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510(k)s Final Decisions Rendered for September 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-SEP-2003 THROUGH 30-SEP-2003
DEVICE: STERI-DRAPE SURGICAL DRAPES
3M COMPANY 510(k) NO: K031287(TRADITIONAL)
ATTN: SCOTT S SARDESON PHONE NO : 651-736-2025
3M CENTER, BLDG. 275-5W-06 SE DECISION MADE: 10-SEP-03
ST. PAUL, MN 55133-3275 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUDIT MICROCONTROLS MICROFD BNP CONTROL
AALTO SCIENTIFIC LTD. 510(k) NO: K032122(TRADITIONAL)
ATTN: ALAN J VEKICH PHONE NO : 760-431-7922
1959 KELLOGG AVE. SE DECISION MADE: 09-SEP-03
CARLSBAD, CA 92008 510(k) STATEMENT
DEVICE: CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY
ACCESS BIO INCORPORATE 510(k) NO: K032159(TRADITIONAL)
ATTN: YOUNG HO CHOI PHONE NO : 732-246-7400
675 US HIGHWAY 1 SE DECISION MADE: 05-SEP-03
NORTH BRUNSWICK, NJ 08902 510(k) STATEMENT
DEVICE: CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY
ACCURAY, INC. 510(k) NO: K032345(SPECIAL)
ATTN: ANNE SCHLAGENHAFT PHONE NO : 408-522-3740
570 DEL REY AVE. SE DECISION MADE: 03-SEP-03
SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACMI M4 TELESCOPES
ACMI CORPORATION 510(k) NO: K031758(TRADITIONAL)
ATTN: GABRIEL J MURACA PHONE NO : 508-804-2754
136 TURNPIKE RD. SE DECISION MADE: 02-SEP-03
SOUTHBOROUGH, MA 01772-2104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST
ACON LABORATORIES, INC. 510(k) NO: K032510(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 22-SEP-03
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUEITY MEDICAL LIGHT SOURCE
ACUEITY, INC. 510(k) NO: K032430(TRADITIONAL)
ATTN: NANCY LINCE PHONE NO : 650-759-6186
100 HAMILTON AVE., SUITE 140 SE DECISION MADE: 05-SEP-03
PALO ALTO, CA 94301 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: EXCISOR BIOPTOME, MODEL 01-0004
ACUEITY, INC. 510(k) NO: K032847(TRADITIONAL)
ATTN: NANCY LINCE PHONE NO : 650-759-6186
100 HAMILTON AVE., SUITE 140 SE DECISION MADE: 26-SEP-03
PALO ALTO, CA 94301 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BLINK CL LUBRICANT EYE DROPS
ADVANCED MEDICAL OPTICS, INC. 510(k) NO: K032030(TRADITIONAL)
ATTN: PAUL J NOWACKI PHONE NO : 714-247-8601
1700 E. ST. ANDREW PLACE SE DECISION MADE: 25-SEP-03
P.O. BOX 25162 510(k) SUMMARY AVAILABLE FROM FDA
SANTA ANA, CA 92799-5162
DEVICE: HEMAPROMPT GASTRIC
AERSCHER DIAGNOSTICS 510(k) NO: K031356(TRADITIONAL)
ATTN: ROBERT SCHREIBER PHONE NO : 410-778-2957
353 HIGH ST. SE DECISION MADE: 24-SEP-03
CHESTERTOWN, MD 21620 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMPLATZER VASCULAR PLUG
AGA MEDICAL CORP. 510(k) NO: K031810(TRADITIONAL)
ATTN: PATRICE M STROMBERG PHONE NO : 763-513-9227
682 MENDELSSOHN AVE. SE DECISION MADE: 09-SEP-03
GOLDEN VALLEY, MN 55427 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300
AGFA CORP. 510(k) NO: K032635(SPECIAL)
ATTN: JEFF JEDLICKA PHONE NO : 864-421-1815
10 SOUTH ACADEMY ST. SE DECISION MADE: 24-SEP-03
GREENVILLE, SC 29601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AKERS LABORATORIES INC. BLOOD CELL SEPARATOR
AKERS LABORATORIES, INC. 510(k) NO: K030815(TRADITIONAL)
ATTN: BARBARA A BAGBY PHONE NO : 856-848-8698
201 GROVE RD. SE DECISION MADE: 17-SEP-03
THOROFARE, NJ 08086 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PRECISE CARBON FIBER TABLE TOP, MODEL 11-999
AKTINA MEDICAL PHYSICS CORP. 510(k) NO: K032248(TRADITIONAL)
ATTN: TONY SPACCAROTELLA PHONE NO : 845-268-0101
360 NORTH ROUTE 9W SE DECISION MADE: 25-SEP-03
CONGERS, NY 10920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDLEY PCA MODULE, MODEL 8120
ALARIS MEDICAL SYSTEMS, INC. 510(k) NO: K032233(TRADITIONAL)
ATTN: STACEY L LEWIS PHONE NO : 858-458-7563
10221 WATERIDGE CIR. SE DECISION MADE: 09-SEP-03
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED ELECTROPHYSIOLOGY CATHETER
ALLIANCE MEDICAL, INC. 510(k) NO: K030187(TRADITIONAL)
ATTN: MOIRA BARTON PHONE NO : 480-763-5300
10232 SOUTH 51 ST. SE DECISION MADE: 24-SEP-03
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALOKA MODEL SSD-5500 V6.0 ULTRASOUND SYSTEM
ALOKA CO. LTD USA 510(k) NO: K032875(TRADITIONAL)
ATTN: RICHARD J CEHOVSKY PHONE NO : 203-269-5088
10 FAIRFIELD BLVD. SE DECISION MADE: 30-SEP-03
WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ALEXIS WOUND RETRACTOR
APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K031889(TRADITIONAL)
ATTN: MARY JO STEGWELL PHONE NO : 949-713-8326
22872 AVENIDA EMPRESSA SE DECISION MADE: 22-SEP-03
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VINYL EXAMINATION GLOVES, POWDER FREE AND PINK COLOR
ARISTA LATINDO INDUSTRIAL, LTD. P.510(k) NO: K031944(TRADITIONAL)
ATTN: LINGA SUMARTA PHONE NO : 622 166 20201195
JL: K.H.MOH MANSYUR NO. 128 SE DECISION MADE: 23-SEP-03
JAKARTA, INDONESIA 11210 510(k) STATEMENT
DEVICE: ARKIT HBA1C
ARKRAY, INC. 510(k) NO: K030553(TRADITIONAL)
ATTN: GARY M HAIGHT PHONE NO : 910-254-7343
2320 SCIENTIFIC PARK DR. SE DECISION MADE: 02-SEP-03
WILMINGTON, NC 28405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX TRIMIT SCREW, MODEL AR-4161B
ARTHREX, INC. 510(k) NO: K031945(TRADITIONAL)
ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553
2885 SOUTH HORSESHOE DR. SE DECISION MADE: 22-SEP-03
NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM
ARTHREX, INC. 510(k) NO: K032187(TRADITIONAL)
ATTN: SALLY FOUST PHONE NO : 239-643-5553
2885 SOUTH HORSESHOE DR. SE DECISION MADE: 22-SEP-03
NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALANTECH GRAFT FIXATION SCREW
ARTHROCARE CORP. 510(k) NO: K031937(TRADITIONAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224
680 VAQUEROS AVE. SE DECISION MADE: 04-SEP-03
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300
ASAHI INTECC CO., LTD. 510(k) NO: K032615(SPECIAL)
ATTN: YOSHI TERAI PHONE NO : 949-756-8252
1100 QUAIL ST., SUITE 207 SE DECISION MADE: 16-SEP-03
NEWPORT BEACH, CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-
ASAP ENDOSCOPIC PRODUCTS GMBH 510(k) NO: K031972(TRADITIONAL)
ATTN: MARTINA GUNDEROTH PHONE NO : 49 451 3882864
KATHARINENSTR. 5 SE DECISION MADE: 15-SEP-03
LUEBECK, GERMANY 23554 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018
ASAP ENDOSCOPIC PRODUCTS GMBH 510(k) NO: K031974(TRADITIONAL)
ATTN: MARTINA GUNDEROTH PHONE NO : 49 451 3882864
KATHARINENSTR. 5 SE DECISION MADE: 29-SEP-03
LUEBECK, GERMANY 23554 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: AURORA
AURORA IMAGING TECHNOLOGY, INC. 510(k) NO: K032678(SPECIAL)
ATTN: JAMES R VEALE PHONE NO : 719-495-3438
49 PLAIN STREET SE DECISION MADE: 24-SEP-03
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXIOM BIOLASER LLLT SERIES-1
AXIOM USA. INC 510(k) NO: K030622(TRADITIONAL)
ATTN: JAMES J GIBSON PHONE NO : 813-969-2414
3830 GUNN HWY SE DECISION MADE: 09-SEP-03
TAMPA, FL 33624 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. DENTAL IMPLANT SYSTEM
B.T.I. BIOTECHNOLOGY INSTITUTE S.L510(k) NO: K022258(TRADITIONAL)
ATTN: ALFREDOCO GOMEZ PHONE NO : 34 945 297030
PARQUE TECNOLOGICO DE ALAVA SE DECISION MADE: 11-SEP-03
LEONARDO DA VINCI, 14B 510(k) SUMMARY AVAILABLE FROM FDA
01510 MINANO (ALAVA), SPAIN
DEVICE: ENDOSCOPIC APPLICATOR
BAXTER HEALTHCARE CORP. 510(k) NO: K031882(TRADITIONAL)
ATTN: LORI DONDIEGO PHONE NO : 510-818-4644
34175 ARDENWOOD BLVD. SE DECISION MADE: 05-SEP-03
FREMONT, CA 94555 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY
BAYER DIAGNOSTICS CORP. 510(k) NO: K031857(TRADITIONAL)
ATTN: ANDRES HOLLE PHONE NO : 914-524-3494
511 BENEDICT AVE. SE DECISION MADE: 04-SEP-03
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA 60 HEMATOLOGY ANALYZER
BAYER HEALTHCARE, LLC 510(k) NO: K032524(SPECIAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE. SE DECISION MADE: 08-SEP-03
TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
BAYER HEALTHCARE, LLC 510(k) NO: K032525(SPECIAL)
ATTN: ANDRES HOLLE PHONE NO : 914-524-3494
511 BENEDICT AVE. SE DECISION MADE: 09-SEP-03
TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6
BAYLIS MEDICAL CO., INC. 510(k) NO: K031951(TRADITIONAL)
ATTN: KRIS SHAH PHONE NO : 905 602 4875
5160 EXPLORER DR. #33 SE DECISION MADE: 11-SEP-03
MISSISSAUGA, ONTARIO, CANADA L4W 4510(k) STATEMENT
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/M
BD DIAGNOSTIC SYSTEMS 510(k) NO: K032153(TRADITIONAL)
ATTN: KATHRYN BABKA POWERS PHONE NO : 410-316-4260
7 LOVETON CIRCLE SE DECISION MADE: 11-SEP-03
SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP)
BD DIAGNOSTIC SYSTEMS 510(k) NO: K032518(TRADITIONAL)
ATTN: LINDA K DILLON PHONE NO : 303-390-3240
12750 W. 42ND AVENUE SE DECISION MADE: 15-SEP-03
WHEAT RIDGE, CO 80033-2440 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COULTER LH 750 HEMATOLOGY ANALYZER
BECKMAN COULTER, INC. 510(k) NO: K032342(ABBREVIATED)
ATTN: STAN SUGRUE PHONE NO : 305-380-4552
11800 SW 147TH AVE. SE DECISION MADE: 26-SEP-03
MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD ECLIPSE BIFURCATED NEEDLE
BECTON DICKINSON & CO. 510(k) NO: K032528(SPECIAL)
ATTN: PETER ZURLO PHONE NO : 201-847-6447
1 BECTON DR. SE DECISION MADE: 09-SEP-03
FRANKLIN LAKES, NJ 07417-1885 510(k) STATEMENT
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-IMIPENEM 1-16 UG/ML GRA
BECTON, DICKINSON AND COMPANY 510(k) NO: K032275(TRADITIONAL)
ATTN: MICHELLE B BANDY PHONE NO : 410-316-4778
7 LOVETON CIR. SE DECISION MADE: 29-SEP-03
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM,-AMPICILLIN 0.5.-32 UG/
BECTON, DICKINSON AND COMPANY 510(k) NO: K032299(TRADITIONAL)
ATTN: BRADFORD SPRING PHONE NO : 410-316-4206
7 LOVETON CIR. SE DECISION MADE: 22-SEP-03
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFOXITIN-GRAM NEGATIVE
BECTON, DICKINSON AND COMPANY 510(k) NO: K032567(TRADITIONAL)
ATTN: MICHELLE B BANDY PHONE NO : 410-316-4778
7 LOVETON CIR. SE DECISION MADE: 17-SEP-03
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIROBOND C
BEGO U.S.A. 510(k) NO: K032136(TRADITIONAL)
ATTN: WILLIAM OREMUS PHONE NO : 401-334-9261
24 ALBION RD., SUITE 103 SE DECISION MADE: 04-SEP-03
LINCOLN, RI 02865 510(k) STATEMENT
DEVICE: BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000
BELMONT INSTRUMENT CORP. 510(k) NO: K032674(SPECIAL)
ATTN: URAIWAN P LABADINI PHONE NO : 978-663-0212
780 BOSTON RD. SE DECISION MADE: 16-SEP-03
BILLERICA, MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LARGE VOLUME FLUID RESERVOIR
BELMONT INSTRUMENT CORP. 510(k) NO: K032778(SPECIAL)
ATTN: URAIWAN P LABADINI PHONE NO : 978-663-0212
780 BOSTON RD. SE DECISION MADE: 22-SEP-03
BILLERICA, MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743
BIO-RAD 510(k) NO: K032611(SPECIAL)
ATTN: MARIA ZEBALLOS PHONE NO : 949-598-1367
9500 JERONIMO RD. SE DECISION MADE: 17-SEP-03
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442
BIOMERIEUX, INC. 510(k) NO: K030328(TRADITIONAL)
ATTN: SANDRA PERREAND PHONE NO : 314-731-8594
595 ANGLUM RD. SE DECISION MADE: 02-SEP-03
HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 GRAM POSITIVE MOXIFLOXACIN
BIOMERIEUX, INC. 510(k) NO: K032399(TRADITIONAL)
ATTN: NANCY WEAVER PHONE NO : 314-731-8695
595 ANGLUM DR. SE DECISION MADE: 10-SEP-03
HAZELWOOD, MO 63042-2320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRA-DRIVE 3
BIOMET, INC. 510(k) NO: K031280(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 22-SEP-03
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: ACUMEN SURGICAL NAVIGATION SYSTEM
BIOMET, INC. 510(k) NO: K031337(TRADITIONAL)
ATTN: KRISTINE C ARNOLD PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 15-SEP-03
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: INTERLOK BIO-MODULAR HUMERAL STEMS
BIOMET, INC. 510(k) NO: K032507(SPECIAL)
ATTN: PATRICIA S BERES PHONE NO : 574-267-6639
56 BELL DR. SE DECISION MADE: 05-SEP-03
PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: PANTOS, MODELS: PANTOS 16, AND PANTOS DG
BLUE X IMAGING SRL 510(k) NO: K031801(TRADITIONAL)
ATTN: AL SOSA PHONE NO : 847-459-3889
251 E. DUNDEE RD. SE DECISION MADE: 11-SEP-03
SUITE #6 510(k) SUMMARY AVAILABLE FROM FDA
WHEELING, IL 60090
DEVICE: CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER
BOSTON SCIENTIFIC CORP. 510(k) NO: K030966(TRADITIONAL)
ATTN: JODI LYNN GREENIZEN PHONE NO : 518-742-4338
10 GLENS FALLS TECHNICAL PARK SE DECISION MADE: 23-SEP-03
DIX AVENUE 510(k) SUMMARY AVAILABLE FROM FDA
GLENS FALLS, NY 12801-3864
DEVICE: SENTINOL NITINOL BILLARY STENT SYSTEM
BOSTON SCIENTIFIC CORP. 510(k) NO: K032025(TRADITIONAL)
ATTN: TODD KOMMANN PHONE NO : 763-494-2467
ONE SCIMED PLACE SE DECISION MADE: 25-SEP-03
MAPLE GROVE, MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CONTOUR SE MICROSPHERES
BOSTON SCIENTIFIC CORP. 510(k) NO: K032542(SPECIAL)
ATTN: JODI LYNN GREENIZEN PHONE NO : 518-742-4338
10 GLENS FALLS TECHNICAL PARK SE DECISION MADE: 16-SEP-03
DIX AVENUE 510(k) SUMMARY AVAILABLE FROM FDA
GLENS FALLS, NY 12885-3864
DEVICE: VAXCEL PORT, MODEL 45-333 AND VAXCEL W/PASV PORT, MODEL 45-233
BOSTON SCIENTIFIC CORP. 510(k) NO: K032600(SPECIAL)
ATTN: JODI LYNN GREENIZEN PHONE NO : 518-742-4338
10 GLENS FALLS TECHNICAL PARK SE DECISION MADE: 09-SEP-03
GLENS FALLS, NY 12801-3864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTOUR SE MICROSPHERES (SYRINGE)
BOSTON SCIENTIFIC CORP. 510(k) NO: K032707(SPECIAL)
ATTN: JODI LYNN GREENIZEN PHONE NO : 518-742-4338
10 GLENS FALLS TECHNOLOGY PK SE DECISION MADE: 23-SEP-03
GLENS FALLS, NY 12801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANDELA SMOOTHBEAM LASER SYSTEM
CANDELA CORP. 510(k) NO: K030846(TRADITIONAL)
ATTN: LORRAINE CALZETTA PATROVIC PHONE NO : 508-358-7637
530 BOSTON POST RD. SE DECISION MADE: 16-SEP-03
WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TULIP COLORSWITCH
CAVEX HOLLAND B.V. 510(k) NO: K032116(TRADITIONAL)
ATTN: RICHARD WOORTMAN PHONE NO : 312 353 07700
PO BOX 852 SE DECISION MADE: 30-SEP-03
HAARLEM, NETHERLANDS 2003 RW 510(k) STATEMENT
DEVICE: CELON ENT SYSTEM
CELON AG MEDICAL INSTRUMENTS 510(k) NO: K032838(TRADITIONAL)
ATTN: ANDRE ROGGAN PHONE NO : 49 332 835190
8 RHEINSTRASSE SE DECISION MADE: 26-SEP-03
TELTOW, GERMANY 14513 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: WAGNER CONE PROSTHESIS
CENTERPULSE ORTHOPEDICS, INC. 510(k) NO: K032380(TRADITIONAL)
ATTN: ROBERT M WOLFARTH PHONE NO : 512-432-9324
9900 SPECTRUM DR. SE DECISION MADE: 22-SEP-03
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENOVA(R) BLOOD GLUCOSE MONITOR
CHDIAGNOSTICS LLC 510(k) NO: K032076(TRADITIONAL)
ATTN: RICHARD N PHILLIPS PHONE NO : 301-272-3115
1801 ROCKVILLE PIKE SE DECISION MADE: 30-SEP-03
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852
DEVICE: CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)
CHOLESTECH CORP. 510(k) NO: K032027(TRADITIONAL)
ATTN: THOMAS E WORTHY PHONE NO : 510-732-7200
3347 INVESTMENT BLVD. SE DECISION MADE: 05-SEP-03
HAYWARD, CA 94545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
CIBA VISION CORP. 510(k) NO: K030522(TRADITIONAL)
ATTN: STEVEN DOWDLEY PHONE NO : 678-415-3897
11460 JOHNS CREEK PKWY. SE DECISION MADE: 12-SEP-03
DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FETAL SPIRAL ELECTRODE, MODEL FSE07000
CLINICAL INNOVATIONS, INC. 510(k) NO: K030691(TRADITIONAL)
ATTN: WILLIAM DEAN WALLACE PHONE NO : 801-268-8200
747 WEST 4170 SOUTH SE DECISION MADE: 17-SEP-03
MURRAY, UT 84123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RODEO MODEL, RD12, RD14, RD16, RADIO TRANSIT MODEL, RD12T, RD14T
CONVAID PRODUCTS, INC. 510(k) NO: K032402(TRADITIONAL)
ATTN: DONALD GRIGGS PHONE NO : 310-618-0111
2830 CALIFORNIA ST. SE DECISION MADE: 24-SEP-03
TORRANCE, CA 90503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DURASIS DURAL SUBSTITUTE
COOK BIOTECH, INC. 510(k) NO: K031850(TRADITIONAL)
ATTN: MARK BLEYER PHONE NO : 765-497-3355
3055 KENT AVE. SE DECISION MADE: 08-SEP-03
WEST LAFAYETTE, IN 47906-1076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
CORDIS CORP. 510(k) NO: K032137(SPECIAL)
ATTN: SAM MIRZA PHONE NO : 786-313-2007
14201 N.W. 60TH AVE. SE DECISION MADE: 17-SEP-03
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY
CORDIS CORP. 510(k) NO: K032457(SPECIAL)
ATTN: SAM MIRZA PHONE NO : 786-313-2007
14201 N.W. 60TH AVE. SE DECISION MADE: 04-SEP-03
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO
CORDIS NEUROVASCULAR, INC. 510(k) NO: K032553(SPECIAL)
ATTN: AMARILYS MACHADO PHONE NO : 786-313-6493
14000 N.W. 57TH CT. SE DECISION MADE: 23-SEP-03
MIAMI LAKES, FL 33014 510(k) STATEMENT
DEVICE: PRIMOSPLINT SYSTEM
COSMEDENT, INC. 510(k) NO: K030832(TRADITIONAL)
ATTN: MICHAEL O'MALLEY PHONE NO : 312-644-9566
401 NORTH MICHIGAN AVE. SE DECISION MADE: 17-SEP-03
SUITE 2500 510(k) STATEMENT
CHICAGO, IL 60611
DEVICE: CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF R
CYBERORTHOLOGY, INC. 510(k) NO: K032169(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO : 813-645-2855
962 ALLEGRO LANE SE DECISION MADE: 22-SEP-03
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520
DADE BEHRING, INC. 510(k) NO: K031377(TRADITIONAL)
ATTN: RADAMES RIESGO PHONE NO : 305-480-7558
500 GBC DR. SE DECISION MADE: 08-SEP-03
NEWARK, DE 19702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N/T PROTEIN CONTROL
DADE BEHRING, INC. 510(k) NO: K032237(TRADITIONAL)
ATTN: KATHLEEN A DRAY-LYONS PHONE NO : 781-826-4551
GLASGOW SITE SE DECISION MADE: 05-SEP-03
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714
DEVICE: SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX
DATASCOPE CORP. 510(k) NO: K031849(ABBREVIATED)
ATTN: SUSAN E MANDY PHONE NO : 201-995-8025
800 MACARTHUR BLVD. SE DECISION MADE: 09-SEP-03
MAHWAH, NJ 07430-0619 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105
DENTSPLY GENDEX 510(k) NO: K032355(TRADITIONAL)
ATTN: JOHN R MILLER PHONE NO : 847-640-4924
901 WEST OAKTON ST. SE DECISION MADE: 25-SEP-03
DES PLAINES, IL 60018-1884 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINERVA 58 ALLOY
DENTSPLY INTERNATIONAL 510(k) NO: K032318(TRADITIONAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE. SE DECISION MADE: 30-SEP-03
P.O. BOX 872 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17405-0872
DEVICE: CERA R PLUS ALLOY
DENTSPLY INTERNATIONAL 510(k) NO: K032319(TRADITIONAL)
ATTN: P. JFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE. SE DECISION MADE: 30-SEP-03
P.O. BOX 872 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17405-0872
DEVICE: CERA F ALLOY
DENTSPLY INTERNATIONAL 510(k) NO: K032321(TRADITIONAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE. SE DECISION MADE: 30-SEP-03
P.O. BOX 872 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17405-0872
DEVICE: ULTRACROWN 75 ALLOY
DENTSPLY INTERNATIONAL 510(k) NO: K032851(SPECIAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE. SE DECISION MADE: 26-SEP-03
YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLUORIDE VARNISH
DENTSPLY INTL. 510(k) NO: K031932(TRADITIONAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE. SE DECISION MADE: 15-SEP-03
P.O. BOX 872 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17405
DEVICE: ORION E ALLOY
DENTSPLY INTL. 510(k) NO: K032316(TRADITIONAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE. SE DECISION MADE: 30-SEP-03
P.O. BOX 872 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17405
DEVICE: ORION GX ALLOY
DENTSPLY INTL. 510(k) NO: K032317(TRADITIONAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVENUE SE DECISION MADE: 30-SEP-03
P.O. BOX 872 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17405-0872
DEVICE: MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEM
DENTSPLY INTL. 510(k) NO: K032892(SPECIAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVENUE SE DECISION MADE: 26-SEP-03
YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY 1 GENTAMICIN BONE CEMENT
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K023103(TRADITIONAL)
ATTN: JANET G JOHNSON PHONE NO : 574-371-4907
700 ORTHOPAEDIC DR. SE DECISION MADE: 29-SEP-03
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: GLOBAL CAP RESURFACING REPLACEMENT SHOULDER
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K031971(TRADITIONAL)
ATTN: TIFFANI ROGERS PHONE NO : 574-371-4927
700 ORTHOPAEDIC DR. SE DECISION MADE: 24-SEP-03
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS
DEPUY, INC. 510(k) NO: K032151(SPECIAL)
ATTN: CHERYL HASTINGS PHONE NO : 574-372-7006
P.O. BOX 988 SE DECISION MADE: 26-SEP-03
700 ORTHOPAEDIC DRIVE 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: HOMOCYSTEINE MICROTITER PLATE ASSAY
DIAZYME LABORATORIES 510(k) NO: K032012(TRADITIONAL)
ATTN: GREG HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 03-SEP-03
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM)
DISCO-O-TECH MEDICAL TECHNOLOGIES,510(k) NO: K032588(SPECIAL)
ATTN: YAEL RUBIN PHONE NO : 972 995 11511
3 HASADNOAT ST. SE DECISION MADE: 12-SEP-03
HERZLIA, ISRAEL 46728 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER
DOLPHIN MEDICAL INC. 510(k) NO: K030629(TRADITIONAL)
ATTN: BILL CURNAN PHONE NO : 720-348-0389
9433 S. MORNING GLORY LN. SE DECISION MADE: 04-SEP-03
HIGHLANDS RANCH, CO 80130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLU-U, MODEL 4170
DUSA PHARMACEUTICALS, INC. 510(k) NO: K031805(TRADITIONAL)
ATTN: SCOTT LUNDAHL PHONE NO : 978-657-7500
25 UPTON DR. SE DECISION MADE: 09-SEP-03
WILMINGTON, MA 01887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI XFIX DFS SYSTEM
EBI, L.P. 510(k) NO: K031919(TRADITIONAL)
ATTN: PETER ALLAN PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 04-SEP-03
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EDWARDS DIRECTIONAL CATHETER
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K030630(TRADITIONAL)
ATTN: KEVIN DRISKO PHONE NO : 949-250-2416
ONE EDWARDS WAY SE DECISION MADE: 03-SEP-03
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM
EKF DIAGNOSTIC GMBH 510(k) NO: K031898(TRADITIONAL)
ATTN: STEPHEN GORSKI PHONE NO : 262-594-2114
S65 W35739 PIPER ROAD SE DECISION MADE: 24-SEP-03
EAGLE, WI 53119 510(k) STATEMENT
DEVICE: ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR
ELAN DIAGNOSTICS 510(k) NO: K030003(TRADITIONAL)
ATTN: WYNN STOCKING PHONE NO : 714-672-3553
1075 W. LAMBERT RD., SUITE D SE DECISION MADE: 29-SEP-03
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATAC TOTAL BILIRUBIN REAGENT
ELAN DIAGNOSTICS 510(k) NO: K030014(TRADITIONAL)
ATTN: WYNN STOCKING PHONE NO : 714-672-3553
1075 W. LAMBERT RD., SUITE D SE DECISION MADE: 26-SEP-03
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)
ELCAM MEDICAL ACAL 510(k) NO: K032393(TRADITIONAL)
ATTN: BRUCE WARD PHONE NO : 602-216-6940
7600 NORTH 15TH STREET SE DECISION MADE: 12-SEP-03
SUITE 217 510(k) SUMMARY AVAILABLE FROM FDA
PHOENIX, AZ 85020
DEVICE: HANDYDOP
ELCAT, GMBH 510(k) NO: K030466(ABBREVIATED)
ATTN: JAY MANSOUR PHONE NO : 770-777-4146
1308 MORNINGSIDE PARK DR. SE DECISION MADE: 12-SEP-03
ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYCLONE ANTERIOR CERVICAL PLATE SYSTEM
ENCORE MEDICAL, L.P. 510(k) NO: K031214(TRADITIONAL)
ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-832-9500
9800 METRIC BLVD. SE DECISION MADE: 23-SEP-03
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESKA MODULAR HIP SYSTEM CEMENTED
ESKA IMPLANTS GMBH 510(k) NO: K030867(TRADITIONAL)
ATTN: THOMAS P MONKUS PHONE NO : 941-744-5400
101 RIVERFRONT BLVD. SE DECISION MADE: 22-SEP-03
SUITE 600 510(k) SUMMARY AVAILABLE FROM FDA
BRADENTON, FL 34205
DEVICE: PROCEED TRILAMINATE SURGICAL MESH
ETHICON, INC. 510(k) NO: K031925(TRADITIONAL)
ATTN: REY LIBROJO PHONE NO : 908-218-3198
ROUTE 22 WEST SE DECISION MADE: 17-SEP-03
SOMERVILLE, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6
EXACTECH, INC. 510(k) NO: K032606(SPECIAL)
ATTN: MARTIN SPRUNCK PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 23-SEP-03
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EYESOPEN TONOMETER
EYE-DEAS, LLC 510(k) NO: K032769(TRADITIONAL)
ATTN: STEVEN E FELDON PHONE NO : 585-381-8081
39 SANDRINGHAM RD. SE DECISION MADE: 23-SEP-03
ROCHESTER, NY 14610 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BECKER TRANSNASAL LACRIMAL (INTUBATION SETS)
FCI OPHTHALMICS, INC. 510(k) NO: K023758(TRADITIONAL)
ATTN: HILLARD W WELCH PHONE NO : 508-775-5567
344 ANNABELLE POINT RD. SE DECISION MADE: 17-SEP-03
CENTERVILLE, MA 02632-2402 510(k) STATEMENT
DEVICE: PHEM-ALERT
FEMTEK,LLC. 510(k) NO: K032161(TRADITIONAL)
ATTN: JOEL S FADEN PHONE NO : 301-881-9139
11605 HITCHING POST LN. SE DECISION MADE: 30-SEP-03
ROCKVILLE, MD 20852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS
FIRST QUALITY HYGIENIC, INC. 510(k) NO: K032173(TRADITIONAL)
ATTN: ROBERT J STAAB PHONE NO : 201-327-0035
73 FRANKLIN TURNPIKE SE DECISION MADE: 03-SEP-03
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GALIX WINTER
GALIX BIOMEDICAL INSTRUMENTATION, 510(k) NO: K030145(TRADITIONAL)
ATTN: EDUARDO REY PHONE NO : 305-534-5905
2555 COLLINS AVE., C-5 SE DECISION MADE: 17-SEP-03
MIAMI BEACH, FL 33140 510(k) STATEMENT
DEVICE: PRISMA M60/M100 SETS
GAMBRO, INC. 510(k) NO: K032431(SPECIAL)
ATTN: ROD J RYLANDS PHONE NO : 303-542-5075
10810 W. COLLINS AVE. SE DECISION MADE: 15-SEP-03
LAKEWOOD, CO 80215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNITY NETWORK PATIENT DATA SERVER
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K032582(TRADITIONAL)
ATTN: KAREN LUNDE PHONE NO : 414-362-3329
8200 WEST TOWER AVE. SE DECISION MADE: 17-SEP-03
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004
GFE MEDIZINTECHNIK GMBH 510(k) NO: K031225(TRADITIONAL)
ATTN: JOHN E SAWYER PHONE NO : 801-685-7050
6254 SOUTH 1280 EAST SE DECISION MADE: 29-SEP-03
SALT LAKE CITY, UT 84121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GI SUPPLY BILIARY STENT
GI SUPPLY 510(k) NO: K031360(TRADITIONAL)
ATTN: ROB WHALEN PHONE NO : 860-684-0030
25 VILLAGE HILL ROAD SE DECISION MADE: 24-SEP-03
WILLINGTON, CT 06279 510(k) STATEMENT
DEVICE: OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER
HAAG-STREIT HOLDING AG 510(k) NO: K030393(TRADITIONAL)
ATTN: EDUARDO MARCH PHONE NO : 301-838-3120
7361 CALHOUN PLACE, SUITE 500 SE DECISION MADE: 25-SEP-03
ROCKVILLE, MD 20855-2465 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARABELLA NCPAP MASKS
HAMILTON MEDICAL AG 510(k) NO: K030563(TRADITIONAL)
ATTN: J. DAVID THOMPSON PHONE NO : 775-858-3200
PO BOX 30008 SE DECISION MADE: 09-SEP-03
RENO, NV 89502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIT & FISSURE SEALANT WITH FLUORIDE
HARRY J. BOSWORTH CO. 510(k) NO: K031811(TRADITIONAL)
ATTN: MILDRED M GOLDSTEIN PHONE NO : 847-679-3400
7227 NORTH HAMLIN AVE. SE DECISION MADE: 04-SEP-03
SKOKIE, IL 60076 510(k) STATEMENT
DEVICE: PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05,
HDC CORP. 510(k) NO: K022752(TRADITIONAL)
ATTN: EARL SMART PHONE NO : 408-942-7340
628 GIBRALTAR COURT SE DECISION MADE: 09-SEP-03
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SELDINGER SAFETY NEEDLE INTRODUCER
HDC CORP. 510(k) NO: K032404(SPECIAL)
ATTN: EARL SMART PHONE NO : 408-942-7340
628 GIBRALTAR CT. SE DECISION MADE: 10-SEP-03
MILPITAS, CA 95035 510(k) STATEMENT
DEVICE: MAKY 21.1 DIALYZER REPROCESSING SYSTEM
HDC MAQUINOLAS, LLC 510(k) NO: K024076(TRADITIONAL)
ATTN: LORI K HOLDER PHONE NO : 713-398-4546
8508 BEACON BEND LN. SE DECISION MADE: 26-SEP-03
PEARLAND, TX 77584 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALACOS R
HERAEUS KULZER GMBH & CO. KG 510(k) NO: K030902(ABBREVIATED)
ATTN: K.D. KUHN PHONE NO : 496 081 959264
GRUNER WEG 11 SE DECISION MADE: 23-SEP-03
HANAU, GERMANY D-63450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOPAL
HERAEUS KULZER GMBH & CO. KG 510(k) NO: K030903(ABBREVIATED)
ATTN: K.D. KUHN PHONE NO : 496 081 959264
GRUNER WEG 11 SE DECISION MADE: 23-SEP-03
HANAU, GERMANY D-63450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALAMED
HERAEUS KULZER GMBH & CO. KG 510(k) NO: K030904(ABBREVIATED)
ATTN: K.D. KUHN PHONE NO : 496 081 959264
GRUNER WEG 11 SE DECISION MADE: 23-SEP-03
HANAU, GERMANY D-63450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO HIGHGATE CURVED ROD SYSTEM
HIGHGATE ORTHOPAEDICS 510(k) NO: K023983(SPECIAL)
ATTN: KAREN E WARDEN PHONE NO : 440-740-0879
7000 MILL RD. SE DECISION MADE: 22-SEP-03
CLEVELAND, OH 44141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K032232(ABBREVIATED)
ATTN: DOUGLAS THISTLETHWAITE PHONE NO : 330-425-1313
1959 SUMMIT COMMERCE PARK SE DECISION MADE: 29-SEP-03
TWINSBURG, OH 44087-2371 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIUMPH VTX WITH LIFEVALVE CATHETER
HORIZON MEDICAL PRODUCTS, INC. 510(k) NO: K032557(SPECIAL)
ATTN: SCOTT MOELLER PHONE NO : 800-472-5221
1 HORIZON WAY SE DECISION MADE: 09-SEP-03
MANCHESTER, GA 31816 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VORTEX MP
HORIZON MEDICAL PRODUCTS, INC. 510(k) NO: K032754(SPECIAL)
ATTN: SCOTT MOELLER PHONE NO : 800-472-5221
1 HORIZON WAY SE DECISION MADE: 12-SEP-03
MANCHESTER, GA 31816 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K031729(TRADITIONAL)
ATTN: MARGARET F CROWE PHONE NO : 201-831-5580
59 ROUTE 17 SE DECISION MADE: 02-SEP-03
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DURACON TOTAL KNEE SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K032163(TRADITIONAL)
ATTN: DENISE DUCHENE PHONE NO : 201-831-5612
59 ROUTE 17 SOUTH SE DECISION MADE: 12-SEP-03
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING
HOWMEDICA OSTEONICS CORP. 510(k) NO: K032418(TRADITIONAL)
ATTN: DENISE DUCHENE PHONE NO : 201-831-5612
59 ROUTE 17 SE DECISION MADE: 11-SEP-03
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOWMEDICA OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS
HOWMEDICA OSTEONICS CORP. 510(k) NO: K032479(SPECIAL)
ATTN: MARGARET F CROWE PHONE NO : 201-831-5580
59 ROUTE 17 SE DECISION MADE: 04-SEP-03
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE
HYDROCISION, INC. 510(k) NO: K032529(SPECIAL)
ATTN: DEBBIE IAMPIETRO PHONE NO : 508-259-7374
7 TIFFANY SE DECISION MADE: 16-SEP-03
HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I-STAT KAOLIN ACT TEST
I-STAT CORPORATION 510(k) NO: K023582(TRADITIONAL)
ATTN: PAUL VANDERWERF PHONE NO : 609-443-9300
104 WINDSOR CENTER DR. SE DECISION MADE: 08-SEP-03
EAST WINDSOR, NJ 08520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I-STAT CARDIAC TROPONIN (CTNI) TEST
I-STAT CORPORATION 510(k) NO: K031739(TRADITIONAL)
ATTN: GREGORY W SHIPP PHONE NO : 609-443-9300
104 WINDSOR CENTER DR. SE DECISION MADE: 02-SEP-03
EAST WINDSOR, NJ 08520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONDUCTIVITY STANDARD SOLUTION-METERCARE
IBP INSTRUMENTS GMBH 510(k) NO: K032075(TRADITIONAL)
ATTN: WERNER PFINGSTMANN PHONE NO : 49 511 651647
SUTELSTRASSE 7A SE DECISION MADE: 17-SEP-03
HANNOVER, GERMANY D30659 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060
IDEV TECHNOLOGIES, INC. 510(k) NO: K030504(TRADITIONAL)
ATTN: LYNNE A DAVIES PHONE NO : 281-333-1998
1110 NASA RD., SUITE 311 SE DECISION MADE: 16-SEP-03
HOUSTON, TX 77058-3345 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 51CM(20.1INCH) TFT MONOCHROME LCD MONITOR, MU5111BW
IIYAMA CORPORATION 510(k) NO: K032020(TRADITIONAL)
ATTN: KAZUYOSHI TATEIWA PHONE NO : 812 626 35114
710-1 KITAOWARIBE SE DECISION MADE: 02-SEP-03
NAGANO CITY, NAGANO, JAPAN 381-001510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR
IMAGYN MEDICAL TECHNOLOGIES, INC. 510(k) NO: K032491(SPECIAL)
ATTN: JULIE POWELL PHONE NO : 269-623-6836
1 PARK PLAZA, SUITE 1100 SE DECISION MADE: 04-SEP-03
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER
IMC-HEARTWAY, LLC 510(k) NO: K031897(ABBREVIATED)
ATTN: JUAN CARLOS RIVERA PHONE NO : 239-275-6767
6140 MID METRO DRIVE, SUITE 6 SE DECISION MADE: 23-SEP-03
FORT MYERS, FL 33912 510(k) STATEMENT
DEVICE: IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA
IMMCO DIAGNOSTICS, INC. 510(k) NO: K030701(TRADITIONAL)
ATTN: KEVIN J LAWSON PHONE NO : 716-691-0091
60 PINEVIEW DR. SE DECISION MADE: 09-SEP-03
BUFFALO, NY 14228 510(k) STATEMENT
DEVICE: IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA
IMMCO DIAGNOSTICS, INC. 510(k) NO: K030702(TRADITIONAL)
ATTN: KEVIN J LAWSON PHONE NO : 716-691-0091
60 PINEVIEW DR. SE DECISION MADE: 09-SEP-03
BUFFALO, NY 14228 510(k) STATEMENT
DEVICE: 3I DENTAL IMPLANTS
IMPLANT INNOVATIONS, INC. 510(k) NO: K030614(TRADITIONAL)
ATTN: JACQUELYN A HUGHES PHONE NO : 561-776-6819
4555 RIVERSIDE DR. SE DECISION MADE: 15-SEP-03
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSSEOTITE IOL IMPLANTS AND OSSEOTITE CERTAIN IOL IMPLANTS
IMPLANT INNOVATIONS, INC. 510(k) NO: K031632(TRADITIONAL)
ATTN: JACQUELYN A HUGHES, RAC PHONE NO : 561-776-6819
4555 RIVERSIDE DR. SE DECISION MADE: 16-SEP-03
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW T
IMPLEX CORP. 510(k) NO: K031449(TRADITIONAL)
ATTN: ROBERT A POGGIE PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 23-SEP-03
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INOVO, INC, ECONOMIZER CONSERVING REGULATOR
INOVO, INC. 510(k) NO: K031983(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD SE DECISION MADE: 15-SEP-03
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: DURAGEN PLUS DURAL GRAFT MATRIX
INTEGRA LIFESCIENCES CORP. 510(k) NO: K032693(SPECIAL)
ATTN: DIANA M BORDON PHONE NO : 609-275-0500
311 ENTERPRISE DR. SE DECISION MADE: 30-SEP-03
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TI FENESTRATED PLATE
INTERPORE CROSS INTL. 510(k) NO: K031772(ABBREVIATED)
ATTN: WENDY SPIELBERGER PHONE NO : 949-453-3200
181 TECHNOLOGY DR. SE DECISION MADE: 05-SEP-03
IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRALASE FS2 LASER
INTRALASE CORP. 510(k) NO: K031960(TRADITIONAL)
ATTN: JUDY F GORDON PHONE NO : 949-854-6314
2 DELPHINUS SE DECISION MADE: 29-SEP-03
IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INVIRO SNAP SAFETY SYRINGE, 1CC, 3CC, 5CC, AND 10CC
INVIRO MEDICAL 510(k) NO: K032780(SPECIAL)
ATTN: JIM BARLEY PHONE NO : 949-364-9349
28481 LA FALDA SE DECISION MADE: 24-SEP-03
LAGUNA NIGUEL, CA 92677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALEXANDER
IVOCLAR VIVADENT, INC. 510(k) NO: K032493(TRADITIONAL)
ATTN: ANDERJEET S GULATI PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 04-SEP-03
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: DW 296 #15 SOLDER
IVOCLAR VIVADENT, INC. 510(k) NO: K032715(TRADITIONAL)
ATTN: ANDERJEET GULATI PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 26-SEP-03
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: R&D; DESIGNATION AP-052-5
JENSEN INDUSTRIES, INC. 510(k) NO: K032267(TRADITIONAL)
ATTN: JOHN SLANSKI PHONE NO : 203-239-2090
50 STILLMAN RD. SE DECISION MADE: 17-SEP-03
NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JUSTWIN SCOOTER, MODEL JS-401
JOY RIDE TECH CO., LTD. 510(k) NO: K032277(TRADITIONAL)
ATTN: SHU CHEN CHANG PHONE NO : 614-451-1918
2064 TAMARIN DR. SE DECISION MADE: 24-SEP-03
COLUMBUS, OH 43235 510(k) STATEMENT
DEVICE: BLOOD PRESSURE MONITOR, MODEL KP-7000
K-JUMP HEALTH CO., LTD. 510(k) NO: K032492(SPECIAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEEN STREET, N.W. SE DECISION MADE: 09-SEP-03
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KSEA MEDI PACK
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K022490(TRADITIONAL)
ATTN: JAMES A LEE PHONE NO : 310-410-2769
600 CORPORATE POINTE 5TH FLOOR SE DECISION MADE: 29-SEP-03
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KSEA OPSERVER LAP
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K031895(TRADITIONAL)
ATTN: JAMES A LEE PHONE NO : 310-410-2782
600 CORPORATE POINTE SE DECISION MADE: 23-SEP-03
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RINSPIRATION SYSTEM
KERBEROS PROXIMAL SOLUTIONS 510(k) NO: K031485(TRADITIONAL)
ATTN: TOM MASON PHONE NO : 650-254-1005
1400 TERRA BELLA, SUITE K SE DECISION MADE: 25-SEP-03
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KONICA LASER IMAGER, MODEL DRYPRO MODEL 771
KONICA MEDICAL AND GRAPHIC CORPORA510(k) NO: K032681(SPECIAL)
ATTN: SHINICHI YAMANAKA PHONE NO : 815 963 70190
319 AKENO, OBATA-CHO SE DECISION MADE: 24-SEP-03
WATARAI-GUN 510(k) STATEMENT
MIE-KEN, JAPAN
DEVICE: TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT
KRONUS MARKET DEVELOPMENT ASSOCIAT510(k) NO: K032134(TRADITIONAL)
ATTN: HEATHER VIELE PHONE NO : 208-377-4800
12554 WEST BRIDGER ST. SE DECISION MADE: 10-SEP-03
SUITE 108 510(k) STATEMENT
BOISE, ID 83713
DEVICE: KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A
KYPHON, INC. 510(k) NO: K032212(TRADITIONAL)
ATTN: TIM REEVES PHONE NO : 408-548-6500
1350 BORDEAUX DR. SE DECISION MADE: 15-SEP-03
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE LIFECORE STAGE-1 ANGLED ABUTMENT SYSTEM
LIFECORE BIOMEDICAL, INC. 510(k) NO: K032495(TRADITIONAL)
ATTN: DIANE BRINZA PHONE NO : 952-368-6394
3515 LYMAN BLVD. SE DECISION MADE: 17-SEP-03
CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BENZODIAZEPINE ENZYME IMMUNOASSAY
LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K032365(TRADITIONAL)
ATTN: CHENG-I LIN PHONE NO : 408-732-3856
687 NORTH PASTORIA AVE. SE DECISION MADE: 05-SEP-03
SUNNYVALE, CA 94085-2917 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MACROPORE CARDIO-WRAP (TS)
MACROPORE BIOSURGERY, INC. 510(k) NO: K031785(TRADITIONAL)
ATTN: KENNETH K KLEINHENZ PHONE NO : 858-458-0900
6740 TOP GUN ST. SE DECISION MADE: 04-SEP-03
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET
MACROPORE BIOSURGERY, INC. 510(k) NO: K031955(TRADITIONAL)
ATTN: KENNETH K KLEINHENZ PHONE NO : 858-458-0900
6740 TOP GUN ST. SE DECISION MADE: 22-SEP-03
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MARQUETTE HUBER TRAP SAFETY INFUSION SET
MARQUETTE MEDICAL, INC. 510(k) NO: K021471(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 888-729-9674
P.O. BOX 4341 SE DECISION MADE: 08-SEP-03
CROFTON, MD 20850 510(k) STATEMENT
DEVICE: MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES
MATANG MFG. SDN. BHD. 510(k) NO: K032549(TRADITIONAL)
ATTN: KOK-KEE HON PHONE NO : 703-941-7656
6324 MEETING HOUSE WAY SE DECISION MADE: 08-SEP-03
ALEXANDRIA, VA 22312-1718 510(k) STATEMENT
DEVICE: BEELINE SYSTEM
MCKINLEY, INC. 510(k) NO: K032642(SPECIAL)
ATTN: ANDY LAMBORNE PHONE NO : 303-420-9569
4080 YOUNGFIELD ST. SE DECISION MADE: 23-SEP-03
WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAYCELL
MDS NORDION 510(k) NO: K032684(SPECIAL)
ATTN: A. WARBICK-CERONE PHONE NO : 613 592 3400
447 MARCH RD. SE DECISION MADE: 26-SEP-03
OTTAWA, ONTARIO, CANADA K2K1X8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXOMIO, MODEL 2.0 SP1
MEDCOM GMBH 510(k) NO: K032550(SPECIAL)
ATTN: STEFAN WALTER PHONE NO : 496 151 9514717
RUNDETURMSTR. 12 SE DECISION MADE: 25-SEP-03
DARMSTADT, HESSEN, GERMANY 64283 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEX-NECK PD CATHETER, INFANT
MEDIGROUP, INC. 510(k) NO: K031351(TRADITIONAL)
ATTN: JOHN A NAVIS PHONE NO : 630-428-4143
505 WESTON RIDGE DR. SE DECISION MADE: 17-SEP-03
NAPERVILLE, IL 60563-3932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDLINE REUSABLE SURGICAL GOWNS (100X)
MEDLINE INDUSTRIES, INC. 510(k) NO: K031933(TRADITIONAL)
ATTN: STACEY BOLEN-WOLVERTON PHONE NO : 847-949-2639
ONE MEDLINE PL. SE DECISION MADE: 16-SEP-03
MUNDELEIN, IL 60060-4486 510(k) STATEMENT
DEVICE: MEDLINE BAND BAGS AND EQUIPMENT COVERS
MEDLINE INDUSTRIES, INC. 510(k) NO: K032065(TRADITIONAL)
ATTN: LARA N SIMMONS PHONE NO : 847-578-6072
1170 S. NORTHPOINT BLVD. SE DECISION MADE: 22-SEP-03
WAUKEGAN, IL 60085 510(k) STATEMENT
DEVICE: MEDRAD CONTINUUM MR INFUSION SYSTEM
MEDRAD, INC. 510(k) NO: K032771(SPECIAL)
ATTN: ANDREW P ZELTWANGER PHONE NO : 412-767-2400
ONE MEDRAD DR. SE DECISION MADE: 23-SEP-03
INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC AVE BRIDGE CONSTANT BILIARY STENT SYSTEM OR ('CONSTANT
MEDTRONIC AVE, INC. 510(k) NO: K030633(TRADITIONAL)
ATTN: SARAH SHEPPARD PHONE NO : 707-591-2234
3576 UNOCAL PL. SE DECISION MADE: 02-SEP-03
SANTA ROSA, CA 95403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K031833(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 03-SEP-03
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K032033(TRADITIONAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 12-SEP-03
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE)
MEDTRONIC SOFAMOR DANEK 510(k) NO: K032037(TRADITIONAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 04-SEP-03
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TSRH SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K031967(TRADITIONAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 17-SEP-03
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TSRH SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K032578(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 17-SEP-03
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHE
MEDTRONIC, INC. 510(k) NO: K032561(SPECIAL)
ATTN: LUCY TAN PHONE NO : 763-505-1465
710 MEDTRONIC PARKWAY SE DECISION MADE: 11-SEP-03
MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS
MEDTRONIC, INC. 510(k) NO: K032622(SPECIAL)
ATTN: LYNN JENSEN PHONE NO : 763-514-4459
7000 CENTRAL AVENUE N. SE DECISION MADE: 03-SEP-03
FRIDLEY, MN 55432-3576 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERIT MAK (MINI ACCESS KIT)
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K031691(ABBREVIATED)
ATTN: JERRIE HENDRICKSON PHONE NO : 801-208-4119
1600 WEST MERIT PKWY. SE DECISION MADE: 03-SEP-03
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VP-1000; MED CAM 100; VP-3000A; MED CAM 300
MGB ENDOSKOPISCHE GERATE GMBH (BER510(k) NO: K032544(TRADITIONAL)
ATTN: J TSCHEPE PHONE NO : 490 306 3927000
SCHWARZSCHILDSTRASSE 6 SE DECISION MADE: 02-SEP-03
BERLIN, GERMANY 12489 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ENDOSCOPIC LIGHT SOURCE LS-3000X; LS-1800XG/MED LIGHT X 180; LS-
MGB ENDOSKOPISCHE GERATE GMBH (BER510(k) NO: K032545(TRADITIONAL)
ATTN: JOHANNES TSCHEPE PHONE NO : 49 030 63927000
SCHWARZSCHILDSTRASSE 6 SE DECISION MADE: 02-SEP-03
BERLIN, GERMANY 12489 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HALM ZIELKE INSTRUMENTATION SYSTEM
MICOMED ORTHO GMBH 510(k) NO: K024125(TRADITIONAL)
ATTN: CORRINE M BONFIGLIO PHONE NO : 858-342-0344
13195 SEAGROVE ST. SE DECISION MADE: 22-SEP-03
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E275
MICRO CURRENT TECHNOLOGY, INC. 510(k) NO: K032653(TRADITIONAL)
ATTN: DAVID SUZUKI PHONE NO : 800-976-2544
4822 CALIFORNIA AVE., S.W., SE DECISION MADE: 12-SEP-03
SUITE 201 510(k) STATEMENT
SEATTLE, WA 98116 THIRD PARTY REVIEW
DEVICE: SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT
MICRO THERAPEUTICS, INC. 510(k) NO: K032497(SPECIAL)
ATTN: FLORIN TRUUVENT PHONE NO : 949-837-3700
2 GOODYEAR SE DECISION MADE: 25-SEP-03
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921
MICROLIFE CORP. 510(k) NO: K030961(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD. SE DECISION MADE: 12-SEP-03
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: MICROLIFE DIGITAL UNDERARM ELECTRONIC THERMOMETER, MODEL MT 18E1
MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K032364(ABBREVIATED)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 23-SEP-03
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROLIFE MODEL MT18E1-1 (V932-1) DIGITAL UNDERARM ELECTRONIC TH
MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K032658(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 11-SEP-03
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MICRUS MICROCATHETER
MICRUS CORP. 510(k) NO: K032624(TRADITIONAL)
ATTN: MARGARET WEBBER PHONE NO : 408-830-5900
610 PALOMAR AVENUE SE DECISION MADE: 10-SEP-03
MOUNTAIN VIEW, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: COMPOSITE RESTORATION MATERIAL
MILTON HODOSH, M.D. 510(k) NO: K031721(TRADITIONAL)
ATTN: MILTON HODOSH PHONE NO : 401-781-3591
243 ELWOOD AVE. SE DECISION MADE: 11-SEP-03
PROVIDENCE, RI 02907 510(k) STATEMENT
DEVICE: HRK-63-8 KNEE ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K032633(SPECIAL)
ATTN: TOM SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SE DECISION MADE: 25-SEP-03
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: DIAMOND D HIGH IMPACT DENTURE ACRYLIC
MYCONE DENTAL SUPPLY CO., INC. 510(k) NO: K032773(SPECIAL)
ATTN: LARRY STEFFIER PHONE NO : 856-663-4700
616 HOLLYWOOD AVE. SE DECISION MADE: 23-SEP-03
CHERRY HILL, NJ 08002 510(k) STATEMENT
DEVICE: VASCUPUNCTURE PICC GUIDEWIRE
NEO METRICS, INC. 510(k) NO: K031652(TRADITIONAL)
ATTN: GENE CHAMPEAU PHONE NO : 763-559-4440
14800 28TH AVENUE NORTH SE DECISION MADE: 30-SEP-03
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
PLYMOUTH, MN 55447
DEVICE: TWISTER SUPERELASTIC LIGATING CLIP AND APPLIER
NEUROSEL (MEDICAL) LIMITED 510(k) NO: K032238(TRADITIONAL)
ATTN: PETER GIBSON PHONE NO : 44 126 4711080
GREENWAYS SE DECISION MADE: 09-SEP-03
ABBOTTS ANN 510(k) SUMMARY AVAILABLE FROM FDA
ANDOVER, HAMPSHIRE, UNITED KINGDOM SP11 7BH
DEVICE: BEDSIDE MONITOR, MODEL OPV-1500
NIHON KOHDEN AMERICA, INC. 510(k) NO: K032749(SPECIAL)
ATTN: SERRAH NAMINI PHONE NO : 949-580-1555
90 ICON ST. SE DECISION MADE: 16-SEP-03
FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENCLOSE II ANASTOMOSIS ASSIST DEVICE
NOVARE SURGICAL SYSTEMS, INC. 510(k) NO: K032589(SPECIAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LN. SE DECISION MADE: 05-SEP-03
SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANT HILL, CA 94523-3389
DEVICE: NUMED TYSHAK MINI PEDIATRIC PTV CATHETER
NUMED, INC. 510(k) NO: K032591(SPECIAL)
ATTN: NICHELLE R LAFLESH PHONE NO : 315-328-4491
2880 MAIN ST. SE DECISION MADE: 25-SEP-03
HOPKINTON, NY 12965 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENTACAM SCHEIMPFLUG CAMERA
OCULUS OPTIKGERATE GMBH 510(k) NO: K030719(TRADITIONAL)
ATTN: TOM WEATHERBY PHONE NO : 425-867-1800
18902 NE 150TH ST. SE DECISION MADE: 16-SEP-03
WOODINVILLE, WA 98072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLESTAR N-20
ODIN MEDICAL TECHNOLOGIES LTD. 510(k) NO: K032541(SPECIAL)
ATTN: EINAV SHLOMOVITZ PHONE NO : 972 495 91010
P.O BOX 548 SE DECISION MADE: 12-SEP-03
YOKNEAM ELIT, ISRAEL 20692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS ULTRASONIC SURGICAL SYSTEM
OLYMPUS OPTICAL CO., LTD. 510(k) NO: K031305(TRADITIONAL)
ATTN: TINA STEFFANIE-OAK PHONE NO : 631-844-5477
TWO CORPORATE CENTER DR. SE DECISION MADE: 23-SEP-03
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERSONNA PLUS SAFETY SCALPEL SYSTEM
OMI MANUFACTURING PTY., LTD. 510(k) NO: K032242(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 23-SEP-03
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CAL
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K031031(TRADITIONAL)
ATTN: ANN M QUINN PHONE NO : 585-453-4152
100 INDIGO CREEK DR. SE DECISION MADE: 29-SEP-03
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOMED ALVEOLAR DISTRACTION SYSTEM
OSTEOMED L.P. 510(k) NO: K030790(TRADITIONAL)
ATTN: DAWN T HOLDEMAN PHONE NO : 972-677-4600
3885 ARAPAHO RD. SE DECISION MADE: 10-SEP-03
ADDISON, TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILE POWDER FREE SYNTHETIC SURGICAL GLOVE WITH POLYMER COATIN
P.T. SAPTINDO SURGICA 510(k) NO: K031669(TRADITIONAL)
ATTN: WIDAGDO GONDOWARDOYO PHONE NO : 62 021 58350070
JALAN RAYA SERANG KM 65, SE DECISION MADE: 23-SEP-03
CIKANDE 510(k) STATEMENT
SERANG-BANTEN, INDONESIA 42186
DEVICE: STERILE POWDER FREE LATEX SURGICAL GLOVE WITH POLYMER COATING
P.T. SAPTINDO SURGICA 510(k) NO: K031670(TRADITIONAL)
ATTN: WIDAGDO GONDOWARDOYO PHONE NO : 62 021 58350070
JALAN RAYA SERANG KM 65, SE DECISION MADE: 23-SEP-03
CIKANDE 510(k) STATEMENT
SERANG-BANTEN, INDONESIA 42186
DEVICE: COMP. E
PARKELL, INC. 510(k) NO: K032179(TRADITIONAL)
ATTN: NELSON J GENDUSA PHONE NO : 631-249-1134
155 SCHMITT BLVD. SE DECISION MADE: 09-SEP-03
P.O. BOX 376 510(k) SUMMARY AVAILABLE FROM FDA
FARMINGDALE, NY 11735
DEVICE: INTERA-SENSATION FAMILY
PHILIPS MEDICAL SYSTEMS 510(k) NO: K031815(TRADITIONAL)
ATTN: LYNN HARMER PHONE NO : 425-487-7312
22100 BOTHELL EVERETT HWY SE DECISION MADE: 10-SEP-03
P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98041-8431
DEVICE: DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM MODEL, C3 COLOR AND C3
PLANAR SYSTEMS, INC. 510(k) NO: K032638(TRADITIONAL)
ATTN: SUSAN HAMANN PHONE NO : 781-895-1155
400 FIFTH AVENUE SE DECISION MADE: 11-SEP-03
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: LATEX ULTRASONIC PROBE COVER
PLEASURE LATEX PRODUCTS SDN. BHD. 510(k) NO: K022156(ABBREVIATED)
ATTN: KOI-YONG LIM PHONE NO : 603 326 40784
LOT 1365, 17TH MILES, JALAN SE DECISION MADE: 11-SEP-03
SUNGAI SEMBILANG 510(k) STATEMENT
JERAM, SELANGOR DARUL EHSAN, MALAYSIA 45800
DEVICE: IP-XS COMPRESSION NAIL SYSTEM
PLUS ORTHOPEDICS 510(k) NO: K032548(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 10-SEP-03
ROUND ROCK, TX 78681-2700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODULAR PLUS HIP STEM
PLUS ORTHOPEDICS 510(k) NO: K032709(SPECIAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 23-SEP-03
ROUND ROCK, TX 78681-2700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16
PM DEVICES, INC. 510(k) NO: K031948(TRADITIONAL)
ATTN: BRITTA DOMBOVARI PHONE NO : 604 270 4344
2135-13700 MAYFIELD PLACE SE DECISION MADE: 16-SEP-03
RICHMOND, BC, CANADA V6V 2E4 510(k) STATEMENT
DEVICE: PARAPAC 200D TRANSPORT, MODEL V200D
PNEU PAC, LTD. 510(k) NO: K030803(TRADITIONAL)
ATTN: DONALD ALEXANDER PHONE NO : 262-542-3100
SMITHS MEDICAL SE DECISION MADE: 29-SEP-03
N7 W22025 JOHNSON ROAD 510(k) SUMMARY AVAILABLE FROM FDA
WAUKESHA, WI 53186-1856
DEVICE: BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE
PORTEX LTD. 510(k) NO: K030570(TRADITIONAL)
ATTN: STEVE OGILVIE PHONE NO : 00 44 1303208011
MILITARY ROAD SE DECISION MADE: 17-SEP-03
HYTH, KENT, UNITED KINGDOM CT21 6D510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, C
POWER MEDICAL INTERVENTIONS, INC. 510(k) NO: K032701(SPECIAL)
ATTN: BARBARA J WHITMAN PHONE NO : 267-775-8151
110 UNION SQUARE DR. SE DECISION MADE: 30-SEP-03
NEW HOPE PA, PA 18938 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER
PRECISION VASCULAR SYSTEMS, INC. 510(k) NO: K032494(SPECIAL)
ATTN: RICK GAYKOWSKI PHONE NO : 801-974-1736
2405 WEST ORTON CIR. SE DECISION MADE: 05-SEP-03
WEST VALLEY CITY, UT 84119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, A
PRINCETON BIOMEDITECH CORP. 510(k) NO: K023837(TRADITIONAL)
ATTN: JEMO KANG PHONE NO : 732-274-1000
4242 U.S. RT. 1 SE DECISION MADE: 15-SEP-03
MONMOUTH JUNCTION, NJ 08852-1905 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL IMAGER
PYRAMID MEDICAL, INC. 510(k) NO: K032022(TRADITIONAL)
ATTN: CLAUDE BENNETT PHONE NO : 714-826-2777
10940 PORTAL MEDICAL DR. SE DECISION MADE: 02-SEP-03
LOS ALAMITOS, CA 90720 510(k) STATEMENT
DEVICE: BPCARD
QRS DIAGNOSTIC, LLC. 510(k) NO: K031964(TRADITIONAL)
ATTN: MARY KAY JENSEN PHONE NO : 763-559-8492
14755 27TH AVE.NORTH SE DECISION MADE: 05-SEP-03
PLYMOUTH, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTUM WARP 10 LIGHT DELIVERY SYSTEM
QUANTUM DEVICES, INC. 510(k) NO: K032229(TRADITIONAL)
ATTN: MICHELE H VOVOLKA PHONE NO : 847-856-0355
PO BOX 848 SE DECISION MADE: 12-SEP-03
GRAYSLAKE, IL 60030 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AML HAIRCHECK-DT (COCAINE)
QUEST DIAGNOSTICS, INC. 510(k) NO: K023626(TRADITIONAL)
ATTN: PATRICK CARPENTER PHONE NO : 702-733-7866
4230 BURNHAM AVE. SE DECISION MADE: 29-SEP-03
LAS VEGAS, NV 89119-5410 510(k) STATEMENT
DEVICE: QUICKVUE INFLUENZA A+B TEST
QUIDEL CORP. 510(k) NO: K031899(TRADITIONAL)
ATTN: ROBIN WEINER PHONE NO : 858-552-7908
10165 MCKELLAR CT. SE DECISION MADE: 11-SEP-03
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601
QUINTON, INC. 510(k) NO: K032038(ABBREVIATED)
ATTN: KAREN BROWNE PHONE NO : 425-402-2255
3303 MONTE VILLA PKWY. SE DECISION MADE: 05-SEP-03
BOTHELL, WA 98021-8906 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE
RADIONICS, A DIVISION OF TYCO HEAL510(k) NO: K032054(TRADITIONAL)
ATTN: KEVIN J O'CONNELL PHONE NO : 781-272-1233
22 TERRY AVE. SE DECISION MADE: 15-SEP-03
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RATTAN IMACS BY RATTAN INFORMATION CORPORATION
RATTAN INFORMATION CORPORATION 510(k) NO: K032176(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1100 LAKEVIEW BLVD. SE DECISION MADE: 25-SEP-03
DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXTENDED RANGE HS CRP KIT, CAT NO:9200
REFERENCE DIAGNOSTICS, INC. 510(k) NO: K030044(TRADITIONAL)
ATTN: JOSEPH LAWLOR PHONE NO : 781-276-9000
19 CROSBY DR. SUITE 30 SE DECISION MADE: 30-SEP-03
BEDFORD, MA 01730 510(k) STATEMENT
DEVICE: SORB+HISORB+CARTRIDGE
RENAL SOLUTIONS, INC. 510(k) NO: K031099(TRADITIONAL)
ATTN: RICHARD G CONFER PHONE NO : 724-334-3223
1010 MEADOWVIEW DR. SE DECISION MADE: 17-SEP-03
APOLLO, PA 15613 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHORT INTRODUCER SHEATH
REX MEDICAL 510(k) NO: K032569(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD. SE DECISION MADE: 16-SEP-03
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760
RHIGENE, INC. 510(k) NO: K031308(TRADITIONAL)
ATTN: NANCI DEXTER PHONE NO : 303-457-4345
12061 TEJON ST. SE DECISION MADE: 26-SEP-03
WESTMINSTER, CO 80234 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR
RITA MEDICAL SYSTEMS INC 510(k) NO: K032149(TRADITIONAL)
ATTN: KAREN J FRISCHMEYER PHONE NO : 650-314-3416
967 N. SHORELINE BLVD. SE DECISION MADE: 09-SEP-03
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ONLINE TDM CARBAMAZEPINE
ROCHE DIAGNOSTICS CORP. 510(k) NO: K031902(TRADITIONAL)
ATTN: KERWIN KAUFMAN PHONE NO : 317-521-7637
9115 HAGUE RD. SE DECISION MADE: 17-SEP-03
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS
ROCHE DIAGNOSTICS CORP. 510(k) NO: K032535(SPECIAL)
ATTN: SHERRI L COENEN PHONE NO : 317-521-3831
9115 HAGUE RD. SE DECISION MADE: 10-SEP-03
PO BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0457
DEVICE: ACCU-CHEK ADVANTAGE SYSTEM
ROCHE DIAGNOSTICS CORP. 510(k) NO: K032552(SPECIAL)
ATTN: SCOTT THIEL PHONE NO : 800-428-5074
9115 HAGUE RD. SE DECISION MADE: 12-SEP-03
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROWENTA INC. BODYPARTNER VISION, MODEL BM 210 (2079565620)
ROWENTA, INC. 510(k) NO: K023429(TRADITIONAL)
ATTN: JONES STEVE PHONE NO : 781-396-0600
196 BOSTON AVE. SE DECISION MADE: 23-SEP-03
MEDFORD, MA 02155 510(k) STATEMENT
DEVICE: RS-4I MUSCLE STIMULATOR FAMILY
RS MEDICAL 510(k) NO: K032652(TRADITIONAL)
ATTN: MICHAEL B MCGRAW PHONE NO : 360-896-2503
14401 S.E. FIRST ST. SE DECISION MADE: 12-SEP-03
VANCOUVER, WA 98684 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629
RUBICOR MEDICAL, INC. 510(k) NO: K032584(SPECIAL)
ATTN: ROBERT J CHIN PHONE NO : 650-593-5225
25 HARTFORD AVE. SE DECISION MADE: 17-SEP-03
SAN CARLOS, CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S&T; MICROSURGICAL SUTURE
S & T AG 510(k) NO: K031531(TRADITIONAL)
ATTN: BERNHARD TEITZ PHONE NO : 847-549-1410
28438 BALLARD DR. SE DECISION MADE: 23-SEP-03
LAKE FOREST, IL 60045 510(k) STATEMENT
DEVICE: S-MONOVETTE EDTA K2-GEL
SARSTEDT, INC. 510(k) NO: K031359(TRADITIONAL)
ATTN: PETER RUMSWINKEL PHONE NO : 828-465-4000
1025 ST. JAMES CHURCH RD. SE DECISION MADE: 12-SEP-03
NEWTON, NC 28658 510(k) STATEMENT
DEVICE: SAFETY-MULTIFLY
SARSTEDT, INC. 510(k) NO: K032150(TRADITIONAL)
ATTN: PETER RUMSWINKEL PHONE NO : 828-465-4000
1025 ST. JAMES CHURCH RD. SE DECISION MADE: 12-SEP-03
PO BOX 468 510(k) STATEMENT
NEWTON, NC 28658
DEVICE: GEL MARK III BIOPSY SITE MARKER
SENORX, INC. 510(k) NO: K031938(TRADITIONAL)
ATTN: AMY BOUCLY PHONE NO : 949-362-4800
11 COLUMBIA, SUITE A SE DECISION MADE: 05-SEP-03
ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
SHIJIAZHUANG GREAT VISION PLASTIC 510(k) NO: K031108(TRADITIONAL)
ATTN: JAMES CHU PHONE NO : 714-990-6888
590 W. CENTRAL AVE # D SE DECISION MADE: 08-SEP-03
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VINTAGE AL
SHOFU DENTAL CORP. 510(k) NO: K032165(TRADITIONAL)
ATTN: ROBERT NOBLE PHONE NO : 760-736-3277
1225 STONE DR. SE DECISION MADE: 16-SEP-03
SAN MARCOS, CA 92069-4059 510(k) STATEMENT
DEVICE: SIREMOBIL ISO-C 3D
SIEMENS AG 510(k) NO: K032280(ABBREVIATED)
ATTN: NEALIE HARTMAN PHONE NO : 610-448-1779
51 VALLEY STREAM PARKWAY SE DECISION MADE: 10-SEP-03
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E
SIEMENS ELEMA AB 510(k) NO: K023354(TRADITIONAL)
ATTN: STEVE SHEEHAN PHONE NO : 978-907-6391
16 ELECTRONICS AVE. SE DECISION MADE: 05-SEP-03
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K031764(TRADITIONAL)
ATTN: KEN NEHMER PHONE NO : 925-602-8011
4040 NELSON AVE. SE DECISION MADE: 05-SEP-03
CONCORD, CA 94520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINITY MEGACARE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K031970(TRADITIONAL)
ATTN: PENELOPE GRECO PHONE NO : 978-907-7503
16 ELECTRONICS AVE. SE DECISION MADE: 09-SEP-03
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMUPLAN TREATMENT PLANNING SYSTEM, MODEL V. 7.5
SIMUPLAN S.L. 510(k) NO: K030821(TRADITIONAL)
ATTN: CONRADO PLA PHONE NO : 349 627 43827
MIGUEL HERNANDEZ 25 SE DECISION MADE: 17-SEP-03
LA ELIANA VALENCIA, SPAIN 46183 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SALINUM, ORCLAIR
SINCLAIR PHARMACEUTICALS, LTD. 510(k) NO: K024148(TRADITIONAL)
ATTN: DENISE SWIFT PHONE NO : 441 483 428611
BOROUGH RD. SE DECISION MADE: 15-SEP-03
GODALMING, SURREY, UNITED KINGDOM 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW 300XL XENON LIGHT SOURCE-HERMES READY MODEL, 7210
SMITH & NEPHEW, INC. 510(k) NO: K032680(SPECIAL)
ATTN: DEBORAH CONNORS PHONE NO : 978-749-1495
150 MINUTEMAN RD. SE DECISION MADE: 26-SEP-03
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIOBEAM 830
SOFT-CORE TEXAS, INC. 510(k) NO: K031499(TRADITIONAL)
ATTN: ROY MARTIN PHONE NO : 888-462-8878
5424 RUFE SNOW DR., #102 SE DECISION MADE: 16-SEP-03
NORTH RICHLAND HILLS, TX 76180 510(k) STATEMENT
DEVICE: SOLARC/SOLRX 500 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMIL
SOLARC SYSTEMS, INC. 510(k) NO: K031800(TRADITIONAL)
ATTN: BRUCE ELLIOTT PHONE NO : 705 739 8279
12 PARKER COURT SE DECISION MADE: 10-SEP-03
BARRIE, ONTARIO, CANADA L4N 2A6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOPRO 61D
SOPRO 510(k) NO: K031593(TRADITIONAL)
ATTN: PIERRE MONTILLOT PHONE NO : 33 49 1270727
PLACE ST. CHRISTOPHE SE DECISION MADE: 16-SEP-03
LES ACCATES-LA VALENTINE 510(k) SUMMARY AVAILABLE FROM FDA
MARSEILLE, FRANCE F-13011
DEVICE: SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM
SPINAL CONCEPTS, INC. 510(k) NO: K031855(TRADITIONAL)
ATTN: LISA PETERSON PHONE NO : 512-533-1080
5301 RIATA PARK CT., BLDG. F SE DECISION MADE: 17-SEP-03
AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM
SPINAL CONCEPTS, INC. 510(k) NO: K031985(TRADITIONAL)
ATTN: LISA PETERSON PHONE NO : 512-533-1080
5301 RIATA PARK CT., BLDG. F SE DECISION MADE: 11-SEP-03
AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFETYWAND DISPOSABLE HANDPIECE
SPINTECH, INC. 510(k) NO: K023722(TRADITIONAL)
ATTN: DANIEL J MANELLI PHONE NO : 202-261-1000
2000 M ST. NW SUITE 700 SE DECISION MADE: 02-SEP-03
WASHINGTON, DC 20036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRESCENT TINNITUS RETAINING SOUND GENERATOR
STARKEY LABORATORIES, INC. 510(k) NO: K030180(TRADITIONAL)
ATTN: SCOTT LAPOINTE PHONE NO : 952-828-6952
6700 WASHINGTON AVE. SOUTH SE DECISION MADE: 17-SEP-03
EDEN PRAIRIE, MN 55344 510(k) STATEMENT
DEVICE: PROCLASS PRESS FIT HIP STEM
STELKAST COMPANY 510(k) NO: K032110(TRADITIONAL)
ATTN: DONALD A STEVENS PHONE NO : 724-941-6368
200 HIDDEN VALLEY RD. SE DECISION MADE: 22-SEP-03
MCMURRAY, PA 15317 510(k) STATEMENT
DEVICE: UNIVERSAL NEURO SYSTEM
STRYKER INSTRUMENTS 510(k) NO: K031659(TRADITIONAL)
ATTN: WADE T RUTKOSKIE PHONE NO : 269-323-4226
4100 EAST MILHAM AVE. SE DECISION MADE: 10-SEP-03
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE
SUTURTEK INCORPORATED 510(k) NO: K032468(TRADITIONAL)
ATTN: DEBBIE IAMPIETRO PHONE NO : 508-259-7374
7 TIFFANY TRAIL SE DECISION MADE: 23-SEP-03
HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENVISION
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K032042(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVE. SE DECISION MADE: 29-SEP-03
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) NEW/STERIAL ORBITAL PLATES
SYNTHES (USA) 510(k) NO: K031761(TRADITIONAL)
ATTN: LISA BOYLE PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 03-SEP-03
POST OFFICE BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAF
SYNTHES (USA) 510(k) NO: K031973(TRADITIONAL)
ATTN: BONNIE J SMITH PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 05-SEP-03
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES
SYNTHES (USA) 510(k) NO: K032032(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 04-SEP-03
POST OFFICE BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES
SYNTHES (USA) 510(k) NO: K032269(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 17-SEP-03
P.O. BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100
SYSMEX AMERICA, INC. 510(k) NO: K032039(TRADITIONAL)
ATTN: NINA M GAMPERLING PHONE NO : 847-996-4675
ONE NELSON C. WHITE PARKWAY SE DECISION MADE: 08-SEP-03
MUNDELEIN, IL 60060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRESSSKIN
TEI BIOSCIENCES INC. 510(k) NO: K023778(ABBREVIATED)
ATTN: KENNETH JAMES PHONE NO : 617-268-1616
7 ELKINS ST. SE DECISION MADE: 29-SEP-03
BOSTON, MA 02127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIR PRESS MASSAGER
TELEBRANDS CORP 510(k) NO: K032505(TRADITIONAL)
ATTN: DONALD E SEGAL PHONE NO : 202-452-7959
1776 K STREET, N.W. SUITE 800 SE DECISION MADE: 24-SEP-03
WASHINGTON, DC 20006-2365 510(k) STATEMENT
DEVICE: TELEMIS-MEDICAL SOLUTION
TELEMIS S.A. 510(k) NO: K032157(TRADITIONAL)
ATTN: THOMAS J BOUCHARD PHONE NO : 240-631-8558
7560 LINDBERGH DRIVE SE DECISION MADE: 24-SEP-03
GAITHERSBURG, MD 20879 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BINDAZYME CLQ CIC EIA KIT
THE BINDING SITE, LTD. 510(k) NO: K031563(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 10-SEP-03
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME
THE BINDING SITE, LTD. 510(k) NO: K032240(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 29-SEP-03
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP
THE FIRST YEARS, INC. 510(k) NO: K032566(SPECIAL)
ATTN: ROBIN C CONNOR PHONE NO : 508-588-1220
ONE KIDDIE DR. SE DECISION MADE: 15-SEP-03
AVON, MA 02322 510(k) STATEMENT
DEVICE: APAX PACS SYSTEM
TIS, INC. 510(k) NO: K032760(TRADITIONAL)
ATTN: RONALD D ARKIN PHONE NO : 770-565-6166
1733 CANTON LANE SE DECISION MADE: 17-SEP-03
MARIETTA, GA 30062 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TMC ELECTRICAL SCOOTER, EASY 405
TMC TECHNOLOGY CORP. 510(k) NO: K031313(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 04-SEP-03
HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: TMC ELECTRICAL SCOOTER, EASY 411
TMC TECHNOLOGY CORP. 510(k) NO: K031314(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 04-SEP-03
HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: TMC ELECTRICAL SCOOTER, EASY 321
TMC TECHNOLOGY CORP. 510(k) NO: K031315(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 04-SEP-03
HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: GLYCOMARK
TOMEN AMERICA INC. 510(k) NO: K031604(TRADITIONAL)
ATTN: ERIKA B AMMIRATI PHONE NO : 212-397-4600
1285 AVENUE OF THE AMERICAS SE DECISION MADE: 22-SEP-03
NEW YORK, NY 10019-6028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TORAYSULFONE DIALYZER, BS-L SERIES
TORAY INDUSTRIES (AMERICA), INC. 510(k) NO: K030050(TRADITIONAL)
ATTN: LISA S JONES PHONE NO : 713-664-6775
540 COLLEGE ST. SE DECISION MADE: 29-SEP-03
BELLAIRE, TX 77401-5010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM
U-SYSTEMS, INC. 510(k) NO: K032640(TRADITIONAL)
ATTN: SHEILA W PICKERING PHONE NO : 650-969-6114
2081 LONGDEN CIRCLE SE DECISION MADE: 11-SEP-03
LOS ALTOS,, CA 94204 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MEDRO SPD
U.S. FILTER/IONPURE, INC. 510(k) NO: K030652(TRADITIONAL)
ATTN: ROBERT DUDEK PHONE NO : 978-614-7359
10 TECHNOLOGY DR. SE DECISION MADE: 03-SEP-03
LOWELL, MA 01851 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: U.S. TECHNOLOGIES, INC. RETRACTABLE SAFETY SYRINGE
U.S. TECHNOLOGIES, INC. 510(k) NO: K032247(TRADITIONAL)
ATTN: ROSINA ROBINSION PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 30-SEP-03
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMOSKIN CONDUCTIVE PADS
UNITED PACIFIC, INC. 510(k) NO: K030564(TRADITIONAL)
ATTN: KEVIN OUTRED PHONE NO : 803-735-0034
400 NORTHEAST DR., UNIT F SE DECISION MADE: 12-SEP-03
20/21 BUSINESS CENTER, UNIT F 510(k) STATEMENT
COLUMBIA, SC 29203
DEVICE: 3.0T 8-CHANNEL CERVICAL-THORACIC-LUMBAR (CTL) ARRAY COIL
USA INSTRUMENTS, INC. 510(k) NO: K032538(SPECIAL)
ATTN: CHRISTIE SHUMAKER PHONE NO : 330-562-1000
1515 DANNER DR. SE DECISION MADE: 12-SEP-03
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3.0T 8 CHANNEL NEUROVASCULAR (NV) ARRAY COIL
USA INSTRUMENTS, INC. 510(k) NO: K032618(SPECIAL)
ATTN: CHRISTIE SHUMAKER PHONE NO : 330-995-8572
1515 DANNER DR. SE DECISION MADE: 12-SEP-03
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D-STAT-DRY HEMOSTATIC BANDAGE; D-STAT RADIAL HEMOSTATIC BANDAGE
VASCULAR SOLUTIONS, INC. 510(k) NO: K030836(TRADITIONAL)
ATTN: DEBORAH JENSEN PHONE NO : 763-656-4349
2495 XENIUM LN. NORTH SE DECISION MADE: 17-SEP-03
MINNEAPOLIS, MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATHWAY ACCESS SHEATH CATHETER
VERTELINK CORPORATION 510(k) NO: K030662(TRADITIONAL)
ATTN: ALBERT REGO PHONE NO : 949-770-8710
27001 LA PAZ SUITE 312 SE DECISION MADE: 03-SEP-03
MISSION VIEJO, CA 92691 510(k) STATEMENT
DEVICE: PATHWAY ACCESS SHEATH CATHETER
VERTELINK CORPORATION 510(k) NO: K030734(TRADITIONAL)
ATTN: ALBERT REGO PHONE NO : 949-770-8710
27001 LA PAZ SUITE 312 SE DECISION MADE: 10-SEP-03
MISSION VIEJO, CA 92691 510(k) STATEMENT
DEVICE: IRRIGATION SETS
VITAL CONCEPTS, INC. 510(k) NO: K032832(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 26-SEP-03
CROFTON, MD 21114 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: WARTNER WART REMOVAL SYSTEM, MODEL 66715 82000 (PRODUCT CODE NUM
WARTNER USA B.V. 510(k) NO: K032271(TRADITIONAL)
ATTN: NANCY LUM-WILSON PHONE NO : 905 884 7855
65 AVA CRESCENT SE DECISION MADE: 10-SEP-03
RICHMOND HILL, ONTARIO, CANADA L4B510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONE DIMENSIONAL WATER PHANTOM, WP 1D
WELLHOFER DOSIMETRIE 510(k) NO: K032594(TRADITIONAL)
ATTN: MARK MARSICO PHONE NO : 901-386-2242
3150 STAGE POST DR. SE DECISION MADE: 05-SEP-03
SUITE 110 510(k) SUMMARY AVAILABLE FROM FDA
BARTLETT, TN 38133 THIRD PARTY REVIEW
DEVICE: ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER
WFR/AQUAPLAST CORP. 510(k) NO: K032156(TRADITIONAL)
ATTN: J. DAMON KIRK PHONE NO : 201-891-1042
30 LAWLINS PARK SE DECISION MADE: 02-SEP-03
WYCKOFF, NJ 07481 510(k) STATEMENT
DEVICE: F-11 FOLDING POWER CHAIR
WHEELCHAIR & SCOOTER EXPRESS 510(k) NO: K032440(TRADITIONAL)
ATTN: CHRIS TINSLEY PHONE NO : 620-325-2629
4905 A. SAN JACINTO SE DECISION MADE: 23-SEP-03
HOUSTON, TX 77004 510(k) STATEMENT
DEVICE: WU'S 4-WHEELED NEO SCOOTER, WT-M4JR
WU'S TECH CO., LTD. 510(k) NO: K032489(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 24-SEP-03
HSIN-CHU CITY, CHINA (TAIWAN) ROC 510(k) STATEMENT
TOTAL 510(k)s THIS PERIOD 290
TOTAL WITH SUMMARIES 230
TOTAL WITH STATEMENTS 60
Updated October 6, 2003
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