECISION MADE: 26-NOV-02
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADAPTERS WITH X-COATING
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K022918(TRADITIONAL)
ATTN: KAZUHITO INOUE PHONE NO : 800-283-7866
125 BLUE BALL ROAD SE DECISION MADE: 27-NOV-02
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES
THE OLYMPUS OPTICAL CO. 510(k) NO: K023767(SPECIAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE DRIVE SE DECISION MADE: 29-NOV-02
MELVILLE, NY 11747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMAGE THERMACOOL TC SYSTEM
THERMAGE, INC. 510(k) NO: K021402(TRADITIONAL)
ATTN: PAMELA M BUCKMAN PHONE NO : 510-259-7116
4058 POINT EDEN WAY SE DECISION MADE: 05-NOV-02
HAYWARD, CA 94545-3721 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THOMAS MEDICAL ELECTRODES
THOMAS MEDICAL, INC. 510(k) NO: K022593(TRADITIONAL)
ATTN: THOMAS J ZINNANTI PHONE NO : 770-360-7778
4100-C NINE MCFARLAND DRIVE SE DECISION MADE: 01-NOV-02
ALPHARETTA, GA 30004 510(k) STATEMENT
DEVICE: SPI EASY DENTAL IMPLANT ABUTMENT
THOMMEN MEDICAL, AG 510(k) NO: K023645(SPECIAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
4329 GRAYDON ROAD SE DECISION MADE: 13-NOV-02
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TILITE YG AND TILITE YGS
TISPORT 510(k) NO: K023606(TRADITIONAL)
ATTN: RICHARD S FORMAN PHONE NO : 509-586-6117
1426 EAST THIRD AVE. SE DECISION MADE: 19-NOV-02
KENNEWICK, WA 99337-9669 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXCELART WITH PIANISSIMO XG/AG SPIN EDITION, MODEL MRT-1501/P3,
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K023511(TRADITIONAL)
ATTN: MICHAELA MAHL PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 05-NOV-02
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: CT CARDIAC FUNCTION ANALYSIS SOFTWARE, MODELS CSCF-001A AND CSCF
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K023760(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 22-NOV-02
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH
TRIMEDYNE, INC. 510(k) NO: K022655(TRADITIONAL)
ATTN: GLENN D YEIK PHONE NO : 949-559-5300
15091 BAKE PKWY. SE DECISION MADE: 07-NOV-02
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015
TUTA HEALTHCARE PTY LIMITED 510(k) NO: K023039(TRADITIONAL)
ATTN: OMID SOURESRAFIL PHONE NO : 612 942 70300
318-332 BURNS BAY ROAD SE DECISION MADE: 07-NOV-02
LANE COVE 510(k) SUMMARY AVAILABLE FROM FDA
SYDNEY NSW, AUSTRALIA 2066
DEVICE: PURTIAN BENNETT, GOOD KNIGHT 420G MODEL M-113900-US; PURTAN BENN
TYCO HEALTHCARE NANCY 510(k) NO: K020886(ABBREVIATED)
ATTN: MOUSTAFA ANKI PHONE NO : 333 834 48500
10 ALLEE PELLETIER DOISY SE DECISION MADE: 01-NOV-02
VILLERS-LES-NANCY, FRANCE 54601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
UNIPATH LTD. 510(k) NO: K023699(SPECIAL)
ATTN: LOUISE ROBERTS PHONE NO : 441 234 835564
PRIORY BUSINESS PARK SE DECISION MADE: 27-NOV-02
BEDFORD, UNITED KINGDOM MK44 3UP 510(k) STATEMENT
DEVICE: AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
UNITED STATES SURGICAL, A DIVISION510(k) NO: K020804(TRADITIONAL)
ATTN: SARAH HUBENY PHONE NO : 203-845-1352
150 GLOVER AVE SE DECISION MADE: 19-NOV-02
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES
USA INSTRUMENTS, INC. 510(k) NO: K022007(TRADITIONAL)
ATTN: CHRISTIE SHUMAKER PHONE NO : 330-562-1000
1515 DANNER DRIVE SE DECISION MADE: 04-NOV-02
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO GELBFISH VASCULAR DILATORS
VASCUMETRIX, LLC 510(k) NO: K023507(SPECIAL)
ATTN: NICK RAIBLE PHONE NO : 480-807-6300
2824 NORTH POWER RD., #113-278 SE DECISION MADE: 08-NOV-02
MESA, AZ 85215-1674 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUNDUS AUTOIMAGER
VISUAL PATHWAYS, INC. 510(k) NO: K020888(TRADITIONAL)
ATTN: GERALD (GARY) F BUCK PHONE NO : 928-778-5002
334 WHITE SPAR RD. SE DECISION MADE: 07-NOV-02
PRESCOTT, AZ 86303-4238 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT
VITAL SCIENTIFIC N.V. 510(k) NO: K022021(TRADITIONAL)
ATTN: ISRAEL M STEIN PHONE NO : 617-527-9933
ONE GATEWAY CENTER SUITE 411 SE DECISION MADE: 01-NOV-02
NEWTON, MA 02458 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECLUDE MVP DURA SUBSTITUTE
W. L. GORE & ASSOCIATES, INC. 510(k) NO: K021477(TRADITIONAL)
ATTN: TIMOTHY J RYNN PHONE NO : 928-779-2771
3450 WEST KILTIE LANE SE DECISION MADE: 08-NOV-02
FLAGSTAFF, AZ 86002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GORE 3.0T TORSO ARRAY
W.L. GORE & ASSOCIATES,INC 510(k) NO: K023679(TRADITIONAL)
ATTN: TRACY WOLF PHONE NO : 800-441-7404
750 OTT'S CHAPEL ROAD SE DECISION MADE: 18-NOV-02
NEWARK, DE 19713 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED)
WESTCON CONTACT LENS CO., INC. 510(k) NO: K023530(TRADITIONAL)
ATTN: CAROL NOBLE PHONE NO : 970-245-3845
611 EISENHAUER ST. SE DECISION MADE: 26-NOV-02
GRAND JUNCTION, CO 81505 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIENER LAB. BILIRRUBINA TOTAL AA
WIENER LABORATORIES S.A.I.C. 510(k) NO: K022962(TRADITIONAL)
ATTN: VIVIANA CETOLA PHONE NO : 54 341 4329191
2944 RIOBAMBA SE DECISION MADE: 01-NOV-02
ROSARIO, ARGENTINA 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WMT-TCP BONE GRAFT SUBSTITUTE
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K022629(ABBREVIATED)
ATTN: EHAB M ESMAIL PHONE NO : 901-867-4732
5677 AIRLINE RD. SE DECISION MADE: 05-NOV-02
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES
YTY INDUSTRY (MANJUNG) SDN. BHD. 510(k) NO: K023590(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 08-NOV-02
SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 289
TOTAL WITH SUMMARIES 249
TOTAL WITH STATEMENTS 40
Updated 12/05/2002
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