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510(k)s Final Decisions Rendered for March 2003 |
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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-MAR-2003 THROUGH 31-MAR-2003
DEVICE: FIXOBRIDGE 3-CEMENT
ADVANCED HEALTHCARE LTD. 510(k) NO: K024287(TRADITIONAL)
ATTN: DAGMAR MAESER PHONE NO : 828-622-7572
271 WALTROUP ROAD SE DECISION MADE: 21-MAR-03
P.O. BOX 457 510(k) STATEMENT
HOT SPRINGS, NC 28743
DEVICE: RAPID PROGRAMMAR
ADVANCED NEUROMODULATION SYSTEMS 510(k) NO: K030118(TRADITIONAL)
ATTN: RASHMI MOZA PHONE NO : 972-309-8000
6501 WINDCREST DRIVE SUITE 100 SE DECISION MADE: 11-MAR-03
PLANO, TX 75024 510(k) STATEMENT
DEVICE: MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD
ADVANCED NEUROMODULATION SYSTEMS 510(k) NO: K030674(SPECIAL)
ATTN: DREW JOHNSON PHONE NO : 972-309-8089
6501 WINDCREST DRIVE SUITE 100 SE DECISION MADE: 28-MAR-03
PLANO, TX 75024 510(k) STATEMENT
DEVICE: MPM-NET
AEROTEL MEDICAL SYSTEMS (1998) LTD510(k) NO: K030825(SPECIAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 SE DECISION MADE: 28-MAR-03
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER
AESCULAP, INC. 510(k) NO: K024349(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 610-797-9300
3773 CORPORATE PKWY. SE DECISION MADE: 24-MAR-03
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV
AESCULAP, INC. 510(k) NO: K030698(SPECIAL)
ATTN: MATTHEW M HULL PHONE NO : 610-797-9300
3773 CORPORATE PKWY. SE DECISION MADE: 20-MAR-03
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVA DIGITAL DENTAL X-RAY SYSTEM
AFP IMAGING CORP. 510(k) NO: K030647(SPECIAL)
ATTN: MARY MCNAMARA-CCULLINANE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 20-MAR-03
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100
AIREX INC. 510(k) NO: K023693(TRADITIONAL)
ATTN: WILLIAM HASLEBACHER PHONE NO : 425-462-9200
13704 S.E. 17TH STREET SE DECISION MADE: 12-MAR-03
BELLEVUE, WA 98005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS
ALLIANCE MEDICAL CORP. 510(k) NO: K024015(TRADITIONAL)
ATTN: MOIRA BARTON PHONE NO : 480-763-5300
10232 SOUTH 51ST ST. SE DECISION MADE: 04-MAR-03
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED COMPRESSION SLEEVES
ALLIANCE MEDICAL CORP. 510(k) NO: K024074(TRADITIONAL)
ATTN: MOIRA BARTON PHONE NO : 480-763-5300
10232 SOUTH 51ST ST. SE DECISION MADE: 07-MAR-03
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED COMPRESSION SLEEVES
ALLIANCE MEDICAL CORP. 510(k) NO: K024087(TRADITIONAL)
ATTN: MOIRA BARTON PHONE NO : 480-763-5300
10232 SOUTH 51ST ST. SE DECISION MADE: 11-MAR-03
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALTON PT STEPPER
ALTON DESIGN, LLC 510(k) NO: K024183(TRADITIONAL)
ATTN: GREG WIITA PHONE NO : 561-721-0595
2655 N. OCEAN DRIVE SE DECISION MADE: 17-MAR-03
SUITE 403 510(k) SUMMARY AVAILABLE FROM FDA
SINGER ISLAND, FL 33404
DEVICE: ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES
ALTUS MEDICAL, INC. 510(k) NO: K023954(TRADITIONAL)
ATTN: KATHY MAYNOR PHONE NO : 650-259-5586
821 COWAN RD. SE DECISION MADE: 18-MAR-03
BURLINGAME, CA 94010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPERBOND
AMERICAN DENT-ALL, INC. 510(k) NO: K030161(TRADITIONAL)
ATTN: PHILIP HACOPIANS PHONE NO : 818-662-0618
5140 SAN FERNANDO ROAD SE DECISION MADE: 17-MAR-03
GLENDALE, CA 91204 510(k) STATEMENT
DEVICE: MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C
AOMORI OLYMPUS CO., LTD. 510(k) NO: K022446(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
2 CORPORATE CENTER DRIVE SE DECISION MADE: 28-MAR-03
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E
ARISTA LATINDO INDUSTRIAL LTD. P.T510(k) NO: K023753(TRADITIONAL)
ATTN: LINGA SUMARTA PHONE NO : 623 266 20201195
JL K. H. MOH MANSYUR NO. 128 SE DECISION MADE: 25-MAR-03
JAKARTA, INDONESIA 11210 510(k) STATEMENT
DEVICE: VINYL EXAMINATION GLOVES, POWDER-FREE WITH VITAMIN E
ARISTA LATINDO INDUSTRIAL, LTD. P.510(k) NO: K023754(TRADITIONAL)
ATTN: LINGA SUMARTA PHONE NO : 650 697 5832
JL: K.H.MOH MANSYUR NO. 128 SE DECISION MADE: 25-MAR-03
JAKARTA, INDONESIA 11210 510(k) STATEMENT
DEVICE: ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475
ARTHREX, INC. 510(k) NO: K024291(TRADITIONAL)
ATTN: SALLY FOUST PHONE NO : 239-643-5553
2885 SOUTH HORSESHOE DR. SE DECISION MADE: 20-MAR-03
NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIDEO ARTHROSCOPE, MODELS AR-3050-30, AR-3050T-30, AR-3050-70, A
ARTHREX, INC. 510(k) NO: K030096(TRADITIONAL)
ATTN: SALLY FOUST PHONE NO : 239-643-5553
2885 SOUTH HORSESHOE DR. SE DECISION MADE: 18-MAR-03
NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000); ARTHROCARE PATIENT
ARTHROCARE CORP. 510(k) NO: K030551(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224
680 VAQUEROS AVE. SE DECISION MADE: 07-MAR-03
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925
ASEPTICO, INC. 510(k) NO: K030163(TRADITIONAL)
ATTN: GRANT RAMALEY PHONE NO : 425-487-3157
8333 216TH ST., S.E. SE DECISION MADE: 03-MAR-03
WOODINVILLE, WA 98072 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CAUTERY TIP CLEANER, MODEL-TC-100
ASPEN SURGICAL PRODUCTS, INC. 510(k) NO: K030339(TRADITIONAL)
ATTN: DEBBIE DALY PHONE NO : 888-364-7004
7425 CLYDE PARK, SUITE G SE DECISION MADE: 07-MAR-03
BYRON CENTER, MI 49315 510(k) STATEMENT
DEVICE: MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-359S6, MMT-3
AVAIL MEDICAL PRODUCTS, INC. 510(k) NO: K030149(TRADITIONAL)
ATTN: CARROLL COUNCILMAN PHONE NO : 949-263-5060
1900 CARNEGIE AVENUE SE DECISION MADE: 20-MAR-03
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STIMUPLEX-DIG-RC NERVE STIMULATOR
B. BRAUN MEDICAL, INC. 510(k) NO: K021033(SPECIAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-266-0500
901 MARCON BLVD. SE DECISION MADE: 21-MAR-03
ALLENTOWN, PA 18109-9341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISTA BASIC WITH FM SYSTEM
B. BRAUN MEDICAL, INC. 510(k) NO: K023189(TRADITIONAL)
ATTN: LINDA MORGAN PHONE NO : 972-245-2243
1601 WALLACE DR., SUITE 150 SE DECISION MADE: 20-MAR-03
CARROLLTON, TX 75006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE
BALLARD MEDICAL PRODUCTS 510(k) NO: K030721(SPECIAL)
ATTN: CINDY ELLIS PHONE NO : 801-572-6800
12050 LONE PEAK PKWY. SE DECISION MADE: 31-MAR-03
DRAPER, UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASCENSIA BREEZE BLOOD GLUCOSE METER
BAYER CORP. 510(k) NO: K024062(TRADITIONAL)
ATTN: GEORGE M TANCOS PHONE NO : 574-262-6928
1884 MILES AVE. SE DECISION MADE: 03-MAR-03
P.O. BOX 70 510(k) SUMMARY AVAILABLE FROM FDA
ELKHART, IN 46515-0070
DEVICE: URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
BAYER DIAGNOSTICS CORP. 510(k) NO: K022096(TRADITIONAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE SE DECISION MADE: 18-MAR-03
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYER LIGAND PLUS 1, 2, 3 CONTROLS
BAYER DIAGNOSTICS CORP. 510(k) NO: K030452(ABBREVIATED)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE SE DECISION MADE: 03-MAR-03
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD VACUTAINER PLUS PLASTIC URINE C&S; PRESERVAYIVE TUBES AND KITS
BD 510(k) NO: K024240(TRADITIONAL)
ATTN: JING ZHANG PHONE NO : 210-847-4717
1 BECTON DRIVE SE DECISION MADE: 26-MAR-03
MC 300 510(k) SUMMARY AVAILABLE FROM FDA
FRANKLIN LAKES, NJ 07417
DEVICE: CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBOD
BECKMAN COULTER, INC. 510(k) NO: K030408(SPECIAL)
ATTN: STAN SUGRUE PHONE NO : 305-380-4552
11800 SW 147TH AVENUE SE DECISION MADE: 04-MAR-03
MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NALIDIXIC ACID - 2-32 U
BECTON, DICKINSON AND COMPANY 510(k) NO: K030579(TRADITIONAL)
ATTN: KATHRYN BABKA POWERS PHONE NO : 410-316-4260
7 LOVETON CIR. SE DECISION MADE: 21-MAR-03
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHROMOPHARE X 65
BERCHTOLD HOLDING GMBH 510(k) NO: K024132(SPECIAL)
ATTN: JORG SCHNEIDER PHONE NO : 004 974 61181155
LUDWIGSTALER STR. 25 SE DECISION MADE: 21-MAR-03
TUTTLINGEN, GERMANY D-78532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BLUE) (TEXTURED A
BEST MANUFACTURING COMPANY-DISTRIB510(k) NO: K030075(TRADITIONAL)
ATTN: DAVID C YOUNG PHONE NO : 706-862-2302
579 EDISON STREET SE DECISION MADE: 05-MAR-03
MENLO, GA 30731 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SLENDERTONE FLEX BOTTOM & THIGH TONING SYSTEM, TYPE 511
BIO-MEDICAL RESEARCH, LTD. 510(k) NO: K022855(TRADITIONAL)
ATTN: ROBERT A DORMER PHONE NO : 202-737-5600
700 13TH ST. NW SE DECISION MADE: 06-MAR-03
SUITE 1200 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005
DEVICE: REPICCI LOCKED KEEL TIBIAL BEARING
BIOMET, INC. 510(k) NO: K030446(SPECIAL)
ATTN: TRACY J BICKEL PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 06-MAR-03
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS
BIOMET, INC. 510(k) NO: K030501(SPECIAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 219-267-6639
P.O. BOX 587 SE DECISION MADE: 20-MAR-03
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BABYCARE
BIONET COMPANY LTD 510(k) NO: K023082(ABBREVIATED)
ATTN: JAY MANSOUR PHONE NO : 678-908-8180
1308 MORNINGSIDE PARK DR. SE DECISION MADE: 03-MAR-03
ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT BI
BIOPSY SCIENCES, LLC 510(k) NO: K023694(TRADITIONAL)
ATTN: SHARON ROCKWELL PHONE NO : 714-695-9269
5582 CHALON ROAD SE DECISION MADE: 17-MAR-03
YORBA LINDA, CA 92886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-
BIOSENSORS INTERNATIONAL-USA 510(k) NO: K022004(TRADITIONAL)
ATTN: JORGE HAIDER PHONE NO : 949-553-8300
20250 ACACIA ST., SUITE 115 SE DECISION MADE: 12-MAR-03
NEWPORT BEACH, CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VACUFLASH BIOPSY SYSTEM
BIP USA, INC. 510(k) NO: K024089(TRADITIONAL)
ATTN: SIEGFRIED GRUCHOT PHONE NO : 716-284-1581
345 THIRD ST., SUITE 400 SE DECISION MADE: 11-MAR-03
NIAGARA FALLS, NY 14303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLACKSTONE "CLASSIC" ANTERIOR CERVICAL PLATE
BLACKSTONE MEDICAL, INC. 510(k) NO: K022965(TRADITIONAL)
ATTN: ALAN LOMBARDO PHONE NO : 973-633-9968
90 BROOKDALE DR. SE DECISION MADE: 28-MAR-03
SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM,
BOSTON SCIENTIFIC CORP. 510(k) NO: K030107(SPECIAL)
ATTN: JENNIFER JOHNSON PHONE NO : 508-650-8178
ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 21-MAR-03
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CONTOUR POLARIS URETERAL STENT
BOSTON SCIENTIFIC CORP. 510(k) NO: K030503(SPECIAL)
ATTN: DONNA M GARDNER PHONE NO : 508-650-8398
ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 17-MAR-03
NATRICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT
BOSTON SCIENTIFIC CORP. 510(k) NO: K030645(SPECIAL)
ATTN: TODD KORNMANN PHONE NO : 763-494-2467
ONE SCIMED PLACE SE DECISION MADE: 25-MAR-03
MAPLE GROVE, MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GDC STRETCH RESISTANT DETACHABLE COIL
BOSTON SCIENTIFIC, TARGET 510(k) NO: K030475(SPECIAL)
ATTN: JAMES LEATHLEY PHONE NO : 510-440-7836
47900 BAYSIDE PARKWAY SE DECISION MADE: 14-MAR-03
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ER800 SERIES ECG EVENT RECORDER
BRAEMAR CORP. 510(k) NO: K030856(SPECIAL)
ATTN: DAVID NORBERG PHONE NO : 952-890-5135
11481 RUPP DRIVE SE DECISION MADE: 28-MAR-03
BURNSVILLE, MN 55337 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
BRENNEN MEDICAL, INC. 510(k) NO: K030460(SPECIAL)
ATTN: KENNETH B HERLAND PHONE NO : 651-429-7413
1290 HAMMOND RD. SE DECISION MADE: 07-MAR-03
ST. PAUL, MN 55110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARD AQUAGUIDE URETERAL CONDUIT
C.R. BARD, INC. 510(k) NO: K030438(TRADITIONAL)
ATTN: FRAN HARRISON PHONE NO : 770-784-6257
8195 INDUSTRIAL BLVD. SE DECISION MADE: 17-MAR-03
COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: C.T.M. MOBILITY SCOOTER, MODEL HS-890
C.T.M. HOMECARE PRODUCT, INC. 510(k) NO: K030387(TRADITIONAL)
ATTN: ROBERT S MCQUATE PHONE NO : 602-788-5651
3636 E. COLUMBINE DRIVE SE DECISION MADE: 11-MAR-03
PHOENIX, AZ 85032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANDELA GENTLE YAG LASER SYSTEM
CANDELA CORP. 510(k) NO: K022923(TRADITIONAL)
ATTN: LORRAINE NELSON PHONE NO : 508-358-7637
530 BOSTON POST RD. SE DECISION MADE: 13-MAR-03
WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
CANDELA CORP. 510(k) NO: K024260(TRADITIONAL)
ATTN: WILLIAM H MCGRAIL PHONE NO : 508-358-7637
530 BOSTON POST RD. SE DECISION MADE: 21-MAR-03
WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
CANDELA CORP. 510(k) NO: K024335(TRADITIONAL)
ATTN: WILLIAM H MCGRAIL PHONE NO : 508-358-7637
530 BOSTON POST RD. SE DECISION MADE: 12-MAR-03
WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANDELA GENTLE LASE FAMILY OF LASER SYSTEM
CANDELA CORP. 510(k) NO: K024371(TRADITIONAL)
ATTN: WILLIAM H MCGRAIL PHONE NO : 508-358-7637
530 BOSTON POST RD. SE DECISION MADE: 31-MAR-03
WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OXICHECK
CARADYNE, LTD. 510(k) NO: K023565(ABBREVIATED)
ATTN: PAUL DRYDEN PHONE NO : 317-335-3780
6329 W. WATERVIEW CT. SE DECISION MADE: 28-MAR-03
MCCORDSVILLE, IN 46055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILIZATION CASES AND TRAYS
CARR METAL PRODUCTS, INC. 510(k) NO: K023658(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 317-335-3780
6329 WEST WATERVIEW COURT SE DECISION MADE: 25-MAR-03
MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER
CASE MEDICAL, INC. 510(k) NO: K030853(TRADITIONAL)
ATTN: MARCIA FRIEZE PHONE NO : 888-227-2273
65 RAILROAD AVE. SE DECISION MADE: 21-MAR-03
RIDGEFIELD, NJ 07657-0402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOGOS JUNIOR DENTAL CHAIR AND UNIT
CASTELLINI S.P.A. 510(k) NO: K023513(TRADITIONAL)
ATTN: GIULIANO LANZARINI PHONE NO : 051 700 877
VIA SALICETO 22 SE DECISION MADE: 26-MAR-03
CASTEL MAGGIORE, BOLOGNA, ITALY 40510(k) STATEMENT
DEVICE: AMERICAN CATHETER, MODEL W3
CATHETER LLC. 510(k) NO: K030538(TRADITIONAL)
ATTN: JOHN C DEVANNEY PHONE NO : 860-738-7188
106 GROPPO DRIVE SE DECISION MADE: 10-MAR-03
WINSTED, CT 06098-0917 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING
CD LEYCOM BV 510(k) NO: K030524(SPECIAL)
ATTN: T. LOPES PHONE NO : 31 79 3621602
ARGONSTRAAT 116 SE DECISION MADE: 03-MAR-03
ZOETERMEER, NETHERLANDS 2718 SP 510(k) STATEMENT
DEVICE: ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM
CENTERPULSE ORTHOPEDICS, INC. 510(k) NO: K030373(SPECIAL)
ATTN: AUDREY SWEARINGEN PHONE NO : 512-432-9255
9900 SPECTRUM DRIVE SE DECISION MADE: 06-MAR-03
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROMOTOR FINAL RINSE SPERM WASH MEDIUM
CERES FERTILITY, INC. 510(k) NO: K024290(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 03-MAR-03
IRVINE, CA 92606 510(k) STATEMENT
DEVICE: SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT
CHF SOLUTIONS, INC. 510(k) NO: K024124(TRADITIONAL)
ATTN: AMY PETERSON PHONE NO : 763-463-4620
SUITE 170-7601 NORTHLAND DRIVE SE DECISION MADE: 14-MAR-03
BROOKLYN PARK, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-4
CLASS A ENTERPRISES, INC. 510(k) NO: K023472(TRADITIONAL)
ATTN: SAMANTHA L DRAPER PHONE NO : 760-956-7851
P.O. BOX 401964-16039 SE DECISION MADE: 18-MAR-03
WALNUT ST. STE C 510(k) STATEMENT
HESPERIA, CA 92340
DEVICE: LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMP
CLINIQA CORPORATION 510(k) NO: K030566(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900
1432 SOUTH MISSION ROAD SE DECISION MADE: 13-MAR-03
FALLBROOK, CA 92028 510(k) STATEMENT
DEVICE: CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3
CLINIQA CORPORATION 510(k) NO: K030705(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900
1432 SOUTH MISSION ROAD SE DECISION MADE: 26-MAR-03
FALLBROOK, CA 92028 510(k) STATEMENT
DEVICE: CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LE
CLINIQA CORPORATION 510(k) NO: K030768(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-728-5205
1432 SOUTH MISSION ROAD SE DECISION MADE: 21-MAR-03
FALLBROOK, CA 92028 510(k) STATEMENT
DEVICE: COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700
COBE CARDIOVASCULAR, INC. 510(k) NO: K030462(SPECIAL)
ATTN: CHARLES COPPERBERG PHONE NO : 303-467-6521
14401 WEST 65TH WAY SE DECISION MADE: 06-MAR-03
ARVADA, CO 80004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEM, MODEL 004110
COLLINS MEDICAL, INC. 510(k) NO: K030464(SPECIAL)
ATTN: DONALD HENTON PHONE NO : 781-843-0610
220 WOOD RD. SE DECISION MADE: 14-MAR-03
BRAINTREE, MA 02184-2408 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED CONCENTRIC RETRIEVER, MODEL 90037
CONCENTRIC MEDICAL, INC. 510(k) NO: K030476(SPECIAL)
ATTN: KEVIN F MACDONALD PHONE NO : 650-938-2100
1380 SHOREBIRD WAY SE DECISION MADE: 11-MAR-03
MOUNTAIN VIEW, CA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENHANCE SPERM FREEZE
CONCEPTION TECHNOLOGY, INC. 510(k) NO: K030117(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 20-MAR-03
IRVINE, CA 92606 510(k) STATEMENT
DEVICE: SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM
CORDIS CORP. 510(k) NO: K030409(SPECIAL)
ATTN: SAM MIRZA PHONE NO : 786-313-2007
14201 N.W. 60TH AVE. SE DECISION MADE: 10-MAR-03
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE
CP MEDICAL 510(k) NO: K030351(ABBREVIATED)
ATTN: MARY ANN GREENAWALT PHONE NO : 503-232-1555
836 N.E. 24TH AVE. SE DECISION MADE: 28-MAR-03
PORTLAND, OR 97232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CPCA2000 COUNTERPULSATION SYSTEM
CPCA2000 INC 510(k) NO: K030532(TRADITIONAL)
ATTN: MICHAEL DAYTON PHONE NO : 813-949-6090
4608 RUE BORDEAUX SE DECISION MADE: 14-MAR-03
LUTZ, FL 33558 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMASSIST PROCEDURE MASK/SURGICAL MASKS (GREEN, BLUE, YELLOW, P
CREATIVE CONTRACT (M) SDN BHD 510(k) NO: K021533(TRADITIONAL)
ATTN: MARK REIBER PHONE NO : 918-245-8400
8220 CHARLES PAGE BLVD SE DECISION MADE: 05-MAR-03
SAND SPRINGS, OK 74063 510(k) STATEMENT
DEVICE: DERMASSIST FLUID RESISTANT SURGICAL MASK (ORANGE) AND PROCEDURE
CREATIVE CONTRACT (M) SDN BHD 510(k) NO: K021539(TRADITIONAL)
ATTN: MARK REIBER PHONE NO : 918-245-8400
8220 CHARLES PAGE BLVD SE DECISION MADE: 05-MAR-03
SAND SPRINGS, OK 74063 510(k) STATEMENT
DEVICE: DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR
CREATIVE CONTRACT (M) SDN BHD 510(k) NO: K021546(TRADITIONAL)
ATTN: MARK REIBER PHONE NO : 918-245-8400
8220 CHARLES PAGE BLVD SE DECISION MADE: 05-MAR-03
SAND SPRINGS, OK 74063 510(k) STATEMENT
DEVICE: DENTAL PROTECTOR
DENTAL CONCEPTS LLC. 510(k) NO: K024261(TRADITIONAL)
ATTN: MICHAEL LESSER PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 26-MAR-03
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REACTIVE SKIN DECONTAMINATION LOTION
DEPT. OF THE ARMY 510(k) NO: K023969(TRADITIONAL)
ATTN: RONALD E CLAWSON PHONE NO : 310-619-2016
CHEMICAL-BIOLOGICAL MGT.OFFICE SE DECISION MADE: 25-MAR-03
64 THOMAS JEFFERSON DRIVE 510(k) SUMMARY AVAILABLE FROM FDA
FORT DETRICK, MD 21702
DEVICE: DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEM
DIAGNOSTIC ULTRASOUND CORP. 510(k) NO: K030763(TRADITIONAL)
ATTN: NANCY GERTLAR PHONE NO : 425-867-1348
21222 30TH DRIVE SE, STE. 120 SE DECISION MADE: 26-MAR-03
BOTHELL, WA 98021 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BL
DIDECO S.P.A. 510(k) NO: K030154(ABBREVIATED)
ATTN: BARRY SALL PHONE NO : 781-434-4742
195 WEST STREET SE DECISION MADE: 31-MAR-03
WALTHAM, MA 02451-1163 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER
DOLPHIN MEDICAL INC. 510(k) NO: K024235(SPECIAL)
ATTN: JON WERNER PHONE NO : 813-818-7488
13801 MCCORMICK DRIVE SE DECISION MADE: 17-MAR-03
TAMPA, FL 33626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUOMED, SERIES 500, (MODELS ID 500, FL 500)
DUOMED INC. 510(k) NO: K030140(TRADITIONAL)
ATTN: CHARLES KOKINOS PHONE NO : 561-686-2619
400 NORTHPOINT PARKWAY #406 SE DECISION MADE: 18-MAR-03
WEST PALM BEACH, FL 33407 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM
EBI, L.P. 510(k) NO: K030372(TRADITIONAL)
ATTN: FREDERIC TESTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 06-MAR-03
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI DYNAFIX COMPRESSION BONE SCREW
EBI, L.P. 510(k) NO: K030706(TRADITIONAL)
ATTN: FREDERIC TESTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 20-MAR-03
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORG@NIZER, MODEL VERSION 3.0
EBIT SANITA, S.P.A. 510(k) NO: K030363(TRADITIONAL)
ATTN: COLLEEN DENSMORE PHONE NO : 317-849-1916
7992 CASTLEWAY DRIVE SE DECISION MADE: 27-MAR-03
INDIANPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 20.1" MONOCHROME LCD MONITOR, RADIFORCE G21
EIZO NANAO CORPORATION 510(k) NO: K024358(TRADITIONAL)
ATTN: AKIRA WAKAYAMA PHONE NO : 81 596 370190
153 SHIMOKASHIWANO, MATTO SE DECISION MADE: 25-MAR-03
ISHIKAWA 924-8566, JAPAN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATAC CALCIUM REAGENT AND ATAC CALIBRATOR
ELAN DIAGNOSTICS 510(k) NO: K023105(TRADITIONAL)
ATTN: WYNN STOCKING PHONE NO : 714-672-3553
1075 W. LAMBERT RD. SE DECISION MADE: 13-MAR-03
BUILDING D 510(k) SUMMARY AVAILABLE FROM FDA
BREA, CA 92821
DEVICE: ATAC PAK ALBUMIN REAGENT
ELAN DIAGNOSTICS 510(k) NO: K030006(TRADITIONAL)
ATTN: WYNN STOCKING PHONE NO : 714-672-3553
1075 W. LAMBERT RD., SUITE D SE DECISION MADE: 07-MAR-03
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATAC PAK MAGNESIUM REAGENT
ELAN DIAGNOSTICS 510(k) NO: K030010(TRADITIONAL)
ATTN: WYNN STOCKING PHONE NO : 714-672-3553
1075 W. LAMBERT RD., SUITE D SE DECISION MADE: 10-MAR-03
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATAC PAK PHOSPHORUS REAGENT
ELAN DIAGNOSTICS 510(k) NO: K030015(TRADITIONAL)
ATTN: WYNN STOCKING PHONE NO : 714-672-3553
1075 W. LAMBERT RD., SUITE D SE DECISION MADE: 07-MAR-03
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATAC CALIBRATOR
ELAN DIAGNOSTICS 510(k) NO: K030621(TRADITIONAL)
ATTN: WYNN STOCKING PHONE NO : 714-672-3553
1075 W. LAMBERT RD., SUITE D SE DECISION MADE: 19-MAR-03
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHETICARE POWDER-FREE VINYL EXAMINATION GLOVES
EMERALD MEDICAL, INC. 510(k) NO: K030483(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 06-MAR-03
GREAT NECK, NY 11021 510(k) STATEMENT
DEVICE: SYNTHETICARE POWDERED VINYL EXAMINATION GLOVES
EMERALD MEDICAL, INC. 510(k) NO: K030484(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 06-MAR-03
GREAT NECK, NY 11021 510(k) STATEMENT
DEVICE: NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN
ENAMELITE LLC 510(k) NO: K030859(SPECIAL)
ATTN: PHILLIP PITTS PHONE NO : 931-647-7171
1800 BUSINESS PARK DRIVE SE DECISION MADE: 27-MAR-03
SUITE 406 510(k) SUMMARY AVAILABLE FROM FDA
CLARKSVILLE, TN 37040
DEVICE: MS PAED-BABY BODY
ERICH JAEGER GMBH 510(k) NO: K023796(SPECIAL)
ATTN: EARL DRAPER PHONE NO : 714-283-2228
22705 SAVI RANCH PARKWAY SE DECISION MADE: 03-MAR-03
YORBA LINDA, CA 92887-4645 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESKA MODULAR HIP SYSTEM ACETABULAR COMPONENTS
ESKA AMERICA CORP. 510(k) NO: K021878(TRADITIONAL)
ATTN: THOMAS P MONKUS PHONE NO : 941-744-5400
101 RIVERFRONT BLVD. SE DECISION MADE: 04-MAR-03
BRADENTON, FL 34205-8802 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MOD
ETHICON ENDO-SURGERY, INC. 510(k) NO: K030411(TRADITIONAL)
ATTN: CAROL SPRINKLE PHONE NO : 513-337-3792
4545 CREEK RD. SE DECISION MADE: 20-MAR-03
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUVANCE PLUS SAFETY IV CATHETER, PROTECTIV PLUS SAFETY IV CATHE
ETHICON ENDO-SURGERY, INC. 510(k) NO: K030571(TRADITIONAL)
ATTN: KATIE FORDYCE PHONE NO : 513-337-8995
4545 CREEK RD. SE DECISION MADE: 28-MAR-03
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORIA CERVICAL PLATES
EUROSURGICAL S.A. 510(k) NO: K023377(TRADITIONAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LANE SUITE C-100 SE DECISION MADE: 04-MAR-03
PLEASANT HILL, CA 94529 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORIA ZENITH
EUROSURGICAL S.A. 510(k) NO: K030500(SPECIAL)
ATTN: KAREN E WARDEN, MEBE PHONE NO : 304-598-0525
7000 HAMPTON CENTER SE DECISION MADE: 20-MAR-03
SUITE G1 510(k) SUMMARY AVAILABLE FROM FDA
MORGANTOWN, WV 26505
DEVICE: AUDIOSCREENER OAE+ABR
EVEREST BIOMEDICAL INSTRUMENTS CO.510(k) NO: K024205(TRADITIONAL)
ATTN: RANDALL KROHN PHONE NO : 636-519-7770
16690 SWINGLEY RIDGE RD. SE DECISION MADE: 07-MAR-03
SUITE 140 510(k) SUMMARY AVAILABLE FROM FDA
CHESTERFIELD, MO 63017
DEVICE: EXEL BUTTERFLY SCALP VEIN SET
EXELINT INTERNATIONAL CO. 510(k) NO: K020189(TRADITIONAL)
ATTN: TAMMIE EWING PHONE NO : 310-649-0707
5840 W. CENTINELA AVENUE SE DECISION MADE: 27-MAR-03
LOS ANGELES, CA 90231-3194 510(k) STATEMENT
DEVICE: SURGICAL PATIENT WARMER, MODEL PW820 JHU
FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K022609(TRADITIONAL)
ATTN: ROBERT PETRY PHONE NO : 011 649 5740100
15 MAURICE PAYKEL PLACE SE DECISION MADE: 06-MAR-03
EAST TAMAKI 510(k) SUMMARY AVAILABLE FROM FDA
AUCKLAND, NEW ZEALAND
DEVICE: FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS
FRESENIUS MEDICAL CARE 510(k) NO: K023162(TRADITIONAL)
ATTN: NICHOLE RIEK PHONE NO : 781-402-9785
95 HAYDEN AVE SE DECISION MADE: 20-MAR-03
LEXINGTON, MA 02420 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STA
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K022412(TRADITIONAL)
ATTN: ARTHUR E EILINSFELD PHONE NO : 781-402-9068
95 HAYDEN AVE. SE DECISION MADE: 05-MAR-03
LEXINGTON, MA 02420-9192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEM
FRIADENT GMBH 510(k) NO: K024004(SPECIAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900
21911 ERIE LANE SE DECISION MADE: 03-MAR-03
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM
GE MEDICAL SYSTEMS 510(k) NO: K030420(SPECIAL)
ATTN: JOHN W JAECKLE PHONE NO : 262-312-7358
3000 NORTH GRANDVIEW BLVD. SE DECISION MADE: 10-MAR-03
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SOLAR 9500 INFORMATION MONITOR
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K030575(SPECIAL)
ATTN: ANDREW KLUESSENDORF PHONE NO : 414-362-3063
8200 WEST TOWER AVE. SE DECISION MADE: 21-MAR-03
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3.0T TORSO PHASED ARRAY COIL
GE MEDICAL SYSTEMS, INC. 510(k) NO: K030495(TRADITIONAL)
ATTN: LARRY KROGER PHONE NO : 262-544-3894
P.O. BOX 414 SE DECISION MADE: 05-MAR-03
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM
GE OEC MEDICAL SYSTEMS 510(k) NO: K024012(TRADITIONAL)
ATTN: JEFF WAGNER PHONE NO : 801-536-4668
384 WRIGHT BROTHERS DR. SE DECISION MADE: 20-MAR-03
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM
GENERAL ELECTRIC CO. 510(k) NO: K030874(SPECIAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
P.O. BOX 414 SE DECISION MADE: 28-MAR-03
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE VINYL EXAM GLOVES WITH ALOE COATING INSIDE
GENERAL GLOVES CORP. 510(k) NO: K024338(TRADITIONAL)
ATTN: JOHN CHEN PHONE NO : 886 6 6803675
25 PEI MA, 16 LIN TUNG CHUNG SE DECISION MADE: 03-MAR-03
VILLAGE, TUNG SHAN HSIANG 510(k) STATEMENT
TAINAN HSIEN, CHINA (TAIWAN) 733
DEVICE: GENICON CLIP APPLIER
GENICON, LC 510(k) NO: K030269(TRADITIONAL)
ATTN: FRANK GOLDFARB PHONE NO : 407-616-3019
P.O. BOX 780038 SE DECISION MADE: 20-MAR-03
ORLANDO, FL 32878-0038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE
GENZYME BIOSURGERY 510(k) NO: K030212(TRADITIONAL)
ATTN: STEVE PAGE PHONE NO : 508-677-6600
600 AIRPORT RD. SE DECISION MADE: 27-MAR-03
FALL RIVER, MA 02720-4740 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING
GISH BIOMEDICAL, INC. 510(k) NO: K023381(TRADITIONAL)
ATTN: J. HARVEY KNAUSS PHONE NO : 713-723-4080
11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 31-MAR-03
HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GISH ARTERIAL FILTER WITH GBS COATING
GISH BIOMEDICAL, INC. 510(k) NO: K023833(TRADITIONAL)
ATTN: J. HARVEY KNAUSS PHONE NO : 713-723-4080
11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 31-MAR-03
HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING
GISH BIOMEDICAL, INC. 510(k) NO: K024065(TRADITIONAL)
ATTN: J HARVEY KNAUSS PHONE NO : 713-723-4080
11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 05-MAR-03
HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GISH TUBING AND CONNECTORS WITH GBS COATING
GISH BIOMEDICAL, INC. 510(k) NO: K030077(TRADITIONAL)
ATTN: J. HARVEY KNAUSS PHONE NO : 713-723-4080
11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 14-MAR-03
HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CIMOFLUOR
GLOBAL DENTAL PRODUCTS, INC. 510(k) NO: K023888(TRADITIONAL)
ATTN: JERRY L BARTICK PHONE NO : 516-221-8844
PO BOX 537 SE DECISION MADE: 05-MAR-03
NORTH BELLMORE, NY 11710 510(k) STATEMENT
DEVICE: LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9
GLOBAL PROTECTION CORP. 510(k) NO: K024324(ABBREVIATED)
ATTN: DAVIN T WEDEL PHONE NO : 617-946-2800
12 CHANNEL ST. SE DECISION MADE: 25-MAR-03
BOSTON, MA 02210 510(k) STATEMENT
DEVICE: STANDARD THERMOMETER
GLOBAL TREASURE INDUSTRIES LTD. 510(k) NO: K030658(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808
163 CABOT STREET SE DECISION MADE: 25-MAR-03
BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SELF SEAL STERILIZATION POUCH
GRANTON MEDICAL LTD. 510(k) NO: K023025(TRADITIONAL)
ATTN: E. J. SMITH PHONE NO : 410-451-0639
PO BOX 4341 SE DECISION MADE: 04-MAR-03
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: GYRUS PLASMA SKIN RESURFACING SYSTEM
GYRUS MEDICAL, INC. 510(k) NO: K023111(TRADITIONAL)
ATTN: MARK JENSEN PHONE NO : 763-416-3005
6655 WEDGWOOD ROAD SE DECISION MADE: 13-MAR-03
SUITE 105 510(k) SUMMARY AVAILABLE FROM FDA
MAPLE GROVE, MN 55311-3602
DEVICE: CRYOPROBE
H&O; EQUIPMENTS NV/SA 510(k) NO: K024009(TRADITIONAL)
ATTN: LEWIS WARD PHONE NO : 303-530-3279
4655 KIRKWOOD CT. SE DECISION MADE: 20-MAR-03
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82)
HITACHI CHEMICAL DIAGNOSTICS, INC.510(k) NO: K030590(SPECIAL)
ATTN: MARY ANN DU BROCK PHONE NO : 650-961-5501
630 CLYDE CT. SE DECISION MADE: 21-MAR-03
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES
HOME CARE TECHNOLOGY CO., LTD. 510(k) NO: K022917(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 04-MAR-03
POSTAL CODE 300 510(k) STATEMENT
HSIN-CHU CITY, CHINA (TAIWAN) 300
DEVICE: GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER
HOWMEDICA OSTEONICS CORP. 510(k) NO: K023692(TRADITIONAL)
ATTN: MARGARET F CROWE PHONE NO : 201-831-5580
59 ROUTE 17 SE DECISION MADE: 20-MAR-03
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA
HYCOR BIOMEDICAL LTD. 510(k) NO: K030397(TRADITIONAL)
ATTN: DANIELLE M KNIGHT PHONE NO : 44 131 4457111
PENTLANDS SCIENCE PARK SE DECISION MADE: 21-MAR-03
BUSH LOAN 510(k) STATEMENT
EDINBURGH, UNITED KINGDOM EH26 OPL
DEVICE: EXPRESS BLOOD GLUCOSE MONITORING SYSTEM
HYPOGUARD USA, INC. 510(k) NO: K024347(TRADITIONAL)
ATTN: BRUCE A MACFARLANE PHONE NO : 952-646-3188
5182 WEST 76TH ST. SE DECISION MADE: 28-MAR-03
MINNEAPOLIS, MN 55439 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000
IMAGE-GUIDED NEUROLOGICS, INC. 510(k) NO: K024201(TRADITIONAL)
ATTN: DAVID M LEE PHONE NO : 321-309-8237
2290 EAU GALLIE BLVD. SE DECISION MADE: 12-MAR-03
MELBOURNE, FL 32935 510(k) STATEMENT
DEVICE: IM2001 PULSE OXIMETER
IMAGYN MEDICAL TECHNOLOGIES, INC. 510(k) NO: K012706(TRADITIONAL)
ATTN: SANDRA COHEN KALTER PHONE NO : 202-626-2944
1730 PENNSYLVANIA AVE., NW SE DECISION MADE: 07-MAR-03
WASHINGTON, DC 20006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IGLIDE MANUAL ASSIST WHEELCHAIR
INDEPENDENCE TECHNOLOGY, L.L.C. 510(k) NO: K030250(TRADITIONAL)
ATTN: JAMES P O'DONNELL PHONE NO : 908-412-2266
40 TECHNOLOGY DRIVE SE DECISION MADE: 04-MAR-03
P.O. BOX 4917 510(k) SUMMARY AVAILABLE FROM FDA
WARREN, NJ 07059-4917
DEVICE: MODIFICATION TO NASAL-AIRE
INOMED TECHNOLOGIES INC 510(k) NO: K022465(TRADITIONAL)
ATTN: MARGE WALLS-WALKER PHONE NO : 800-593-4654
2934 HIGHWAY 601 NORTH SE DECISION MADE: 21-MAR-03
MOCKSVILLE, NC 27028 510(k) STATEMENT
DEVICE: QUANTA LITE H.PYLORI IGA ELISA
INOVA DIAGNOSTICS, INC. 510(k) NO: K024334(TRADITIONAL)
ATTN: BRYS C MYERS PHONE NO : 619-586-9900
10180 SCRIPPS RANCH BLVD. SE DECISION MADE: 27-MAR-03
SAN DIEGO, CA 92131 510(k) STATEMENT
DEVICE: ACRYLIC
INOVATIV, LLC 510(k) NO: K024282(TRADITIONAL)
ATTN: ROBERT BOWERS PHONE NO : 503-585-4362
1155 TWIN HILLS DRIVE SE DECISION MADE: 21-MAR-03
JEFFERSON, OR 97352 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOSIL FACTOR XI DEFICIENT PLASMA
INSTRUMENTATION LABORATORY CO. 510(k) NO: K030287(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 19-MAR-03
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEOAE25
INTERACOUSTICS A/S, ASSENS 510(k) NO: K030016(TRADITIONAL)
ATTN: DANIEL EGGAN PHONE NO : 952-941-4200
9675 WEST 76TH STREET SE DECISION MADE: 28-MAR-03
EDEN PRAIRIE, MN 55344 510(k) STATEMENT
DEVICE: POWDER-FREE RADIATION ATTENUATING NEOPRENE SURGICAL GLOVE (BLACK
INTERNATIONAL BIOMEDICAL, INC. 510(k) NO: K022873(TRADITIONAL)
ATTN: AMY R PIEPER PHONE NO : 512-873-0033
8508 CROSS PARK DR. SE DECISION MADE: 21-MAR-03
AUSTIN, TX 78754 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IRRIGATION SETS
INTERNATIONAL MEDSURG CONNECTION 510(k) NO: K023808(TRADITIONAL)
ATTN: MICHELE H VOVOLKA PHONE NO : 847-856-0355
P.O. BOX 848 SE DECISION MADE: 10-MAR-03
GRAYSLAKE, IL 60030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3
INVACARE CORP. 510(k) NO: K030814(TRADITIONAL)
ATTN: RAE ANN FARROW PHONE NO : 440-329-6356
ONE INVACARE WAY SE DECISION MADE: 20-MAR-03
P.O. BOX 4028 510(k) SUMMARY AVAILABLE FROM FDA
ELYRIA, OH 44036
DEVICE: TITANIUM OSSICULAR REPLACMENT SYSTEM
INVOTEC INTERNATIONAL, INC. 510(k) NO: K030492(TRADITIONAL)
ATTN: JEFFREY L AULL PHONE NO : 904-880-1229
6833 PHILLIPS INDUSTRIAL BLVD. SE DECISION MADE: 03-MAR-03
JACKSONVILLE, FL 32256-3029 510(k) STATEMENT
DEVICE: IQTEQ SPIROMETER
IQTEQ DEVELOPMENT 510(k) NO: K020102(TRADITIONAL)
ATTN: RAY WRIGHT PHONE NO : 272 142 222222
JAGA HOSE, 61 WALE STREET SE DECISION MADE: 21-MAR-03
CAPE TOWN, WESTERN CAPE, SOUTH AFR510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAWRENCE CSERION, MODEL CS-1
ISORAY, INC 510(k) NO: K030162(ABBREVIATED)
ATTN: DAVID SWANBERG PHONE NO : 509-375-1202
350 HILLS STREET SE DECISION MADE: 28-MAR-03
SUITE 106 510(k) SUMMARY AVAILABLE FROM FDA
RICHLAND, WA 99352
DEVICE: GRAVITECH TM FLOW CONTROLLER PRIMARY SET/GRAVITECH FLOW CONTROLL
IV MEDICAL, INC. 510(k) NO: K030467(TRADITIONAL)
ATTN: MICHAEL G SIMON PHONE NO : 760-635-1761
7854 SITIO COCO SE DECISION MADE: 14-MAR-03
CARLSBAD, CA 92009 510(k) STATEMENT
DEVICE: IVD CRYPTO/GIARDIA DFA
IVD RESEARCH, INC. 510(k) NO: K024113(TRADITIONAL)
ATTN: DAVE LAMBILLOTTE PHONE NO : 760-929-7744
5909 SEA LION PLACE, SUITE D SE DECISION MADE: 05-MAR-03
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: JI-EE ELECTRIC SCOOTER, ELEGANCE ES 3
JI-EE INDUSTRY CO., LTD. 510(k) NO: K024329(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 21-MAR-03
HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680;
JOMED AG 510(k) NO: K030053(TRADITIONAL)
ATTN: TERRY SCHULTZ PHONE NO : 858-673-0189
15330 AVENUE OF SCIENCE SE DECISION MADE: 31-MAR-03
SAN DIEGO, CA 92128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE
KAOHSIUNG BROTHERS PRODUCTS CORP. 510(k) NO: K030200(TRADITIONAL)
ATTN: CHIEN LIN PHONE NO : 773-327-2054
2631, N. MAGNOLIA STREET SE DECISION MADE: 20-MAR-03
CHICAGO, IL 60614 510(k) STATEMENT
DEVICE: KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K030368(TRADITIONAL)
ATTN: MARIO T MARCELO PHONE NO : 310-410-2732
600 CORPORATE POINTE 5TH FLOOR SE DECISION MADE: 20-MAR-03
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KAVO EVEREST TITANBLANK
KAVO AMERICA 510(k) NO: K024214(TRADITIONAL)
ATTN: JOHN R FRANZ PHONE NO : 800-323-8029
340 EAST MAIN STREET SE DECISION MADE: 12-MAR-03
LAKE ZURICH, IL 60047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KENDRO HERACELL 240 INCUBATOR
KENDRO LABORATORY PRODUCTS, L.P. 510(k) NO: K023465(TRADITIONAL)
ATTN: JOSEPH M AZARY PHONE NO : 203-944-9320
P.O. BOX 2156 SE DECISION MADE: 10-MAR-03
HUNTINGTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARFIL SILANE KIT
KURARAY MEDICAL INC. 510(k) NO: K024356(TRADITIONAL)
ATTN: MASAYA SASAKI PHONE NO : 212-986-2230
101 EAST 52ND STREET, 26TH FL. SE DECISION MADE: 26-MAR-03
NEW YORK, NY 10022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKINTACT ECG TAB ELECTRODE
LEONHARD LANG GMBH 510(k) NO: K030509(SPECIAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035
P.O. BOX 560 SE DECISION MADE: 04-MAR-03
STILLWATER, MN 55082-0560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL
LEVITRONIX LLC. 510(k) NO: K020271(ABBREVIATED)
ATTN: FARZAD PARSAIE PHONE NO : 781-622-5075
85 FIRST AVE. SE DECISION MADE: 25-MAR-03
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RMO PLASMA CURING LIGHT
LOKKI LASERS MEDICAUX 510(k) NO: K024374(TRADITIONAL)
ATTN: HILLARD W WELCH PHONE NO : 508-775-5567
344 ANNABELLE POINT ROAD SE DECISION MADE: 10-MAR-03
CENTERVILLE, MA 02632-2402 510(k) STATEMENT
DEVICE: MULTICARE PLATINUM SYSTEM AND ACCESSORIES
LORAD, A HOLOGIC CO. 510(k) NO: K030666(SPECIAL)
ATTN: GAIL YAEKER-DAUNIS PHONE NO : 203-731-8337
36 APPLE RIDGE RD. SE DECISION MADE: 25-MAR-03
DANBURY, CT 06810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUC
LSI SOLUTIONS 510(k) NO: K024301(TRADITIONAL)
ATTN: CHRISTOPHER A KLACZYK PHONE NO : 585-869-6600
7796 VICTOR-MENDON RD. SE DECISION MADE: 24-MAR-03
VICTOR, NY 14564 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAS LIPID LEVEL 1 AND 2
MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K030679(TRADITIONAL)
ATTN: PENNY M LAYMAN PHONE NO : 805-987-7891
5300 ADOLFO RD. SE DECISION MADE: 14-MAR-03
CAMARILLO, CA 93012 510(k) STATEMENT
DEVICE: MSI TA ELECTRODES
MEDSPHERE INTERNATIONAL, INC 510(k) NO: K024266(TRADITIONAL)
ATTN: ERIC KAO PHONE NO : 510-656-8232
48511 WARM SPRINGS BLVD SE DECISION MADE: 12-MAR-03
SUITE 212 510(k) STATEMENT
FREMONT, CA 94539
DEVICE: VERTE-STACK SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K030601(SPECIAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 25-MAR-03
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM
MEDTRONIC SURGICAL NAVIGATION TECH510(k) NO: K030552(SPECIAL)
ATTN: VICTORIA G RENDON PHONE NO : 720-890-3200
826 COAL CREEK CIRCLE SE DECISION MADE: 19-MAR-03
LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO EXPORT ASPIRATION CATHETER
MEDTRONIC, INC. 510(k) NO: K030201(SPECIAL)
ATTN: FRED L BOUCHER PHONE NO : 978-777-0042
37A CHERRY HILL DRIVE SE DECISION MADE: 26-MAR-03
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NMA 1052 CONSOLE SYSTEM WITH NMA 100 LASER ACCESSORY
MEDX ELECTRONICS, INC. 510(k) NO: K024310(TRADITIONAL)
ATTN: ANITA SALTMARCHE PHONE NO : 888 363 3112
3535 LAIRD RD., UNIT 2 SE DECISION MADE: 24-MAR-03
MISSISSAUGA, ONTARIO, CANADA L5L 5510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS
MENTOR MEDICAL LIMITED 510(k) NO: K022212(TRADITIONAL)
ATTN: STEVE OGILVIE PHONE NO : 440 130 3208011
MILITARY ROAD SE DECISION MADE: 21-MAR-03
HYTHE, KENT, UNITED KINGDOM CT21 6510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VECTORSURGE 5 MODEL 470
METRON MEDICAL AUSTRALIA P/L 510(k) NO: K030648(SPECIAL)
ATTN: DAVE TOMAN PHONE NO : 613 977 51234
57 ASTER AVE. SE DECISION MADE: 28-MAR-03
CARRUM DOWNS, VICTORIA, AUSTRALIA 510(k) STATEMENT
DEVICE: ACCOUSONIC, MODEL AS-270
METRON MEDICAL AUSTRALIA, PTY, LTD510(k) NO: K030878(SPECIAL)
ATTN: DAVE TOMAN PHONE NO : 613 977 51234
57 ASTER AVE., P.O. BOX 2164 SE DECISION MADE: 28-MAR-03
CARRUM DOWNS, VICTORIA, AUSTRALIA 510(k) STATEMENT
DEVICE: MHS 7000
MICRO HEALTH SYSTEMS INC. 510(k) NO: K030018(TRADITIONAL)
ATTN: ROBERT BARNES PHONE NO : 954-575-1076
7407 DOVER LANE SE DECISION MADE: 26-MAR-03
PARKLAND, FL 33067 510(k) STATEMENT
DEVICE: NAUTICA MICRO CATHETER, MODEL 105-5094-153
MICRO THERAPEUTICS, INC. 510(k) NO: K024122(TRADITIONAL)
ATTN: MARILYN R POURAZAR PHONE NO : 949-837-3700
2 GOODYEAR SE DECISION MADE: 07-MAR-03
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHELON MICRO CATHETER, MODEL 105-5092-150
MICRO THERAPEUTICS, INC. 510(k) NO: K030688(SPECIAL)
ATTN: MARILYN R POURAZAR PHONE NO : 949-837-3700
2 GOODYEAR SE DECISION MADE: 28-MAR-03
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5
MICROGENICS CORP. 510(k) NO: K030616(TRADITIONAL)
ATTN: RUEYMING LOOR PHONE NO : 510-979-5151
46360 FREMONT BLVD. SE DECISION MADE: 31-MAR-03
FREMONT, CA 94538 510(k) STATEMENT
DEVICE: MIDMARK M9 ULTRACLAVE STEAM STERILIZER
MIDMARK CORP. 510(k) NO: K023348(TRADITIONAL)
ATTN: GENE JARSHNARGER PHONE NO : 937-526-8297
60 VISTA DR. SE DECISION MADE: 03-MAR-03
P.O. BOX 286 510(k) SUMMARY AVAILABLE FROM FDA
VERSAILLES, OH 45380
DEVICE: MODEL 1300GE-64: PEDIATRIC POSITIONER
MIDWEST R.F. LLC. 510(k) NO: K030317(TRADITIONAL)
ATTN: HELMUT KEIDL PHONE NO : 262-367-6925
535 NORTON DR. SE DECISION MADE: 25-MAR-03
HARTLAND, WI 53029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROFIX QUICKANCHOR PLUS
MITEK WORLDWIDE 510(k) NO: K024115(TRADITIONAL)
ATTN: RUTH C FORSTADT PHONE NO : 781-251-3188
249 VANDERBILT AVENUE SE DECISION MADE: 13-MAR-03
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRUEZONE PEAK FLOW METER
MONAGHAN MEDICAL CORP. 510(k) NO: K023097(ABBREVIATED)
ATTN: JAMES A COCHIE PHONE NO : 518-561-7330
5 LATOUR AVE., SUITE 1600 SE DECISION MADE: 07-MAR-03
P.O. BOX 2805 510(k) STATEMENT
PLATTSBURGH, NY 12901
DEVICE: FYRELINK
MPACS, LLC. 510(k) NO: K030242(TRADITIONAL)
ATTN: GREG SOPOTNICK PHONE NO : 608-827-7111
7601 GANSER WAY SE DECISION MADE: 10-MAR-03
MADISON, WI 53719 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORAMAGICRX ORAL WOUND RINSE
MPM MEDICAL, INC. 510(k) NO: K024180(TRADITIONAL)
ATTN: RICHARD A HAMER PHONE NO : 734-697-4601
48910 DENTON RD., #38 SE DECISION MADE: 14-MAR-03
BELLEVILLE, MI 48111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODULEAF
MRC SYSTEMS GMBH 510(k) NO: K030609(SPECIAL)
ATTN: JOERG STEIN PHONE NO : 496 221 1380300
HANS-BUNTE-STR. 10 SE DECISION MADE: 17-MAR-03
HEIDELBERG, GERMANY D-69123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SUZANNE PORTABLE POLYSOMNOGRAPH SYSTEM
NELLCOR PURITAN BENNETT (MELVILLE)510(k) NO: K030611(SPECIAL)
ATTN: ROB MATHESON PHONE NO : 613 238 1840
400-303 TERRY FOX DRIVE SE DECISION MADE: 24-MAR-03
KANATA, ONTARIO, CANADA K2K 3J1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A
NIHON KOHDEN AMERICA, INC. 510(k) NO: K030105(TRADITIONAL)
ATTN: SERRAH NAMINI PHONE NO : 949-580-1555
90 ICON STREET SE DECISION MADE: 04-MAR-03
FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVASIVE MASH
NUVASIVE, INC. 510(k) NO: K023319(TRADITIONAL)
ATTN: LAETITIA BERNARD PHONE NO : 858-527-1918
10065 OLD GROVE RD., SUITE A SE DECISION MADE: 04-MAR-03
SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE OBSIDIAN PACS SYSTEM
OBSIDIAN MEDICAL TECHNOLOGY, INC. 510(k) NO: K030635(TRADITIONAL)
ATTN: BIANCA GREEN PHONE NO : 925-426-3111
5108 CORONA CT. SE DECISION MADE: 28-MAR-03
PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE
OLYMPUS OPTICAL CO., LTD. 510(k) NO: K024138(TRADITIONAL)
ATTN: TINA STEFFANIC-OAK PHONE NO : 631-844-5688
TWO CORPORATE CENTER DRIVE SE DECISION MADE: 12-MAR-03
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CROSSEAL APPLICATION DEVICE
OMRIX BIOPHARMACEUTICALS, INC. 510(k) NO: K030032(TRADITIONAL)
ATTN: SUE BHADARE PHONE NO : 540-428-2828
6599 COMMERCE COURT SE DECISION MADE: 21-MAR-03
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
WARRINGTON, VA 20187
DEVICE: OTI SCAN WITH TRANSDUCERS
OPHTHALMIC TECHNOLOGIES, INC. 510(k) NO: K030770(SPECIAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 RT 17 S SE DECISION MADE: 27-MAR-03
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTION-VF URINARY CATHETER, FV14218
OPTICON MEDICAL, INC. 510(k) NO: K023090(TRADITIONAL)
ATTN: GLENN D BRUNNER PHONE NO : 614-336-2000
7001 POST RD. SE DECISION MADE: 19-MAR-03
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
DUBLIN, OH 43016
DEVICE: EXPRESS MINI GLAUCOMA SHUNT
OPTONOL, LTD 510(k) NO: K030350(ABBREVIATED)
ATTN: PENNY NORTHCUTT PHONE NO : 678-415-3214
SURGICAL BUSINESS UNIT SE DECISION MADE: 13-MAR-03
11460 JOHNS CREEK PARKWAY 510(k) SUMMARY AVAILABLE FROM FDA
DULUTH, GA 30097
DEVICE: HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME
ORASURE TECHNOLOGIES, INC. 510(k) NO: K023487(TRADITIONAL)
ATTN: R. SAM NIEDBALA PHONE NO : 610-882-1820
150 WEBSTER ST SE DECISION MADE: 20-MAR-03
BETHELEHEM, PA 18015-1389 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFESTENT BILIARY ENDOPROSTHESIS
ORBUS MEDICAL TECHNOLOGIES 510(k) NO: K023121(TRADITIONAL)
ATTN: JIM CLOSSICK PHONE NO : 954-730-0711
5363 N.W. 35TH AVE. SE DECISION MADE: 10-MAR-03
FT. LAUDERDALE, FL 33309-6315 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K030626(SPECIAL)
ATTN: DARLENE J PHILLIPS PHONE NO : 585-453-4253
100 INDIGO CREEK DR. SE DECISION MADE: 18-MAR-03
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMBIBE BONE MARROW ASPIRATION SYRINGE
ORTHOVITA, INC. 510(k) NO: K023074(SPECIAL)
ATTN: ANDREINA IDE PHONE NO : 610-407-5231
45 GREAT VALLEY PKWY. SE DECISION MADE: 11-MAR-03
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSSE-LIGN
OSSEUS, LLC 510(k) NO: K023564(TRADITIONAL)
ATTN: SHAWN T HUXEL PHONE NO : 908-997-0127
34 WOODLANE ROAD SE DECISION MADE: 11-MAR-03
LAWRENCEVILLE, NJ 08648 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-0
OSTEOBIOLOGICS, INC. 510(k) NO: K024199(TRADITIONAL)
ATTN: GABRIELE G NIEDERAUER PHONE NO : 210-690-2131
UNIVERSITY BUSINESS PARK SE DECISION MADE: 14-MAR-03
12500 NETWORK, SUITE 112 510(k) SUMMARY AVAILABLE FROM FDA
SAN ANTONIO, TX 78249-3308
DEVICE: MODIFICATION TO PLEXOLONG SETS
PAJUNK GMBH 510(k) NO: K023218(SPECIAL)
ATTN: BURK BRANDT PHONE NO : 541-752-3953
5010 NW CRESCENT VALLEY DRIVE SE DECISION MADE: 24-MAR-03
CORVALLIS, OR 97330 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUS
PALL CORP. 510(k) NO: K022167(TRADITIONAL)
ATTN: LEONARD S BERMAN PHONE NO : 516-801-9059
2200 NORTHERN BLVD. SE DECISION MADE: 07-MAR-03
EAST HILLS, NY 11548 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRACERS BONE CEMENT OPACIFIER
PARALLAX MEDICAL, INC. 510(k) NO: K023445(SPECIAL)
ATTN: LINDA BRADLEY PHONE NO : 831-439-0130
940 DISC DR. SE DECISION MADE: 11-MAR-03
SCOTTS VALLEY, CA 95066-4544 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIBERFILL SGP
PENTRON CLINICAL TECHNOLOGIES 510(k) NO: K023819(TRADITIONAL)
ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397
53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 26-MAR-03
WALLINGFORD, CT 06492-0724 510(k) STATEMENT
DEVICE: PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00
PEREGRINE SURGICAL LTD. 510(k) NO: K024061(TRADITIONAL)
ATTN: TODD RICHMOND PHONE NO : 215-348-0456
51 BRITAIN DR. SE DECISION MADE: 07-MAR-03
NEW BRITAIN, PA 18901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CCD CAMERA, MODEL PKP-06000-000
PERKINS ELECTRONICS CO. 510(k) NO: K024085(TRADITIONAL)
ATTN: JIM FURSE PHONE NO : 214-828-4545
1510 N.WASHINGTON AVENUE SE DECISION MADE: 11-MAR-03
DALLAS, TX 75204-5297 510(k) STATEMENT
DEVICE: ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS
PERUSAHAAN GETAH ASAS SDN BHD 510(k) NO: K030331(TRADITIONAL)
ATTN: JAMES F LOGAN PHONE NO : 410-837-1751
1301 DEFENCE HIGHWAY SE DECISION MADE: 21-MAR-03
GAMBRILLS, MD 21054 510(k) STATEMENT
DEVICE: LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROT
PERUSAHAAN GETAH ASAS SDN BHD 510(k) NO: K030333(TRADITIONAL)
ATTN: JAMES F LOGAN PHONE NO : 410-837-1751
1301 DEFENCE HIGHWAY SE DECISION MADE: 21-MAR-03
GAMBRILLS, MD 21054 510(k) STATEMENT
DEVICE: ON-LINE POWDER-FREE NITRILE EXAMINATION GLOVE, VIOLET COLORED
PERUSAHAAN GETAH ASAS SDN BHD 510(k) NO: K030335(TRADITIONAL)
ATTN: JAMES F LOGAN PHONE NO : 410-837-1751
1301 DEFENCE HIGHWAY SE DECISION MADE: 03-MAR-03
GAMBRILLS, MD 21054 510(k) STATEMENT
DEVICE: INTERA FAMILY
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K030520(TRADITIONAL)
ATTN: LYNN HARMER PHONE NO : 425-487-7312
22100 BOTHELL EVERETT HWY. SE DECISION MADE: 06-MAR-03
P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98041-3003 THIRD PARTY REVIEW
DEVICE: PHILIPS MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS WITH POR
PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K030038(SPECIAL)
ATTN: DAVID OSBORN PHONE NO : 978-659-3178
3000 MINUTEMAN RD SE DECISION MADE: 12-MAR-03
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M2376A DEVICELINK SYSTEM
PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K030731(SPECIAL)
ATTN: HERBERT VAN DYK PHONE NO : 497 031 4631734
HEWLETT PACKARD STR. 2 SE DECISION MADE: 21-MAR-03
BOBLINGEN, GERMANY D71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM
PHILIPS ULTRASOUND, INC. 510(k) NO: K030455(TRADITIONAL)
ATTN: LYNN HARMER PHONE NO : 425-487-7312
22100 BOTHELL EVERETT HWY. SE DECISION MADE: 13-MAR-03
P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98041 THIRD PARTY REVIEW
DEVICE: G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE
POINTE SCIENTIFIC, INC. 510(k) NO: K024006(TRADITIONAL)
ATTN: RON JAMISON PHONE NO : 800-445-9853
1025 JOHN A. PAPALAS DR. SE DECISION MADE: 31-MAR-03
LINCOLN PARK, MI 48146 510(k) STATEMENT
DEVICE: POD PAC-20M
PORTABLE OPHTHALMIC DEVICES, INC. 510(k) NO: K030610(TRADITIONAL)
ATTN: TIM EHRECKE PHONE NO : 563-529-3536
4413 WINSTON PLACE SE DECISION MADE: 21-MAR-03
BETTENDORF, IA 52722 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGASSIST STRAIGHT LINEAR STAPLER AND STRAIGHT LINEAR 4 ROW NO
POWER MEDICAL INTERVENTIONS, INC. 510(k) NO: K030653(SPECIAL)
ATTN: BABARA J WHITMAN PHONE NO : 267-775-8151
110 UNION SQUARE DRIVE SE DECISION MADE: 31-MAR-03
NEW HOPE, PA 18938-1364 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50
PRECISION BIOLOGIC 510(k) NO: K023990(TRADITIONAL)
ATTN: STEPHEN L DUFF PHONE NO : 902 468 6422
900 WINDMILL RD., SUITE 100 SE DECISION MADE: 19-MAR-03
DARTMOUTH, N.S., CANADA B3B 1P7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY
PRECISION SYSTEMS, INC. 510(k) NO: K024182(TRADITIONAL)
ATTN: BILL HADEN PHONE NO : 508-655-7010
16 TECH CIRCLE SE DECISION MADE: 03-MAR-03
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FENESTRATED INFUSION CATHETER
PROMEDIC, INC. 510(k) NO: K024190(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 317-335-3780
6329 WEST WATERVIEW CT. SE DECISION MADE: 17-MAR-03
MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSCOPIC LASER DELIVERY SYSTEM-LASERTX
PROSURG, INC. 510(k) NO: K023257(TRADITIONAL)
ATTN: ASHVIN DESAI PHONE NO : 408-945-4044
2193 TRADE ZONE BLVD. SE DECISION MADE: 28-MAR-03
SAN JOSE, CA 95131 510(k) STATEMENT
DEVICE: POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES
PT. MEDISAFE TECHNOLOGIES 510(k) NO: K030228(TRADITIONAL)
ATTN: ANIL TANEJA PHONE NO : 62 61 4515834
JL. KAPT. PATTIMURA NO. 23 SE DECISION MADE: 14-MAR-03
MEDAN, NORTH SUMATRA, INDONESIA 20510(k) STATEMENT
DEVICE: LATEX EXAMINATION GLOVES POWDER FREE WITH NEOPRENE LINED, SIZES
PT. SHAMROCK MANUFACTURING CORP. 510(k) NO: K030134(TRADITIONAL)
ATTN: EMMY TJOENG PHONE NO : 909-591-8855
5445 DANIELS STREET SE DECISION MADE: 25-MAR-03
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM
PT. SHAMROCK MANUFACTURING CORP. 510(k) NO: K030325(TRADITIONAL)
ATTN: EMMY TJOENG PHONE NO : 909-591-8855
5445 DANIELS STREET SE DECISION MADE: 28-MAR-03
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERFREE LATEX EXAMINATION GLOVES WITH GRAPE
PT. SHAMROCK MANUFACTURING CORP. 510(k) NO: K030560(TRADITIONAL)
ATTN: EMMY TJOENG PHONE NO : 909-591-8855
5445 DANIELS STREET SE DECISION MADE: 21-MAR-03
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES (NATURAL, BLUE,PURPLE)
PT. SMARTGLOVE INDONESIA 510(k) NO: K030284(TRADITIONAL)
ATTN: FOO KHON PU PHONE NO : 006 261 4532926
STAR JL.RAYA MEDAN-LUBUK PAKAM SE DECISION MADE: 25-MAR-03
KM.19, TG.MAROWA B-TG.MAROWA 510(k) STATEMENT
DELI SERDANG,SUMATERA UTARA, INDONESIA 20362
DEVICE: GLOVETEX LATEX EXAMINATION GLOVES, POWDERED, BLUE, NON STERILE
PT. WRP BUANA MULTICORPORA 510(k) NO: K030273(TRADITIONAL)
ATTN: NG POY SIN PHONE NO : 61 694 2461
JALAN JERMAL #20B, KELURAHAN SE DECISION MADE: 26-MAR-03
SEI MATI, MEDAN LABUHAN KM 17 510(k) SUMMARY AVAILABLE FROM FDA
MEDAN, INDONESIA 20252
DEVICE: OPTIDOS
PTW-NEW YORK CORP. 510(k) NO: K010705(TRADITIONAL)
ATTN: STEPHEN R SZEGLIN PHONE NO : 516-827-3181
201 PARK AVE. SE DECISION MADE: 11-MAR-03
HICKSVILLE, NY 11801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT
PULPDENT CORPORATION 510(k) NO: K030036(TRADITIONAL)
ATTN: KENNETH J BERK PHONE NO : 617-926-6666
80 OAKLAND STREET SE DECISION MADE: 12-MAR-03
WATERTOWN, MA 02472 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SETPOINT ENDOVASCULAR TEMPERATURE PROBE
RADIANT MEDICAL 510(k) NO: K024327(TRADITIONAL)
ATTN: ANDREW CLEELAND PHONE NO : 650-363-8000
250 CHESAPEAKE DRIVE SE DECISION MADE: 25-MAR-03
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K022198(TRADITIONAL)
ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY. SE DECISION MADE: 21-MAR-03
VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS
RUSCH INTL. 510(k) NO: K023918(TRADITIONAL)
ATTN: RICK LYKINS PHONE NO : 603-532-0204
50 PLANTATION DRIVE SE DECISION MADE: 28-MAR-03
JAFFERY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAS RSV CONTROL KIT
SA SCIENTIFIC, INC. 510(k) NO: K030628(TRADITIONAL)
ATTN: RICARDO R MARTINEZ PHONE NO : 210-699-8800
4919 GOLDEN QUAIL SE DECISION MADE: 17-MAR-03
SAN ANTONIO, TX 78240 510(k) STATEMENT
DEVICE: AIGIS-PLUS
SB LUCIUS, INC. 510(k) NO: K024135(TRADITIONAL)
ATTN: DAE-KYU CHANG PHONE NO : 714-530-2814
9778 KATELLA AVE. STE. 205 SE DECISION MADE: 10-MAR-03
ANAHEIM, CA 92804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIGIS-SOFT
SB LUCIUS, INC. 510(k) NO: K024136(TRADITIONAL)
ATTN: DAEKYU CHANG PHONE NO : 714-530-2814
9778 KATELLA AVE. STE. 205 SE DECISION MADE: 10-MAR-03
ANAHEIM, CA 92804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIGIS-INLAY
SB LUCIUS, INC. 510(k) NO: K024139(TRADITIONAL)
ATTN: DAE-KYU CHANG PHONE NO : 714-530-2814
9778 KATELLA AVE. STE. 205 SE DECISION MADE: 07-MAR-03
ANAHEIM, CA 92804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIGIS-A
SB LUCIUS, INC. 510(k) NO: K024140(TRADITIONAL)
ATTN: DAE-KYU CHANG PHONE NO : 714-530-2814
9778 KATELLA AVE. STE. 205 SE DECISION MADE: 06-MAR-03
ANAHEIM, CA 92804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEO 76
SB LUCIUS, INC. 510(k) NO: K024141(TRADITIONAL)
ATTN: DAE-KYU CHANG PHONE NO : 714-530-2814
9778 KATELLA AVE. STE. 205 SE DECISION MADE: 06-MAR-03
ANAHEIM, CA 92804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIGIS-SUPER
SB LUCIUS, INC. 510(k) NO: K024142(TRADITIONAL)
ATTN: DAE-KYU CHANG PHONE NO : 714-530-2814
9778 KATELLA AVE. STE. 205 SE DECISION MADE: 10-MAR-03
ANAHEIM, CA 92804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIGIS-FINE
SB LUCIUS, INC. 510(k) NO: K024143(TRADITIONAL)
ATTN: DAE-KYU CHANG PHONE NO : 714-530-2814
9778 KATELLA AVE. STE. 205 SE DECISION MADE: 10-MAR-03
ANAHEIM, CA 92804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIGIS-PT
SB LUCIUS, INC. 510(k) NO: K024144(TRADITIONAL)
ATTN: DAE-KYU CHANG PHONE NO : 714-530-2814
9778 KATELLA AVE. STE. 205 SE DECISION MADE: 07-MAR-03
ANAHEIM, CA 92804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIGIS-XO
SB LUCIUS, INC. 510(k) NO: K024145(TRADITIONAL)
ATTN: DAE-KYU CHANG PHONE NO : 714-530-2814
9778 KATELLA AVE. STE. 205 SE DECISION MADE: 07-MAR-03
ANAHEIM, CA 92804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DSG RELAXER SPLINT
SENTAGE CORPORATION D/B/A/ DENTAL 510(k) NO: K022627(TRADITIONAL)
ATTN: G. BRENT CONNOR PHONE NO : 202-736-2665
1801 K STREET NW SE DECISION MADE: 18-MAR-03
SUITE 1200 510(k) STATEMENT
WASHINGTON, DC 20006
DEVICE: "STAIRFRIEND" CURVED STAIRWAY CHAIRLIFT
SERVICES INDUSTRIELS SAVARIA, INC.510(k) NO: K023852(TRADITIONAL)
ATTN: ANSIS M HELMANIS PHONE NO : 202-457-0300
1225 EYE STREET N.W. SE DECISION MADE: 04-MAR-03
SUITE 1150 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005
DEVICE: THE MULTILIFT
SERVICES INDUSTRIELS SAVARIA, INC.510(k) NO: K024346(TRADITIONAL)
ATTN: STEPHEN W BROPHY PHONE NO : 202-457-0300
1225 EYE STREET N.W. SE DECISION MADE: 04-MAR-03
SUITE 1150 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005
DEVICE: POWDER FREE SYNTHETIC NITRILE NEOPRENE EXAMINATION GLOVES, SIZES
SHAMROCK MANUFACTURING COMPANY 510(k) NO: K030386(TRADITIONAL)
ATTN: EMMY TJOENG PHONE NO : 909-591-8855
5445 DANIELS STREET SE DECISION MADE: 28-MAR-03
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIEMENS INFINITY GATEWAY SUITE, MODEL VF2
SIEMENS MEDICAL SOLUTIONS 510(k) NO: K030657(SPECIAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVENUE SE DECISION MADE: 21-MAR-03
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINITY EXPLORER
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K030615(SPECIAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 21-MAR-03
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILVERLEAF CONTACT WOUND DRESSING
SILVERLEAF TECHNOLOGIES INC 510(k) NO: K013936(TRADITIONAL)
ATTN: ALAN THOMPSON PHONE NO : 613 830 9513
3 WOODBURN DRIVE SE DECISION MADE: 18-MAR-03
OTTAWA, ONTARIO, CANADA K1A3B9 510(k) STATEMENT
DEVICE: MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS
SMITH & NEPHEW, INC. 510(k) NO: K030344(SPECIAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487
1450 E. BROOKS ROAD SE DECISION MADE: 04-MAR-03
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEEDLINKS, MODELS 70301, 70302, 70303
SOURCETECH MEDICAL, L.L.C. 510(k) NO: K023210(TRADITIONAL)
ATTN: DAVID T SIERACKI PHONE NO : 630-933-7615
295 E. LIES RD. SE DECISION MADE: 28-MAR-03
CAROL STREAM, IL 60188 510(k) STATEMENT
DEVICE: SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST
SPECTRAL DIAGNOSTICS, INC. 510(k) NO: K030057(TRADITIONAL)
ATTN: NISAR A SHAIKH PHONE NO : 416 626 3233 X236
135-2 THE WEST MALL SE DECISION MADE: 19-MAR-03
TORONTO, ONTARIO, CANADA M9C1C2 510(k) STATEMENT
DEVICE: SPINAL CONCEPTS INC. PATHFINDER
SPINAL CONCEPTS, INC. 510(k) NO: K030625(SPECIAL)
ATTN: LISA PERTERSON PHONE NO : 512-918-2700
5301 RIATA PARK CT., BLDG. F SE DECISION MADE: 28-MAR-03
AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROVEN MODULAR TIBIAL TRAY
STELKAST COMPANY 510(k) NO: K030577(SPECIAL)
ATTN: DONALD A STEVENS PHONE NO : 724-941-6368
200 HIDDEN VALLEY ROAD SE DECISION MADE: 25-MAR-03
MCMURRAY, PA 15317 510(k) STATEMENT
DEVICE: REPROCESSED PULSE OXIMETER SENSORS
STERILMED, INC. 510(k) NO: K012677(TRADITIONAL)
ATTN: PATRICK FLEISCHHACKER PHONE NO : 888-856-4870
11400 73RD AVE. NORTH SE DECISION MADE: 28-MAR-03
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMSCO CENTURY STEAM STERILIZER
STERIS CORPORATION 510(k) NO: K030789(SPECIAL)
ATTN: LORI HALLER PHONE NO : 814-870-8559
2424 WEST 23RD ST. SE DECISION MADE: 26-MAR-03
ERIE, PA 16514 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONE WIRE
STORK INSTRUMENTE GMBH 510(k) NO: K030665(TRADITIONAL)
ATTN: LORI ADVIDS PHONE NO : 847-856-3851
7046 BENTLY DRIVE SE DECISION MADE: 25-MAR-03
GURNEE, IL 60031 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ITI DENTAL IMPLANT SYSTEM
STRAUMANN USA 510(k) NO: K030007(TRADITIONAL)
ATTN: LINDA JALBERT PHONE NO : 800-448-8168
RESERVOIR PLACE, SE DECISION MADE: 31-MAR-03
1601 TRAPELO ROAD 510(k) SUMMARY AVAILABLE FROM FDA
WALTHAM, MA 02154
DEVICE: STRYKER BIOZIP SUTURE ANCHOR
STRYKER ENDOSCOPY 510(k) NO: K023192(TRADITIONAL)
ATTN: ALISA MILLER PHONE NO : 408-754-2259
5900 OPTICAL CT. SE DECISION MADE: 20-MAR-03
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKERWARE SYSTEM
STRYKER ENDOSCOPY 510(k) NO: K024159(TRADITIONAL)
ATTN: EVAN NORTON PHONE NO : 408-754-2637
5900 OPTICAL CT. SE DECISION MADE: 10-MAR-03
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER LEIBINGER CRANIAL FIXATION SYSTEM
STRYKER INSTRUMENTS 510(k) NO: K030378(TRADITIONAL)
ATTN: WADE T RUTKOSKIE PHONE NO : 269-323-4226
4100 EAST MILHAM AVENUE SE DECISION MADE: 20-MAR-03
KALAMAZOO, MI 49087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUTURTEK FASTCLOSE SUTURING DEVICE
SUTURTEK INCORPORATED 510(k) NO: K030227(TRADITIONAL)
ATTN: DEBBIE IAMPIETRO PHONE NO : 508-259-7374
7 TIFFANY TRAIL SE DECISION MADE: 17-MAR-03
HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMEARCLEAR
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K024198(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 05-MAR-03
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VICTOREEN THEBES II, MODEL 7020
SYNCOR RADIATION MANAGEMENT 510(k) NO: K024284(TRADITIONAL)
ATTN: CHRISTINE G CASTLEBERRY PHONE NO : 800-850-4608
6045 COCHRAN ROAD SE DECISION MADE: 11-MAR-03
SOLON, OH 44139-3303 510(k) STATEMENT
DEVICE: SYNTHES USS, CLICK'X, USS VAS, DUAL-OPENING USS AND SMALL STATUR
SYNTHES (USA) 510(k) NO: K022949(TRADITIONAL)
ATTN: VIKKI M HOFFMAN PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 24-MAR-03
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW)
SYNTHES (USA) 510(k) NO: K024364(TRADITIONAL)
ATTN: JONATHAN GILBERT PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 17-MAR-03
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SYNTHES CERVIFIX SYSTEM
SYNTHES (USA) 510(k) NO: K030377(SPECIAL)
ATTN: VIKKI M HOFFMAN PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 06-MAR-03
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES
SYNTHES (USA) 510(k) NO: K030597(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610-647-9700
P.O. BOX 1766 SE DECISION MADE: 20-MAR-03
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222
DEVICE: URS-1B (BLOOD TEST)
TECO DIAGNOSTICS 510(k) NO: K023297(TRADITIONAL)
ATTN: LISA TO PHONE NO : 714-693-7788
1268 . LAKEVIEW AVE. SE DECISION MADE: 06-MAR-03
ANAHEIM, CA 92807 510(k) STATEMENT
DEVICE: KMEDIC EXTERNAL FIXATION DEVICES
TELEFLEX MEDICAL GROUP 510(k) NO: K030336(TRADITIONAL)
ATTN: RICK LYKINS PHONE NO : 603-532-0204
50 PLANTATION DRIVE SE DECISION MADE: 06-MAR-03
JAFFREY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENSCARE ULTIMA NMS/EMS
TENSCARE LTD. 510(k) NO: K023997(TRADITIONAL)
ATTN: BERNARD J TREMAINE PHONE NO : 440 161 9804310
76 STOCKPORT ROAD SE DECISION MADE: 03-MAR-03
TIMPERLEY, CHESHIRE, UNITED KINGDO510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SY
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K022947(TRADITIONAL)
ATTN: MARK A BUR PHONE NO : 734-741-6117
6200 JACKSON RD. SE DECISION MADE: 20-MAR-03
ANN ARBOR, MI 48103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR
TERUMO CORP. 510(k) NO: K030449(SPECIAL)
ATTN: GARRY A COURTNEY PHONE NO : 800-283-7866
125 BLUE BALL RD SE DECISION MADE: 05-MAR-03
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT
THE BINDING SITE, LTD. 510(k) NO: K030238(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 24-MAR-03
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT
THE OLYMPUS OPTICAL CO. 510(k) NO: K030194(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
ENDOSCOPE DIVISION SE DECISION MADE: 24-MAR-03
TWO CORPORATE CENTER DRIVE 510(k) SUMMARY AVAILABLE FROM FDA
MELVILLE, NY 11747-3157 THIRD PARTY REVIEW
DEVICE: THERIRIDGE BLOCK, BONE GRAFT SUBSTITUTE
THERICS, INC. 510(k) NO: K023998(TRADITIONAL)
ATTN: UMBERTO V PARROTTA PHONE NO : 609-514-7200
115 CAMPUS DRIVE SE DECISION MADE: 26-MAR-03
PRINCETON, NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLU OIA A/B TEST KIT
THERMO BIOSTAR, INC. 510(k) NO: K023556(TRADITIONAL)
ATTN: JOHN G ADAMS PHONE NO : 303-530-3888
331 SOUTH 104 ST. SE DECISION MADE: 27-MAR-03
LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPI ELEMENT DENTAL IMPLANT O 3.5 MM
THOMMEN MEDICAL, AG 510(k) NO: K030689(SPECIAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
4329 GRAYDON ROAD SE DECISION MADE: 26-MAR-03
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TISSUELINK SEALING FORCEPS, MODEL 1 21-202-1
TISSUELINK MEDICAL, INC. 510(k) NO: K030380(SPECIAL)
ATTN: VICKI ANASTASI PHONE NO : 603-742-1515
ONE WASHINGTON CENTER SE DECISION MADE: 03-MAR-03
SUITE #400 510(k) SUMMARY AVAILABLE FROM FDA
DOVER, NH 03820
DEVICE: SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K024353(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-871-8909
982 KEYNOTE CIRCLE SUITE 6 SE DECISION MADE: 06-MAR-03
CLEVELAND, OH 44131 510(k) STATEMENT
DEVICE: SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K024357(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-871-8909
982 KEYNOTE CIRCLE SUITE 6 SE DECISION MADE: 17-MAR-03
CLEVELAND, OH 44131 510(k) STATEMENT
DEVICE: OPTIMA, SPINAL SYSTEM
U&I; CORP., AMERICA 510(k) NO: K024096(TRADITIONAL)
ATTN: PATRICK MOORE PHONE NO : 801-262-3100
6132 SOUTH 380 WEST, SE DECISION MADE: 12-MAR-03
MURRAY, UT 84107-6988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
UNITED STATES SURGICAL, A DIVISION510(k) NO: K024275(TRADITIONAL)
ATTN: SARAH HUBENY PHONE NO : 203-492-5179
150 GLOVER AVE. SE DECISION MADE: 14-MAR-03
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VBL SERUM TROPONIN I TEST, MODEL 1001
VANCOUVER BIOTECH LTD. 510(k) NO: K023505(TRADITIONAL)
ATTN: ROBIN J HELLEN, M.S. PHONE NO : 818-709-5646
9418 LASAINE AVENUE SE DECISION MADE: 31-MAR-03
NORTHRIDGE, CA 91325 510(k) STATEMENT
DEVICE: VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER ACCES
VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K030005(TRADITIONAL)
ATTN: MIKE SAMMON PHONE NO : 863-904-1628
5307 GREAT OAK DR. SE DECISION MADE: 18-MAR-03
LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K030114(TRADITIONAL)
ATTN: MIKE SIMMONS PHONE NO : 863-904-1628
5307 GREAT OAK DR. SE DECISION MADE: 21-MAR-03
LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GAMMAMED 212 AND 232 SOURCE ASSEMBLY
VARIAN MEDICAL SYSTEMS 510(k) NO: K030745(TRADITIONAL)
ATTN: VY TRAN PHONE NO : 650-424-5731
3100 HANSEN WAY SE DECISION MADE: 12-MAR-03
PALO ALTO, CA 94304-1038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CON
VASCULAR ARCHITECTS, INC. 510(k) NO: K030567(SPECIAL)
ATTN: PHYLLIS ELSON PHONE NO : 408-453-5150
1830 BERING DR. SE DECISION MADE: 24-MAR-03
SAN JOSE, CA 95112-4226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005
VERMONT MEDICAL, INC. 510(k) NO: K021537(TRADITIONAL)
ATTN: MARC FILLION PHONE NO : 802-463-9976
INDUSTRIAL PARK SE DECISION MADE: 03-MAR-03
BELLOWS FALLS, VT 05101 510(k) STATEMENT
DEVICE: VERMED A10021 "RESTING EKG TAB ELECTRODE"
VERMONT MEDICAL, INC. 510(k) NO: K030073(SPECIAL)
ATTN: MARC FILLION PHONE NO : 802-463-9976
INDUSTRIAL PARK SE DECISION MADE: 28-MAR-03
BELLOWS FALLS, VT 05101 510(k) STATEMENT
DEVICE: VIDAR BONE TRACK SYSTEM SOFTWARE
VIDAR SYSTEMS CORP. 510(k) NO: K024171(TRADITIONAL)
ATTN: F. DAVID ROTHKOPF PHONE NO : 508-231-8842
200 HOMER AVE. SE DECISION MADE: 04-MAR-03
ASHLAND, MA 01721 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOS AC/ACP
VILLA SISTEMI MEDICALI S.P.A. 510(k) NO: K030185(ABBREVIATED)
ATTN: ANDREW HRYNDZA PHONE NO : 847-288-7000
11550 WEST KING STREET SE DECISION MADE: 11-MAR-03
FRANKLIN PARK, IL 60131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VNUS CLOSURE SYSTEM
VNUS MEDICAL TECHNOLOGIES, INC. 510(k) NO: K030557(SPECIAL)
ATTN: SAM NANAVATI PHONE NO : 408-473-1100
2200 ZANKER RD., SUITE F SE DECISION MADE: 11-MAR-03
SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BPTRU VITAL SIGNS MONITOR, MODEL BPM-300, & BPTRU PORTABLE AUTOM
VSM MEDTECH LTD. 510(k) NO: K023078(TRADITIONAL)
ATTN: DARYL WISDAHL PHONE NO : 604 738 8763
675 WEST HASTINGS ST., 15TH FL SE DECISION MADE: 21-MAR-03
VANCOUVER, B.C., CANADA V6B 1N2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIATORR ENDOPROSTHESIS
W.L. GORE & ASSOCIATES,INC 510(k) NO: K024178(TRADITIONAL)
ATTN: JACQUELINE KALBACH PHONE NO : 928-864-3731
3450 WEST KILTIE LANE SE DECISION MADE: 07-MAR-03
FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEOSPORIN SCAR SOLUTION
WARNER-LAMBERT CO. 510(k) NO: K024160(TRADITIONAL)
ATTN: JOHN R JACOBS PHONE NO : 973-385-5523
201 TABOR RD SE DECISION MADE: 17-MAR-03
MORRIS PLAINS, NJ 07950 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B
WELL-LIFE HEALTHCARE, INC. 510(k) NO: K030537(TRADITIONAL)
ATTN: TONY C. S. CHANG PHONE NO : 886 422 972787
NO. 5 ALLEY 5 LANE CHENG HSING SE DECISION MADE: 20-MAR-03
CHUNG CHING RD., PEI TUN DIST. 510(k) SUMMARY AVAILABLE FROM FDA
TAICHUNG, CHINA (TAIWAN)
DEVICE: AGC CEM
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K030168(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 49 723 13705219
SCHWENNINGER STRABE 13 SE DECISION MADE: 21-MAR-03
PFORZHEIM, GERMANY D-75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTA IMPLANT
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K030312(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 49 723 13705219
SCHWENNINGER STRABE 13 SE DECISION MADE: 26-MAR-03
PFORZHEIM, GERMANY D-75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS C
WIENER LABORATORIES 510(k) NO: K030482(TRADITIONAL)
ATTN: VIVIANA CETOLA PHONE NO : 543 414 329191
2944 RIOBAMBA SE DECISION MADE: 19-MAR-03
ROSARIO, ARGENTINA 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006
WIENER LABORATORIES S.A.I.C. 510(k) NO: K024305(TRADITIONAL)
ATTN: VIVIANA CETOLA PHONE NO : 54 341 4329191
2944 RIOBAMBA SE DECISION MADE: 18-MAR-03
ROSARIO, ARGENTINA 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGHTFIX
WORLD OF MEDICINE LEMKE GMBH 510(k) NO: K024251(TRADITIONAL)
ATTN: SUSANNE RAAB PHONE NO : 617-868-3995
91 TROWBRIDGE STREET SE DECISION MADE: 18-MAR-03
CAMBRIDGE, MA 02138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIIG II BONE GRAFT SUBSTITUTE
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K024336(SPECIAL)
ATTN: EHAB M ESMAIL PHONE NO : 901-867-4732
5677 AIRLINE RD. SE DECISION MADE: 04-MAR-03
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XYLOS SURGICAL MESH
XYLOS CORPORATION 510(k) NO: K023237(TRADITIONAL)
ATTN: PATSY TRISLER PHONE NO : 202-835-1346
815 CONNECTICUT AVE., NW. SE DECISION MADE: 18-MAR-03
SUITE 800 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20006
DEVICE: XYLOS XCELL ANTIMICROBIAL DRESSING
XYLOS CORPORATION 510(k) NO: K024054(TRADITIONAL)
ATTN: PATSY TRISLER PHONE NO : 202-835-1346
815 CONNECTICUT AVE., NW. SE DECISION MADE: 07-MAR-03
SUITE 800 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20006
DEVICE: NON-STERILE, POWDER-FREE, POLYMER COATED, NATURAL AND/OR VIOLET
YTY INDUSTRY (MANJUNG) SDN. BHD. 510(k) NO: K030164(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 07-MAR-03
SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DELWA-STAR WS-FM BLOOD PRESSURE AND BODY FAT MONITOR
ZEWA, INC. 510(k) NO: K024077(TRADITIONAL)
ATTN: THOMAS ZEINDLER PHONE NO : 305-463-7551
10438 NW 31ST TERRACE SE DECISION MADE: 10-MAR-03
MIAMI, FL 33172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00
ZIMMER, INC. 510(k) NO: K030265(SPECIAL)
ATTN: DALENE T BINKLEY PHONE NO : 574-372-4907
P.O. BOX 708 SE DECISION MADE: 04-MAR-03
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 300
TOTAL WITH SUMMARIES 234
TOTAL WITH STATEMENTS 66
Updated 4/7/2003
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