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510(k)s Final Decisions Rendered for July 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-JUL-2003 THROUGH 31-JUL-2003
DEVICE: STEREOTACTIC BODY FRAME, MODEL COD. 70-1A
3D LINE USA, INC. 510(k) NO: K031631(TRADITIONAL)
ATTN: NADER SALEHI PHONE NO : 410-581-6701
11419 CROWNRIDGE RD., STE.15 SE DECISION MADE: 18-JUL-03
OWINGS MILLS, MD 21117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C-REACTIVE PROTEIN (CRP)
ABBOTT LABORATORIES 510(k) NO: K030899(TRADITIONAL)
ATTN: LINDA MORRIS PHONE NO : 972-518-6711
1920 HURD DR. SE DECISION MADE: 02-JUL-03
IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE
ACMI CORPORATION 510(k) NO: K030960(TRADITIONAL)
ATTN: JOHN DELUCIA PHONE NO : 508-804-2617
136 TURNPIKE RD. SE DECISION MADE: 16-JUL-03
SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON STREP A RAPID TEST DEVICE
ACON LABORATORIES, INC. 510(k) NO: K031784(SPECIAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2038
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 14-JUL-03
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: DIGITAL CLINICAL THERMOMETER, MODELS ACT2130, ACT 2230, ACT 2330
ACTHERM, INC. 510(k) NO: K031905(SPECIAL)
ATTN: RICHARD HSIEH PHONE NO : 886 3 5537315
6TH F, NO 85 SE DECISION MADE: 07-JUL-03
KUAN-MIN 6 ROAD JUBEI 302 510(k) STATEMENT
HSINCHU, CHINA (TAIWAN) 302
DEVICE: ACUMED SMALL BONE LOCKING ROD SYSTEM II
ACUMED LLC 510(k) NO: K031438(TRADITIONAL)
ATTN: ED BOEHMER PHONE NO : 503-627-9957
5885 NW CORNELIUS PASS RD. SE DECISION MADE: 17-JUL-03
HILLSBORO, OR 97124-9432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: "FAST THROW" STAINLESS STEEL SURGICAL SUTURE
ADVANCED SURGICAL PRODUCTS, INC. 510(k) NO: K030926(TRADITIONAL)
ATTN: JEFFERY S JONES PHONE NO : 650-207-6987
681 MANZANITA AVE. SE DECISION MADE: 21-JUL-03
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTUR
AESCULAP 510(k) NO: K031216(TRADITIONAL)
ATTN: GEORG KELLER PHONE NO : 800-258-1946
3773 CORPORATE PKWY. SE DECISION MADE: 17-JUL-03
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO MACS MODULAR ANTERIOR CONSTRUCT SYSTEM
AESCULAP, INC. 510(k) NO: K032059(SPECIAL)
ATTN: GEORG KELLER PHONE NO : 610-797-9300
3773 CORPORATE PKWY. SE DECISION MADE: 25-JUL-03
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATIO
ALARIS MEDICAL SYSTEMS, INC. 510(k) NO: K032147(SPECIAL)
ATTN: STACY L LEWIS PHONE NO : 858-458-7830
10221 WATERIDGE CIR. SE DECISION MADE: 25-JUL-03
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION
ALCON, INC. 510(k) NO: K031193(TRADITIONAL)
ATTN: KIM B KRACKE PHONE NO : 817-551-8338
6201 SOUTH FREEWAY SE DECISION MADE: 03-JUL-03
FORT WORTH, TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES
ALLIANCE MEDICAL CORP. 510(k) NO: K032058(SPECIAL)
ATTN: MOIRA BARTON PHONE NO : 480-763-5300
10232 SOUTH 51ST ST. SE DECISION MADE: 30-JUL-03
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE
AMERICAN SYRINGE COMPANY 510(k) NO: K031394(TRADITIONAL)
ATTN: DAVID M GARVIN PHONE NO : 305-371-8166
1200 BRICKELL AVE. SE DECISION MADE: 25-JUL-03
SUITE 1480 510(k) STATEMENT
MIAMI, FL 33131
DEVICE: AMERITEK SURE-POINT HDR NEEDLE TEMPLATE
AMERTEK MEDICAL, INC. 510(k) NO: K031273(TRADITIONAL)
ATTN: GREG WIITA PHONE NO : 561-842-7595
2655 NORTH OCEAN DR. SE DECISION MADE: 15-JUL-03
SINGER ISLAND, FL 33404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMPLAID A756 SCREENING ADMITTANCE METER
AMPLAID 510(k) NO: K031978(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 21-JUL-03
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWER LASER 90
ANDI ELECTROMEDICAL APS 510(k) NO: K030692(TRADITIONAL)
ATTN: JEFF WORRELL PHONE NO : 800-662-7283
12415 OLD MERIDIAN ST. SE DECISION MADE: 17-JUL-03
CARMEL, IN 46032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A/C ENZYMATIC HOMOCYSTEINE ASSAY
ANTICANCER INC 510(k) NO: K030754(TRADITIONAL)
ATTN: YUYING TAN PHONE NO : 858-654-2555
7917 OSTROW ST. SE DECISION MADE: 11-JUL-03
SAN DIEGO, CA 92111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INJECTOR
ANTON MEYER & CO. LTD. 510(k) NO: K023737(TRADITIONAL)
ATTN: THOMAS MEYER PHONE NO : 41 32 3329111
HELMSTRASSE 1 SE DECISION MADE: 14-JUL-03
NIDAU, SWITZERLAND CH-2560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VINYL EXAMINATION GLOVES, POWDER FREE, VIOLET COLOR
ARISTA LATINDO INDUSTRIAL, LTD. P.510(k) NO: K031913(TRADITIONAL)
ATTN: LINGA SUMARTA PHONE NO : 621 166 20201/195
128 JALAN KYAI HAJI MUHAMMAD SE DECISION MADE: 09-JUL-03
MANSYUR 510(k) STATEMENT
JAKARTA BARAT, INDONESIA 11210
DEVICE: SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE
ASIA-MED GMBH AND CO KG 510(k) NO: K031716(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LN. SE DECISION MADE: 10-JUL-03
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: OSTEO-G BONE VOID FILLER SYSTEM
ASPINE USA, INC. 510(k) NO: K031319(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
4329 GRAYDON RD. SE DECISION MADE: 17-JUL-03
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AURORA
AURORA IMAGING TECHNOLOGY, INC. 510(k) NO: K032082(SPECIAL)
ATTN: JAMES R VEALE PHONE NO : 719-495-3438
49 PLAIN STREET SE DECISION MADE: 30-JUL-03
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DURAMAX .035 BILIARY STENT SYSTEM, MODELS DML0718-80, DML0718-13
AVANTEC VASCULAR CORP. 510(k) NO: K030638(TRADITIONAL)
ATTN: JAMES M SHY PHONE NO : 408-743-3100
1049 KIEL CT. SE DECISION MADE: 09-JUL-03
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFETY INTRODUCER NEEDLE
B. BRAUN MEDICAL, INC. 510(k) NO: K030135(TRADITIONAL)
ATTN: AMY K SMITH PHONE NO : 610-266-0500
901 MARCON BLVD. SE DECISION MADE: 15-JUL-03
ALLENTOWN, PA 18109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B. BRAUN NERVE BLOCK CATHETER
B. BRAUN MEDICAL, INC. 510(k) NO: K030830(TRADITIONAL)
ATTN: PATRICIA D WILSON PHONE NO : 610-266-0500
901 MARCON BLVD. SE DECISION MADE: 15-JUL-03
ALLENTOWN, PA 18109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYLIS PAIN MANAGEMENT GENERATOR, MODELS PMG-115-TD AND PMG-230-
BAYLIS MEDICAL CO., INC. 510(k) NO: K031950(ABBREVIATED)
ATTN: KRIS SHAH PHONE NO : 905 602 4875
5160 EXPLORER DR. #33 SE DECISION MADE: 17-JUL-03
MISSISSAUGA, ONTARIO, CANADA L4W 4510(k) STATEMENT
DEVICE: SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT
BECKMAN COULTER, INC. 510(k) NO: K031870(SPECIAL)
ATTN: MARY BETH TANG PHONE NO : 714-961-3777
200 SOUTH KRAEMER BLVD. SE DECISION MADE: 15-JUL-03
BREA, CA 92822 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER
BECKMAN COULTER, INC. 510(k) NO: K032013(SPECIAL)
ATTN: LOURDES COBA PHONE NO : 305-380-4552
11800 SW 147TH AVE. SE DECISION MADE: 24-JUL-03
MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN-8-512 UG
BECTON DICKINSON & CO. 510(k) NO: K031530(TRADITIONAL)
ATTN: MONICA EVELYN GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 10-JUL-03
SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN GRAM POS
BECTON, DICKINSON AND COMPANY 510(k) NO: K031589(TRADITIONAL)
ATTN: MICHELLE B BANDY PHONE NO : 410-316-4778
7 LOVETON CIR. SE DECISION MADE: 11-JUL-03
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHONENIX AUTOMATED MICROBIOLOGY SYSTEM
BECTON, DICKINSON AND COMPANY 510(k) NO: K031679(TRADITIONAL)
ATTN: BRADFORD SPRING PHONE NO : 410-316-4206
7 LOVETON CIR. SE DECISION MADE: 16-JUL-03
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMET
BECTON, DICKINSON AND COMPANY 510(k) NO: K031699(TRADITIONAL)
ATTN: KATHRYN BABKA POWERS PHONE NO : 410-316-4260
7 LOVETON CIR. SE DECISION MADE: 30-JUL-03
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICRBIOLOGY SYSTEM AMOXICILLIN/CLAVUALANTE
BECTON, DICKINSON AND COMPANY 510(k) NO: K031912(TRADITIONAL)
ATTN: MICHELLE B BANDY PHONE NO : 410-316-4778
7 LOVETON CIR. SE DECISION MADE: 21-JUL-03
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROHEATER
BELMONT INSTRUMENT CORP. 510(k) NO: K031478(TRADITIONAL)
ATTN: URAIWAN P LABADINI PHONE NO : 978-663-0212
780 BOSTON RD. SE DECISION MADE: 02-JUL-03
BILLERICA, MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO-LOGIC INSERT EARPHONES
BIO-LOGIC SYSTEMS CORP. 510(k) NO: K031352(TRADITIONAL)
ATTN: ERIK C GUNDERSEN PHONE NO : 847-949-5200
ONE BIO-LOGIC PLAZA SE DECISION MADE: 16-JUL-03
MUNDELEIN, IL 60060-3700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROFESSIONAL BLOOD SAMPLE RETRIEVAL SYSTEM
BIOMED PERSONAL METABOLIC AND NUTR510(k) NO: K030076(TRADITIONAL)
ATTN: SUSAN B FENTRESS PHONE NO : 901-680-7319
6075 POPLAR AVE. SE DECISION MADE: 07-JUL-03
SUITE 500 510(k) STATEMENT
MEMPHIS, TN 38119
DEVICE: VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE
BIOMERIEUX, INC. 510(k) NO: K031410(TRADITIONAL)
ATTN: NANCY WEAVER PHONE NO : 314-731-8695
595 ANGLUM RD. SE DECISION MADE: 10-JUL-03
HAZELWOOD, MO 63042-2320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BACT/ALERT MP CULTURE BOTTLES (PLASTIC)
BIOMERIEUX, INC. 510(k) NO: K031737(TRADITIONAL)
ATTN: JOCELYN JENNINGS PHONE NO : 919-620-2968
100 RODOLPHE ST. SE DECISION MADE: 14-JUL-03
DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS
BIOMET, INC. 510(k) NO: K031734(SPECIAL)
ATTN: GARY BAKER PHONE NO : 574-372-1568
56 EAST BELL DR. SE DECISION MADE: 01-JUL-03
PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: AIRBRUSH LIPOSCULPTOR SYSTEM
BIOSCULPTURE TECHNOLOGY, INC. 510(k) NO: K031881(TRADITIONAL)
ATTN: ROBERT CUCIN PHONE NO : 212-977-5400
120 CENTRAL PARK SOUTH SE DECISION MADE: 28-JUL-03
NEW YORK, NY 10019 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER
BIOSENSE WEBSTER, INC. 510(k) NO: K031161(SPECIAL)
ATTN: WILLIAM WELCH PHONE NO : 909-839-8604
3333 DIAMOND CANYON RD. SE DECISION MADE: 22-JUL-03
DIAMOND BAR, CA 91765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENERAL SEMEN ANALYSIS (GSA) KIT
BIOSHAF LTD. 510(k) NO: K024337(TRADITIONAL)
ATTN: TOM TSAKERIS PHONE NO : 301-330-2076
16809 BRIARDALE RD. SE DECISION MADE: 03-JUL-03
ROCKVILLE, MD 20855 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRAOS 70
BLUE X IMAGING SRL 510(k) NO: K031118(TRADITIONAL)
ATTN: AL SOSA PHONE NO : 847-459-3889
251 E. DUNDEE RD. SE DECISION MADE: 08-JUL-03
SUITE #6 510(k) SUMMARY AVAILABLE FROM FDA
WHEELING, IL 60090
DEVICE: ULTRAFLEX PRECISION COLONIC STENT
BOSTON SCIENTIFIC CORP. 510(k) NO: K030769(TRADITIONAL)
ATTN: KATHLEEN MORAHAN PHONE NO : 508-652-5942
ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 14-JUL-03
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238
BOSTON SCIENTIFIC CORP. 510(k) NO: K031844(SPECIAL)
ATTN: JODI LYNN GREENIZEN PHONE NO : 518-742-4338
10 GLENS FALLS TECHNICAL PARK SE DECISION MADE: 15-JUL-03
GLENS FALLS, NY 12801-3864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VAXCEL WITH PASV PORT, MODEL 45-213
BOSTON SCIENTIFIC CORP. 510(k) NO: K032008(SPECIAL)
ATTN: JODI LYNN GREENIZEN PHONE NO : 518-742-4338
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 14-JUL-03
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONITECT OXYCODONE DRUG DCREEN CASSETTE TEST, MODEL MC 23, FASTE
BRANAN MEDICAL CORP. 510(k) NO: K030113(TRADITIONAL)
ATTN: RAPHAEL WONG PHONE NO : 949-598-7166
10015 MUIRLANDS RD., SUITE E SE DECISION MADE: 02-JUL-03
IRVINE, CA 92618 510(k) STATEMENT
DEVICE: BRODA MODEL 587 MANUAL WHEELCHAIR
BRODA ENT., INC. 510(k) NO: K032133(TRADITIONAL)
ATTN: PHILLIP MCTAGGART PHONE NO : 541 746 8080
385 PHILLIP ST. SE DECISION MADE: 21-JUL-03
WATERLOO ONTARIO, CANADA N2L 5R8 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY D
C.R. BARD, INC. 510(k) NO: K030268(ABBREVIATED)
ATTN: GLENN NORTON PHONE NO : 801-595-0700
5425 WEST AMELIA EARHART DR. SE DECISION MADE: 30-JUL-03
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
C.R. BARD, INC. 510(k) NO: K030442(TRADITIONAL)
ATTN: RAMON RICART PHONE NO : 801-595-0700
5425 WEST AMELIA EARHART DR. SE DECISION MADE: 21-JUL-03
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RECOVERY FILTER SYSTEM, MODEL RF-048F
C.R. BARD, INC. 510(k) NO: K031328(ABBREVIATED)
ATTN: MARY J EDWARDS PHONE NO : 480-303-2640
1625 WEST 3RD ST. SE DECISION MADE: 25-JUL-03
TEMPE, AZ 85280 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-PROT DUO PORT
C.R. BARD, INC. 510(k) NO: K032044(SPECIAL)
ATTN: JOHN C KNORPP PHONE NO : 801-595-0700
5425 WEST AMELIA EARHART DR. SE DECISION MADE: 10-JUL-03
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERHEART AED G3, MODEL 9300
CARDIAC SCIENCE 510(k) NO: K031987(SPECIAL)
ATTN: KENNETH OLSON PHONE NO : 952-939-2912
5474 FELTL RD. SE DECISION MADE: 30-JUL-03
MINNEAPOLIS, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFETY RELEASE ARCH BAR KIT
CASEY SURGICAL, LLC 510(k) NO: K031207(TRADITIONAL)
ATTN: JAMES E STANLEY PHONE NO : 816-347-9224
200 NE MULBERRY SE DECISION MADE: 15-JUL-03
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
LEE'S SUMMIT, MO 64086
DEVICE: CEFAR REHAB 2 AND REHAB 2 PRO
CEFAR MEDICAL AB 510(k) NO: K030403(TRADITIONAL)
ATTN: CONSTANCE G BUNDY PHONE NO : 763-571-1976
6740 RIVERVIEW TERRACE SE DECISION MADE: 17-JUL-03
MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BA
CENTERPULSE ORTHOPEDICS, INC. 510(k) NO: K031183(TRADITIONAL)
ATTN: ROBERT M WOLFARTH PHONE NO : 512-432-9324
9900 SPECTRUM DR. SE DECISION MADE: 14-JUL-03
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF; CLEARMEDICAL/WELCH AL
CLEAR MEDICAL, INC. 510(k) NO: K031416(TRADITIONAL)
ATTN: LANE ABENROTH PHONE NO : 425-401-1414
1776 136TH PL. NE SE DECISION MADE: 15-JUL-03
BELLEVUE, WA 98005 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR
CLINICAL DATA, INC. 510(k) NO: K031044(TRADITIONAL)
ATTN: WYNN STOCKING PHONE NO : 714-672-3553
1075 W. LAMBERT ROAD SE DECISION MADE: 15-JUL-03
BUILDING D 510(k) SUMMARY AVAILABLE FROM FDA
BREA, CA 92821
DEVICE: BRAIN COIL, MODEL 9900GE-64
CLINICAL MR SOLUTIONS, LLC 510(k) NO: K031536(TRADITIONAL)
ATTN: RALPH S HASHOIAN PHONE NO : 262-781-9394
3735 SHADYBROOK PLACE SE DECISION MADE: 18-JUL-03
BROOKFIELD, WI 53005 510(k) STATEMENT
DEVICE: LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS A
CLINIQA CORPORATION 510(k) NO: K031575(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900
1432 SOUTH MISSION RD. SE DECISION MADE: 23-JUL-03
FALLBROOK, CA 92028 510(k) STATEMENT
DEVICE: MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES
COALESCENT SURGICAL 510(k) NO: K031623(SPECIAL)
ATTN: MICHAEL A DANIEL PHONE NO : 415-407-0223
559 EAST WEDDELL DR. SE DECISION MADE: 03-JUL-03
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO HERMES O.R. CONTROL CENTER
COMPUTER MOTION, INC. 510(k) NO: K031720(SPECIAL)
ATTN: KEITH LOWREY PHONE NO : 805-685-3729
130 CREMONA DRIVE, SUITE B SE DECISION MADE: 11-JUL-03
GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO HERMES O.R. CONTROL CENTER
COMPUTER MOTION, INC. 510(k) NO: K031956(SPECIAL)
ATTN: KEITH LOWREY PHONE NO : 805-685-3729
130-B CREMONA DR. SE DECISION MADE: 17-JUL-03
GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONMED INTEGRATED SYSTEMS NURSES ASSISTANT
CONMED INTEGRATED SYSTEMS (CMIS) 510(k) NO: K031979(SPECIAL)
ATTN: C. JEFF LIPPS PHONE NO : 503-614-1106
1815 NW 169TH PLACE SE DECISION MADE: 25-JUL-03
SUITE 4020 510(k) SUMMARY AVAILABLE FROM FDA
BEAVERTON, OR 97006
DEVICE: FILMLESS CLINIC
CONNECT IMAGING, INC. 510(k) NO: K031704(ABBREVIATED)
ATTN: PHILIP J MANLY PHONE NO : 808-373-7048
850 WEST HIND DRIVE # 214 SE DECISION MADE: 31-JUL-03
HONOLULU, HI 96821 510(k) STATEMENT
DEVICE: COOK GASTRIC SIZING BALLOON CATHETER
COOK, INC. 510(k) NO: K030841(TRADITIONAL)
ATTN: CAROL ZWISSLER PHONE NO : 812-339-2235
750 DANIELS WAY SE DECISION MADE: 11-JUL-03
P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA
BLOOMINGTON, IN 47402-0489
DEVICE: MODIFICATION TO COOK ZILVER BILIARY STENT
COOK, INC. 510(k) NO: K031821(SPECIAL)
ATTN: CAROL ZWISSLER PHONE NO : 812-339-2235
750 DANIELS WAY SE DECISION MADE: 18-JUL-03
P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA
BLOOMINGTON, IN 47402-0489
DEVICE: CORIX 70 PLUS-USV
CORAMEX, S.A. 510(k) NO: K031802(TRADITIONAL)
ATTN: AL SOSA PHONE NO : 847-459-3889
251 E. DUNDEE ROAD SUITE #6 SE DECISION MADE: 21-JUL-03
WHEELING, IL 60090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIA
CORDIS CORP. 510(k) NO: K031777(SPECIAL)
ATTN: SAM MIRZA PHONE NO : 786-313-2007
14201 N.W. 60TH AVE. SE DECISION MADE: 07-JUL-03
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001
CORGENIX, INC. 510(k) NO: K031208(SPECIAL)
ATTN: NANCI DEXTER PHONE NO : 303-457-4345
12061 TEJON ST. SE DECISION MADE: 07-JUL-03
WESTMINSTER, CO 80234 510(k) STATEMENT
DEVICE: CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1M
CRYOMEDICAL INSTRUEMTS LTD. 510(k) NO: K031482(TRADITIONAL)
ATTN: GARETH COPPING PHONE NO : 44 162 3424200
CRYOMED HOUSE, GROVE WAY SE DECISION MADE: 10-JUL-03
MANSFIELD WOODHOUSE, NOTTS, UNITED510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYNOSURE PHOTOLIGHT PL
CYNOSURE, INC. 510(k) NO: K031258(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
10 ELIZABETH DR. SE DECISION MADE: 08-JUL-03
CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYNOSURE YAG FAMILY LASER (PHOTOGENICA YAG AND ACCLAIM)
CYNOSURE, INC. 510(k) NO: K031690(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
10 ELIZABETH DR. SE DECISION MADE: 08-JUL-03
CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMIT II PLUS COCAINE METABOLITE ASSAY
DADE BEHRING, INC. 510(k) NO: K031512(TRADITIONAL)
ATTN: KATHLEEN A DRAY-LYONS PHONE NO : 781-826-4551
P.O. BOX 6101 SE DECISION MADE: 23-JUL-03
NEWARK,, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANEL WITH NITROF
DADE BEHRING, INC. 510(k) NO: K031602(TRADITIONAL)
ATTN: ROBERT EUSEBIO PHONE NO : 916-374-3183
2040 ENTERPRISE BLVD. SE DECISION MADE: 31-JUL-03
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STAINLESS STEEL AQUATIC WHEELCHAIR
DB PERKS & ASSOCIATES LTD. 510(k) NO: K031910(TRADITIONAL)
ATTN: ED OLIVER PHONE NO : 425-557-9990
490 NW DATEWOOD DRIVE SE DECISION MADE: 25-JUL-03
ISSAQUAH, WA 98027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SLED CURING LIGHT SYSTEM
DENTSPLY INTERNATIONAL 510(k) NO: K031615(TRADITIONAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE. SE DECISION MADE: 21-JUL-03
YORK, PA 17405-0872 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESTYLUS ELECTRIC MOTOR SYSTEM
DENTSPLY INTL. 510(k) NO: K031145(TRADITIONAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE. SE DECISION MADE: 15-JUL-03
YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K031203(TRADITIONAL)
ATTN: DINA L WEISSMAN PHONE NO : 574-371-4905
700 ORTHOPAEDIC DR. SE DECISION MADE: 14-JUL-03
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: DEPUY CERAMIC FEMORAL HEADS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K031803(SPECIAL)
ATTN: KARLA A HAM PHONE NO : 574-371-4925
700 ORTHOPAEDIC DR. SE DECISION MADE: 01-JUL-03
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K031969(TRADITIONAL)
ATTN: KATHY K TRIER PHONE NO : 574-372-5039
700 ORTHOPAEDIC DR. SE DECISION MADE: 28-JUL-03
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: DIADEXUS PLAC TEST
DIADEXUS, INC. 510(k) NO: K030477(TRADITIONAL)
ATTN: ROBERT L WOLFERT PHONE NO : 650-246-6400
343 OYSTER POINT BLVD. SE DECISION MADE: 18-JUL-03
SOUTH SAN FRANCISCO, CA 94080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIF
DIDECO S.P.A. 510(k) NO: K032040(SPECIAL)
ATTN: BARRY SALL PHONE NO : 781-434-4742
195 WEST ST. SE DECISION MADE: 09-JUL-03
WALTHAM, MA 02451-1163 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FABIUS TIRO ANESTHESIA SYSTEM
DRAEGER MEDICAL, INC. 510(k) NO: K031400(SPECIAL)
ATTN: MICHAEL A KELHART PHONE NO : 215-721-5400
3135 QUARRY RD. SE DECISION MADE: 15-JUL-03
TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SITE-RITE IV ULTRASOUND SYSTEM
DYMAX CORP. 510(k) NO: K032135(TRADITIONAL)
ATTN: CHARLES MORREALE PHONE NO : 412-963-6884
271 KAPPA DR. SE DECISION MADE: 21-JUL-03
PITTSBURGH, PA 15238 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: EARLYDETECT MENOPAUSE TEST FOR FSH
EARLY DETECT, INC. 510(k) NO: K030058(TRADITIONAL)
ATTN: PETER GEORGE PHONE NO : 714-283-5190
2950 NORTH GLASSELL ST. SE DECISION MADE: 30-JUL-03
ORANGE, CA 92865 510(k) STATEMENT
DEVICE: EBI XFIX OPTIROM KNEE FIXATOR
EBI, L.P. 510(k) NO: K031093(TRADITIONAL)
ATTN: JON CAPAROTTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 10-JUL-03
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI SPINELINK - II SPINAL FIXATION SYSTEM
EBI, L.P. 510(k) NO: K031355(TRADITIONAL)
ATTN: FREDERIC TESTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 22-JUL-03
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI SPINELINK SPINAL FIXATION SYSTEM
EBI, L.P. 510(k) NO: K031424(TRADITIONAL)
ATTN: BARRY SANDS PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 22-JUL-03
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEROLET TOILET LIFT, MODEL AER-01
ECONOMIC HOLLAND B.V. 510(k) NO: K031045(TRADITIONAL)
ATTN: STEPHANIE WOLFKAMP PHONE NO : 336-766-7686
6785 FOREST OAK DR. SE DECISION MADE: 10-JUL-03
CLEMMONS, NC 27012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K024303(TRADITIONAL)
ATTN: KAVIN DRISKO PHONE NO : 949-250-2416
ONE EDWARDS WAY SE DECISION MADE: 03-JUL-03
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EKOS PERIPHERAL INFUSION SYSTEM
EKOS CORP. 510(k) NO: K030637(TRADITIONAL)
ATTN: JOCELYN KERSTEN PHONE NO : 425-482-1108
22030 20TH AVENUE S.E. SE DECISION MADE: 22-JUL-03
SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98021
DEVICE: CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION
ELECTROMED IMAGING INC. 510(k) NO: K031638(ABBREVIATED)
ATTN: WARREN BAKER PHONE NO : 450 681 3925
440 ARMAND-FRAPPIER BLVD.,#250 SE DECISION MADE: 21-JUL-03
LAVAL, QUEBEC, CANADA H7V 4B4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTROMEDICARIN 900
ELECTROMEDICARIN, S.A. 510(k) NO: K020478(ABBREVIATED)
ATTN: JAY MANSOUR PHONE NO : 678-908-8180
1308 MORNINGSIDE PARK DR. SE DECISION MADE: 17-JUL-03
ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM
ELEKTA INSTRUMENT AB 510(k) NO: K031980(SPECIAL)
ATTN: PETER LOWENDAHL PHONE NO : 46 8 58725400
BIRGER JARLSGATAN 53 SE DECISION MADE: 25-JUL-03
PO BOX 7593 510(k) STATEMENT
STOCKHOLM, SWEDEN SE-103 93
DEVICE: ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT
ELEKTA INSTRUMENT AB 510(k) NO: K031999(SPECIAL)
ATTN: PETER LOWENDAHL PHONE NO : 46 8 58725400
BIRGER JARLSGATAN 53 SE DECISION MADE: 25-JUL-03
STOCKHOLM, SWEDEN S-103 93 510(k) STATEMENT
DEVICE: CARDIOVATIONS OPTICAL BIPOLAR DEVICE
ETHICON, INC. 510(k) NO: K031846(SPECIAL)
ATTN: PETER CECCHINI PHONE NO : 908-218-2457
ROUTE 22 WEST SE DECISION MADE: 21-JUL-03
SOMERVILLE, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOVATIONS RETRACTOR
ETHICON, INC. 510(k) NO: K031847(SPECIAL)
ATTN: PETER CECCHINI PHONE NO : 908-218-2457
ROUTE 22 WEST SE DECISION MADE: 21-JUL-03
SOMERVILLE, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LORDEX POWER TRACTION EQUIPMENT
EVER PROSPEROUS INSTRUMENT INC 510(k) NO: K031227(TRADITIONAL)
ATTN: JOHN BOREN PHONE NO : 281-398-1700
15915 KATY FREEWAY SE DECISION MADE: 17-JUL-03
SUITE 645 510(k) STATEMENT
HOUSTON, TX 77094
DEVICE: EXCEL PRIMARY SOLUTION SET
EXELINT INTL. CO. 510(k) NO: K031500(TRADITIONAL)
ATTN: ARMAND HAMID PHONE NO : 310-649-0707
5840 WEST CENTINELA AVE. SE DECISION MADE: 25-JUL-03
LOS ANGELES, CA 90045 510(k) STATEMENT
DEVICE: FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS
FIRST QUALITY HYGIENIC, INC. 510(k) NO: K031067(TRADITIONAL)
ATTN: ROBERT J STAAB PHONE NO : 201-327-0035
73 FRANKLIN TURNPIKE SE DECISION MADE: 14-JUL-03
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESPIRATORY HUMIDIFIER, MODEL MR850
FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K020332(TRADITIONAL)
ATTN: BRETT WHISTON PHONE NO : 649 574 0100
15 MAURICE PAYKEL PLACE SE DECISION MADE: 07-JUL-03
EAST TAMAKI, NEW ZEALAND 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NATURALASE LP ND:YAG LASER
FOCUS MEDICAL, LLC. 510(k) NO: K031828(TRADITIONAL)
ATTN: JOHN LEE, JR PHONE NO : 203-730-8885
23 FRANCIS J. CLARKE CIRCLE SE DECISION MADE: 17-JUL-03
BETHEL, CT 06801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOTONA FIDELIS PLUS ND:YAG LASER SYSTEM
FOTONA D.D. 510(k) NO: K024204(TRADITIONAL)
ATTN: MOJCA VALJAVEC PHONE NO : 386 1 5009114
STEGNE 7, SE DECISION MADE: 07-JUL-03
LJUBLJANA, SLOVENIA 1210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GALT MEDICAL GUIDEWIRE
GALT MEDICAL CORP. 510(k) NO: K031916(SPECIAL)
ATTN: DAVID CATLIN PHONE NO : 972-271-5177
2475 MERRITT DR. SE DECISION MADE: 17-JUL-03
GARLAND, TX 75041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DPX SERIES BRAVO DUO BONE DENSITOMETER
GE LUNAR CORP. 510(k) NO: K030962(TRADITIONAL)
ATTN: JAMES P RASKOB PHONE NO : 608-826-7425
726 HEARTLAND TRAIL SE DECISION MADE: 25-JUL-03
MADISON, WI 53717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE DELTA SOFTWARE OPTION FOR MRI
GE MEDICAL SYSTEMS 510(k) NO: K031927(TRADITIONAL)
ATTN: LARRY KREGER PHONE NO : 262-544-3464
3200 N. GRANDVIEW BLVD. SE DECISION MADE: 02-JUL-03
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: 8 CHANNEL CARDIAC PHASED ARRAY COIL
GE MEDICAL SYSTEMS 510(k) NO: K032045(SPECIAL)
ATTN: LARRY KROGER PHONE NO : 262-544-3894
P.O. BOX 414 SE DECISION MADE: 30-JUL-03
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K031376(SPECIAL)
ATTN: MELISSA ROBINSON PHONE NO : 817-887-2133
4502 WOODLAND CORP.BLVD. SE DECISION MADE: 16-JUL-03
TAMPA, FL 33614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07,
GEBAUER CO. 510(k) NO: K031036(TRADITIONAL)
ATTN: AMY J PAUKOVITS PHONE NO : 216-271-5252
9410 ST. CATHERINE AVE. SE DECISION MADE: 10-JUL-03
CLEVELAND, OH 44104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE LOGIQ 7, MODEL 2354858
GENERAL ELECTRIC CO. 510(k) NO: K032182(SPECIAL)
ATTN: ALLEN SCHUH PHONE NO : 414-647-4385
P.O. BOX 414 SE DECISION MADE: 25-JUL-03
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUS
GENZYME BIOSURGERY 510(k) NO: K031554(TRADITIONAL)
ATTN: DENISE LIMA PHONE NO : 508-677-6439
600 AIRPORT RD. SE DECISION MADE: 25-JUL-03
FALL RIVER, MA 02720-4740 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
GETINGE USA, INC 510(k) NO: K031647(TRADITIONAL)
ATTN: KARLA BYRNE PHONE NO : 585-272-5007
1777 EAST HENRIETTA RD. SE DECISION MADE: 29-JUL-03
ROCHESTER, NY 14623-3133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GIVEN DIAGNOSTIC SYSTEM
GIVEN IMAGING LTD. 510(k) NO: K031033(TRADITIONAL)
ATTN: SHOSHANA FRIEDMAN PHONE NO : 972 490 97784
NEW INDUSTRIAL PARK SE DECISION MADE: 01-JUL-03
P.O. BOX 258 510(k) SUMMARY AVAILABLE FROM FDA
YOQNEAM, ISRAEL 20692
DEVICE: NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE
GREEN PROSPECT SDN BHD 510(k) NO: K031580(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 25-JUL-03
SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STERILE POWDER FREE, LATEX EXAMINATION GLOVES, POLYMER COATE
GREEN PROSPECT SDN BHD 510(k) NO: K031581(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 24-JUL-03
SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE
GUARDIAN ANGEL PRODUCTS, INC. 510(k) NO: K030547(SPECIAL)
ATTN: ERNEST H PESCATORE PHONE NO : 215-938-7677
2771 PHILMONT AVE. SE DECISION MADE: 11-JUL-03
HUNTINGDON VALLEY, PA 19006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPIDO CUT-AWAY CUTTER
GUIDANT CORP. 510(k) NO: K031459(TRADITIONAL)
ATTN: SHAH HILALI PHONE NO : 651-582-7752
4100 HAMLINE AVE., NORTH SE DECISION MADE: 23-JUL-03
ST. PAUL, MN 55112-5798 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE
GUIDANT CORPORATION 510(k) NO: K031688(SPECIAL)
ATTN: STEPHANIE ISGRIGG ROBINSON PHONE NO : 651-582-4927
4100 HAMLINE AVE NORTH SE DECISION MADE: 02-JUL-03
ST PAUL, MN 55112-5798 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES)
GYRUS MEDICAL, INC. 510(k) NO: K031085(TRADITIONAL)
ATTN: MERCEDES BAYANI PHONE NO : 763-416-3015
6655 WEDGWOOD RD. SE DECISION MADE: 21-JUL-03
SUITE 105 510(k) SUMMARY AVAILABLE FROM FDA
MAPLE GROVE, MN 55311-3602
DEVICE: HL168R
HEALTH & LIFE CO., LTD. 510(k) NO: K031695(SPECIAL)
ATTN: SUSAN CHEN PHONE NO : 886 282 271300
9F, NO.186, JIAN YI ROAD SE DECISION MADE: 01-JUL-03
CHUNG HO CITY, TAIPEI, HSIEN, CHIN510(k) STATEMENT
DEVICE: HL888RA
HEALTH & LIFE CO., LTD. 510(k) NO: K031835(SPECIAL)
ATTN: SUSAN CHEN PHONE NO : 886 282 271300
9F, NO.186, JIAN YI ROAD SE DECISION MADE: 01-JUL-03
CHUNG HO CITY, TAIPEI, HSIEN, CHIN510(k) STATEMENT
DEVICE: SUILE WOUND DRESSING
HEDONIST BIOCHEMICAL TECHNOLOGIES 510(k) NO: K022967(TRADITIONAL)
ATTN: ERIC LUO PHONE NO : 972-491-2059
6833 SAINT LAWRENCE ST. SE DECISION MADE: 08-JUL-03
PLANO, TX 75024 510(k) STATEMENT
DEVICE: HOFFRICHTER VECTOR, VECTOR PLUS, VECTOR BI-VEVEL, VECTOR BI-LEVE
HOFFRICHTER GMBH 510(k) NO: K014074(TRADITIONAL)
ATTN: STEPHEN H GORSKI PHONE NO : 262-594-2114
S65 W35739 PIPER RD. SE DECISION MADE: 23-JUL-03
EAGLE, WI 53119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART
HOME DIAGNOSTICS, INC. 510(k) NO: K030703(TRADITIONAL)
ATTN: KAREN DEVINCENT PHONE NO : 954-677-9201
2400 N.W. 55TH CT. SE DECISION MADE: 11-JUL-03
FORT LAUDERDALE, FL 33309 510(k) STATEMENT
DEVICE: LIFEVALVE CENTRAL VENOUS CATHTER
HORIZON MEDICAL PRODUCTS, INC. 510(k) NO: K031718(SPECIAL)
ATTN: SCOTT MOELLER PHONE NO : 800-472-5221
1 HORIZON WAY SE DECISION MADE: 02-JUL-03
MANCHESTER, GA 31816 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPO
HOWMEDICA OSTEONICS CORP. 510(k) NO: K031480(TRADITIONAL)
ATTN: MARGARET F CROWE PHONE NO : 201-831-5580
59 ROUTE 17 SOUTH SE DECISION MADE: 31-JUL-03
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XIA SPINAL SYSTEM AND XIA STAINLESS STEEL SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K031893(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718
59 ROUTE 17 SE DECISION MADE: 17-JUL-03
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOFFMANN II COMPACT BALTIMORE COUPLING
HOWMEDICA OSTEONICS CORP. 510(k) NO: K031941(SPECIAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581
59 ROUTE 17 SE DECISION MADE: 24-JUL-03
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER PLATING SYSTEM PERIARTICULAR PLATES
HOWMEDICA OSTEONICS CORP. 510(k) NO: K031959(SPECIAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581
59 ROUTE 17 SOUTH SE DECISION MADE: 25-JUL-03
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL 780
HUDSON RESPIRATORY CARE, INC. 510(k) NO: K031383(SPECIAL)
ATTN: CHARLES MIERKIEWICZ PHONE NO : 909-676-5611
27711 DIAZ RD. SE DECISION MADE: 07-JUL-03
P.O. BOX 9020 510(k) SUMMARY AVAILABLE FROM FDA
TEMECULA, CA 92589-9020
DEVICE: ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS
ICS MEDICAL 510(k) NO: K031986(SPECIAL)
ATTN: DELMAR F BLOEM PHONE NO : 800-289-2150
125 COMMERCE DR. SE DECISION MADE: 24-JUL-03
SCHAUMBURG, IL 60173-5329 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS
IMAGE ANALYSIS, INC. 510(k) NO: K031991(SPECIAL)
ATTN: BEN ARNOLD PHONE NO : 270-384-6400
1380 BURKESVILLE ST. SE DECISION MADE: 30-JUL-03
COLUMBIA, KY 42728 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RUBELLACOL
IMMUNOSTICS, INC. 510(k) NO: K031490(TRADITIONAL)
ATTN: JEFFREY FLEISHMAN PHONE NO : 732-918-0770
3505 SUNSET AVE. SE DECISION MADE: 16-JUL-03
OCEAN, NJ 07712 510(k) STATEMENT
DEVICE: OSSEOTITE NT CERTAIN IMPLANTS
IMPLANT INNOVATIONS, INC. 510(k) NO: K031475(TRADITIONAL)
ATTN: JACQUELYN A HUGHES PHONE NO : 561-776-6819
4555 RIVERSIDE DR. SE DECISION MADE: 28-JUL-03
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1
IMPLEX CORP. 510(k) NO: K031823(SPECIAL)
ATTN: MARCI HALEVI PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 11-JUL-03
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOSIL FACTOR IX DEFICIENT PLASMA
INSTRUMENTATION LABORATORY CO. 510(k) NO: K031829(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
526 RT. 303 SE DECISION MADE: 31-JUL-03
ORANGEBURG, NY 10962 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTION JET AJ-4270 URINE ANALYZER
INTERNATIONAL REMOTE IMAGING SYSTE510(k) NO: K030600(TRADITIONAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 11-JUL-03
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN1
INTRALUMINAL THERAPEUTICS, INC. 510(k) NO: K031417(TRADITIONAL)
ATTN: PAMELA MISAJON PHONE NO : 760-918-1820
6354 CORTE DEL ABETO SE DECISION MADE: 11-JUL-03
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92009
DEVICE: SAFE-CONNECT DRUG DISPENSING SPIKE, MODELS SC 4020, SC 4015, SC
INTRAVASCULAR INCORPORATED 510(k) NO: K031783(SPECIAL)
ATTN: STEVE APERAVICH PHONE NO : 847-596-7700
3600 BUR WOOD DR. SE DECISION MADE: 01-JUL-03
WAUKEGAN, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RH-900
IOMED, INC. 510(k) NO: K031115(TRADITIONAL)
ATTN: CURTIS JENSEN PHONE NO : 801-975-1191
2441 SOUTH 3850 WEST, SUITE A SE DECISION MADE: 10-JUL-03
SALT LAKE CITY, UT 84120-9941 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96
IVD RESEARCH, INC. 510(k) NO: K031059(TRADITIONAL)
ATTN: DAVE LAMBILLOTTE PHONE NO : 760-929-7744
5909 SEA LION PLACE, SUITE D SE DECISION MADE: 10-JUL-03
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: JASON MARINE ALL TERRAIN ELECTRIC WHEELCHAIR, MODEL SEEKER II
JASON MARINE ENTERPRISES, INC. 510(k) NO: K031342(ABBREVIATED)
ATTN: BRIAN GAGNON PHONE NO : 888-773-3537
4311 N.W. 64TH AVE. SE DECISION MADE: 10-JUL-03
CORAL SPRINGS, FL 33067 510(k) STATEMENT
DEVICE: JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT), PL
JMS NORTH AMERICA CORP. 510(k) NO: K023668(TRADITIONAL)
ATTN: SWEE CHEAU CHONG PHONE NO : 510-888-9090
22320 FOOTHILL BLVD., SE DECISION MADE: 01-JUL-03
SUITE 350 510(k) STATEMENT
HAYWARD, CA 94541
DEVICE: TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1
KALACO SCIENTIFIC, INC. 510(k) NO: K024377(TRADITIONAL)
ATTN: GRACE BARTOO PHONE NO : 650-654-4484
131 GLENN WAY SE DECISION MADE: 21-JUL-03
SUITE 7 510(k) SUMMARY AVAILABLE FROM FDA
SAN CARLOS, CA 94070
DEVICE: PROPHYPEARLS
KAVO AMERICA 510(k) NO: K031868(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 09-JUL-03
DEER FIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60
KAVO AMERICA 510(k) NO: K032081(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 24-JUL-03
DEER FIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STAND OUT
KERR CORP. 510(k) NO: K031484(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 716-516-7484
1717 WEST COLLINS AVE. SE DECISION MADE: 03-JUL-03
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTIBOND FL
KERR DENTAL MATERIALS CENTER 510(k) NO: K031444(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVE. SE DECISION MADE: 02-JUL-03
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX
KOVEN TECHNOLOGY, INC. 510(k) NO: K031504(TRADITIONAL)
ATTN: J. HARVEY KNAUSS PHONE NO : 832-285-9423
11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 18-JUL-03
HOUSTON, TX 77071-3404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KUANN DAH, COOL TANK MOTORIZED SCOOTER, KS4L320
KUANN DAH INDUSTRY CO., LTD. 510(k) NO: K031309(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58 FU-CHIUN ST. SE DECISION MADE: 31-JUL-03
HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES
LHASA MEDICAL, INC. 510(k) NO: K031060(TRADITIONAL)
ATTN: KYUNG P RIIHIMAKI PHONE NO : 781-335-5288
234 LIBBEY PKWY. SE DECISION MADE: 11-JUL-03
WEYMOUTH, MA 02189 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DBC PRESS ACUPUNCTURE NEEDLES
LHASA MEDICAL, INC. 510(k) NO: K031250(TRADITIONAL)
ATTN: KYUNG P RIIHIMAKI PHONE NO : 781-340-1637
234 LIBBEY PKWY. SE DECISION MADE: 15-JUL-03
WEYMOUTH, MA 02189 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445
LINVATEC BIOMATERIALS, LTD. 510(k) NO: K031981(SPECIAL)
ATTN: LAURA KREJCI PHONE NO : 727-399-5234
1311 CONCEPT BLVD SE DECISION MADE: 25-JUL-03
LARGO, FL 33773 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUMENIS FAMILY OF DISPOSABLE CONTACT TIP DELIVERY DEVICES
LUMENIS, LTD. 510(k) NO: K030033(TRADITIONAL)
ATTN: ANNE WORDEN PHONE NO : 925-895-1200
2400 CONDENSA ST. SE DECISION MADE: 21-JUL-03
SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS
LUMENIS, LTD. 510(k) NO: K030342(TRADITIONAL)
ATTN: ANDREA L RUTH PHONE NO : 408-764-3235
2400 CONDENSA ST. SE DECISION MADE: 17-JUL-03
SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MACROPORE OS RECONSTRUCTION
MACROPORE BIOSURGERY, INC. 510(k) NO: K024169(TRADITIONAL)
ATTN: KENNETH K KLEINHENZ PHONE NO : 858-458-0900
6740 TOP GUN ST. SE DECISION MADE: 01-JUL-03
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAINLINE MAXIE HCG URINE PREGNANCY TEST
MAINLINE TECHNOLOGY, INC. 510(k) NO: K031445(TRADITIONAL)
ATTN: MARTHA MAZUREK PHONE NO : 734-930-2043
3985 RESEARCH PARK DR. SE DECISION MADE: 01-JUL-03
ANN ARBOR, MI 48108 510(k) STATEMENT
DEVICE: OPTIBOLUS
MALLINCKRODT INC., LIEBEL-FLARSHEI510(k) NO: K031339(SPECIAL)
ATTN: ELLIS ROGERS PHONE NO : 513-948-4041
2111 EAST GALBRAITH RD. SE DECISION MADE: 11-JUL-03
CINCINNATI, OH 45237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERSONAL DIGITAL WORKSTATION (PDW); FILM DIGITIZING CAMERA AND D
MAXXVISION, LLC 510(k) NO: K031372(TRADITIONAL)
ATTN: JAMES K WALKER PHONE NO : 352-378-6620
3014 NE 21ST WAY SE DECISION MADE: 02-JUL-03
GAINESVILLE, FL 32609 510(k) STATEMENT
DEVICE: MAYO CLINIC BC-10 1.5T
MAYO MEDICAL VENTURES 510(k) NO: K031119(ABBREVIATED)
ATTN: JADE SADOSTY PHONE NO : 507-284-8878
200 FIRST ST SW SE DECISION MADE: 15-JUL-03
ROCHESTER, MN 55905 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL
MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K031392(TRADITIONAL)
ATTN: PENNY M LAYMAN PHONE NO : 805-987-7891
5300 ADOLFO RD. SE DECISION MADE: 01-JUL-03
CAMARILLO, CA 93012 510(k) STATEMENT
DEVICE: URICHEMTRAK LIQUID ASSAYED URINE CONTROL
MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K031441(TRADITIONAL)
ATTN: PENNY M LAYMAN PHONE NO : 805-987-7891
5300 ADOLFO RD. SE DECISION MADE: 01-JUL-03
CAMARILLO, CA 93012 510(k) STATEMENT
DEVICE: MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL
MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K031890(TRADITIONAL)
ATTN: PENNY M LAYMAN PHONE NO : 805-987-7891
5300 ADOLFO RD. SE DECISION MADE: 16-JUL-03
CAMARILLO, CA 93012 510(k) STATEMENT
DEVICE: NGT
MEDICAL INNOVATIVE PRODUCTS 510(k) NO: K022558(TRADITIONAL)
ATTN: DEBBIE IAMPIETRO PHONE NO : 508-259-7374
7 TIFFANY TRAIL SE DECISION MADE: 08-JUL-03
HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIX2VIAL TRANSFER DEVICE
MEDIMOP MEDICAL PROJECTS, LTD. 510(k) NO: K031861(TRADITIONAL)
ATTN: BENNY ARAZY PHONE NO : 972 499 40337
MITZPE AVIV, INDUSTRIAL PK 13 SE DECISION MADE: 29-JUL-03
M.P. MISGAV, ISRAEL 20187 510(k) STATEMENT
DEVICE: SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMEN
MEDISISS 510(k) NO: K030919(TRADITIONAL)
ATTN: MRRY ANN BARKER PHONE NO : 541-549-4164
723 CURTIS COURT SE DECISION MADE: 03-JUL-03
PO BOX 2060 510(k) SUMMARY AVAILABLE FROM FDA
SISTERS, OR 97759 THIRD PARTY REVIEW
DEVICE: MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
MEDLINE INDUSTRIES, INC. 510(k) NO: K031843(SPECIAL)
ATTN: ANDREA HAFERKAMP PHONE NO : 847-837-2759
ONE MEDLINE PL. SE DECISION MADE: 03-JUL-03
MUNDELEIN, IL 60060-4486 510(k) STATEMENT
DEVICE: MEDRAD SWABBABLE VALVE TRANSFER SET
MEDRAD, INC. 510(k) NO: K031808(SPECIAL)
ATTN: ANDREW P ZELTWANGER PHONE NO : 412-767-2400
ONE MEDRAD DR. SE DECISION MADE: 11-JUL-03
INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERDICT II, PROFILE II
MEDTOX DIAGNOSTICS, INC. 510(k) NO: K031032(SPECIAL)
ATTN: ALAN MORRIS PHONE NO : 336-226-6311
1238 ANTHONY RD. SE DECISION MADE: 14-JUL-03
BURLINGTON, NC 27215 510(k) STATEMENT
DEVICE: MC2X MULTI-STAGE VENOUS CANNULA
MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K031776(SPECIAL)
ATTN: RONALD W BENNETT PHONE NO : 763-391-9086
7611 NORTHLAND DR. SE DECISION MADE: 25-JUL-03
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX
MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K031827(SPECIAL)
ATTN: PREETI JAIN PHONE NO : 763-391-9000
7611 NORTHLAND DR. SE DECISION MADE: 02-JUL-03
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERTE-STACK SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K031780(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 30-JUL-03
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIOC 7F LAUNCHER BIOPSY GUIDE CATHETER, MODEL LA7RVBB, MED
MEDTRONIC, INC. 510(k) NO: K030671(TRADITIONAL)
ATTN: FRED L BOUCHER PHONE NO : 978-777-0042
37A CHERRY HILL DR. SE DECISION MADE: 31-JUL-03
DANVERS, MA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH
MEDTRONIC, INC. 510(k) NO: K031211(TRADITIONAL)
ATTN: LYNN JENSEN PHONE NO : 763-514-4459
7000 CENTRAL AVENUE NE SE DECISION MADE: 17-JUL-03
MINNEAPOLIS, MN 55432-3576 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM
MEDTRONIC, INC. 510(k) NO: K031247(TRADITIONAL)
ATTN: SCOTT CUNDY PHONE NO : 763-391-9941
7601 NORTHLAND DR. SE DECISION MADE: 17-JUL-03
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEGATECH SCIENTIFIC FACE MASK
MEGATECH SCIENTIFIC PTE LTD 510(k) NO: K030239(TRADITIONAL)
ATTN: CHIAM KIA CHEE PHONE NO : 65 656 57211
BLK 2 BUKIT BATOK STREET 24 SE DECISION MADE: 24-JUL-03
SKYTECH #09-03, SINGAPORE 659480 510(k) STATEMENT
DEVICE: MENTOR OBTAPE TRANS-OBTURATOR TAPE
MENTOR CORP. 510(k) NO: K031767(TRADITIONAL)
ATTN: DONNA CRAWFORD PHONE NO : 805-879-6304
201 MENTOR DR. SE DECISION MADE: 17-JUL-03
SANTA BARBARA, CA 93111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINI STATCO2 CO2 DETECTOR, MODEL 10-55371
MERCURY MEDICAL 510(k) NO: K031411(TRADITIONAL)
ATTN: WAYNE GLOVER PHONE NO : 800-237-6418
11300 49TH ST. NORTH SE DECISION MADE: 30-JUL-03
CLEARWATER, FL 33762-4800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAPPHIRE DETACHABLE COIL SYSTEM
MICRO THERAPEUTICS, INC. 510(k) NO: K030392(TRADITIONAL)
ATTN: FLORIN TRUUVERT PHONE NO : 949-837-3700
2 GOODYEAR SE DECISION MADE: 21-JUL-03
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PCW PERCUTANEOUS COMPRESSION WIRE
MILLENNIUM MEDICAL TECHNOLOGIES, I510(k) NO: K031050(TRADITIONAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LN. SE DECISION MADE: 14-JUL-03
SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANT HILL, CA 94523-3389
DEVICE: MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712
MINIMED, INC. 510(k) NO: K031390(TRADITIONAL)
ATTN: MIRIELLE MENGOTTO PHONE NO : 818-362-5958
18000 DEVONSHIRE ST. SE DECISION MADE: 23-JUL-03
NORTHRIDGE, CA 91325 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 4 FRENCH & 5 FRENCH ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS MODEL
MOGUL ENTERPRISES 510(k) NO: K030852(SPECIAL)
ATTN: JAMIL MOGUL PHONE NO : 408-629-3340
6387 SAN IGNACIO AVE. SE DECISION MADE: 10-JUL-03
SAN JOSE, CA 95119 510(k) STATEMENT
DEVICE: ELI 200+ AUDICOR
MORTARA INSTRUMENT, INC. 510(k) NO: K031182(TRADITIONAL)
ATTN: HARLAN L VAN MATRE PHONE NO : 414-354-1600
7865 NORTH 86TH ST. SE DECISION MADE: 25-JUL-03
MILWAUKEE, WI 53224 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODEL J-5 MVO-MONITOR
MYOTRONICS-NOROMED, INC. 510(k) NO: K031998(SPECIAL)
ATTN: FRAY ADIB PHONE NO : 206-243-4214
15425 53RD AVE. SOUTH SE DECISION MADE: 24-JUL-03
TUKWILA, WA 98188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MYTECH / HAPPY LIFE BLOOD PRESSURE MONITOR
MYTECH TECHNOLOGY CO., LTD. 510(k) NO: K030221(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 25-JUL-03
HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 400
NEEDLETECH PRODUCTS, INC. 510(k) NO: K031173(TRADITIONAL)
ATTN: RICK TRIPP PHONE NO : 508-431-4000
81 WEST ST. SE DECISION MADE: 23-JUL-03
ATTLEBORO, MA 02703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NICHOLS ADVANTAGE ALDOSTERONE ASSAY
NICHOLS INSTITUTE DIAGNOSTICS 510(k) NO: K032188(TRADITIONAL)
ATTN: JIMMY WONG PHONE NO : 949-940-7260
1311 CALLE BATIDO SE DECISION MADE: 31-JUL-03
SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CARBON FIBER BRIDGE, MODEL 28757
NOBEL BIOCARE AB 510(k) NO: K031070(TRADITIONAL)
ATTN: ELIZABETH J MASON PHONE NO : 714-282-4800
22725 SAVI RANCH PKWY. SE DECISION MADE: 03-JUL-03
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESTHETIC ZIRCONIA ABUTMENT
NOBEL BIOCARE AB 510(k) NO: K031719(SPECIAL)
ATTN: ELIZABETH J MASON PHONE NO : 714-282-4800
22715 SAVI RANCH PKWY. SE DECISION MADE: 02-JUL-03
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOBEL DIRECT, MODELS 30937, 30938
NOBEL BIOCARE USA, INC. 510(k) NO: K031345(TRADITIONAL)
ATTN: ELIZABETH J MASON PHONE NO : 714-282-4800
22715 SAVI RANCH PKWY. SE DECISION MADE: 24-JUL-03
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL 9600, AVANT PULSE OXIMETER
NONIN MEDICAL, INC. 510(k) NO: K023044(TRADITIONAL)
ATTN: RICHARD P BENNETT PHONE NO : 763-577-3166
2605 FERNBROOK LN. NORTH SE DECISION MADE: 23-JUL-03
PLYMOUTH, MN 55447-4755 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROVIDENCE MOLDING HELMET
NORTHEAST ORTHOTICS AND PROTHETICS510(k) NO: K030669(ABBREVIATED)
ATTN: D. BARRY MCCOY PHONE NO : 401-444-5477
170 MACKLIN STREET SE DECISION MADE: 18-JUL-03
CRANSTON, RI 02920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NXSTAGE SYSTEM ONE
NXSTAGE MEDICAL, INC. 510(k) NO: K030470(TRADITIONAL)
ATTN: NORMA LEMAY PHONE NO : 978-687-4700
439 SOUTH UNION ST. SE DECISION MADE: 07-JUL-03
SUITE 501 510(k) SUMMARY AVAILABLE FROM FDA
LAWRENCE, MA 01843 THIRD PARTY REVIEW
DEVICE: HYDROGENICS 2.0 60 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) C
OCULAR SCIENCES, INC. 510(k) NO: K031477(ABBREVIATED)
ATTN: RICHARD E LIPPMAN PHONE NO : 240-683-3738
15825 SHADY GROVE RD, SUITE 30 SE DECISION MADE: 18-JUL-03
ROCKVILLE, MD 20850 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
OLYMPUS OPTICAL CO., LTD. 510(k) NO: K031648(TRADITIONAL)
ATTN: TINA STEFFANIE-OAK PHONE NO : 631-844-5477
TWO CORPORATE CENTER DR. SE DECISION MADE: 24-JUL-03
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE
OLYMPUS OPTICAL CO., LTD. 510(k) NO: K032092(TRADITIONAL)
ATTN: MASAO WADA PHONE NO : 814 264 22891
34-3 HIRAI HINODE-MACHI, SE DECISION MADE: 16-JUL-03
NISHITAMA-GUN, TOKYO, JAPAN 190-01510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE
OLYMPUS OPTO-ELECTRONICS CO., LTD.510(k) NO: K031256(TRADITIONAL)
ATTN: TINA STEFFANIE-OAK PHONE NO : 631-844-5477
TWO CORPORATE CENTER DR. SE DECISION MADE: 23-JUL-03
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500
OPUS MEDICAL, INC. 510(k) NO: K030170(TRADITIONAL)
ATTN: JAMES W HART PHONE NO : 949-234-0400
27127 CALLE ARROYO, SUITE 1924 SE DECISION MADE: 28-JUL-03
SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)
ORGAN RECOVERY SYSTEMS, INC. 510(k) NO: K021362(TRADITIONAL)
ATTN: STANLEY J HARRIS PHONE NO : 843-722-6657
701 EAST BAY ST. SE DECISION MADE: 31-JUL-03
SUITE 433 510(k) STATEMENT
CHARLESTON, SC 29403
DEVICE: ORTHO DEVELOPMENT BALANCED KNEE MODULAR TIBIAL SYSTEM
ORTHO DEVELOPMENT CORP. 510(k) NO: K031201(TRADITIONAL)
ATTN: NADEEM AHMED PHONE NO : 801-553-9991
12187 SOUTH BUSINESS PARK DR. SE DECISION MADE: 15-JUL-03
DRAPER, UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXTENDERS BGS GRANULES, CUBES, BLOCKS, AND PLUGS
OSTEOBIOLOGICS, INC. 510(k) NO: K030288(TRADITIONAL)
ATTN: GABRIELE G NEIDERAUER PHONE NO : 210-690-2131
UNIVERSITY BUSINESS PARK SE DECISION MADE: 17-JUL-03
12500 NETWORK, SUITE 112 510(k) SUMMARY AVAILABLE FROM FDA
SAN ANTONIO, TX 78249-3308
DEVICE: TEMPORARY RESIN CEMENT
PARKELL, INC. 510(k) NO: K031212(TRADITIONAL)
ATTN: NELSON J GENDUSA PHONE NO : 631-249-1134
155 SCHMITT BLVD. SE DECISION MADE: 11-JUL-03
P.O. BOX 376 510(k) SUMMARY AVAILABLE FROM FDA
FARMINGDALE, NY 11735
DEVICE: PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN
PASCO LABORATORIES, INC. 510(k) NO: K031727(TRADITIONAL)
ATTN: LINDA K DILLON PHONE NO : 303-390-3240
12750 WEST 42ND AVE. SE DECISION MADE: 30-JUL-03
WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHOCKWAVE SUSPENSION WHEELCHAIR
PER4MAX MEDICAL, LLC 510(k) NO: K032123(TRADITIONAL)
ATTN: TIM CRISWELL PHONE NO : 972-641-6773
2550 114TH ST., SUITE 190 SE DECISION MADE: 31-JUL-03
GRAND PRAIRIE, TX 75050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SECQUIRE CELL SEPARATOR
PERFUSION PARTNERS & ASSOC. INC. 510(k) NO: K024080(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 888-729-9674
P.O. BOX 4341 SE DECISION MADE: 02-JUL-03
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM SOFTWARE
PHILIPS MEDICAL SYSTEMS 510(k) NO: K030939(SPECIAL)
ATTN: JUDITH K PHILLIPS PHONE NO : 412-279-3263
1082 BOWER HILL RD. SE DECISION MADE: 15-JUL-03
PITTSBURGH, PA 15243 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PICOSAT II SPO2 PULSE OXIMETRY MODULE
PHILIPS MEDICAL SYSTEMS 510(k) NO: K030973(SPECIAL)
ATTN: DAVID OSBORN PHONE NO : 978-659-3178
3000 MINUTEMAN RD. SE DECISION MADE: 23-JUL-03
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III
PHILIPS MEDICAL SYSTEMS 510(k) NO: K031422(ABBREVIATED)
ATTN: SONGHUA ZHANG PHONE NO : 978-659-7319
3000 MINUTEMAN RD. SE DECISION MADE: 03-JUL-03
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PHILIPS VIEWFORUM 2003
PHILIPS MEDICAL SYSTEMS 510(k) NO: K032096(TRADITIONAL)
ATTN: LYNN T HARMER PHONE NO : 425-487-7312
22100 BOTHELL EVERETT HWY SE DECISION MADE: 18-JUL-03
P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98041-8431 THIRD PARTY REVIEW
DEVICE: PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M51
PHILIPS MEDICAL SYSTEMS 510(k) NO: K032103(SPECIAL)
ATTN: SONGHUA ZHANG PHONE NO : 978-659-7319
3000 MINUTEMAN RD. SE DECISION MADE: 22-JUL-03
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUNLEE "FORMAT" COLLIMATOR FAMILY
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K031597(TRADITIONAL)
ATTN: LYNN HARMER PHONE NO : 425-487-7312
22100 BOTHELL EVERETT HWY. SE DECISION MADE: 21-JUL-03
P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98041-3003
DEVICE: PHILLIPS OMNIDIAGNOST ELEVA
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K032046(TRADITIONAL)
ATTN: LYNN HARMER PHONE NO : 425-487-7312
22100 BOTHELL EVERETT HWY. SE DECISION MADE: 17-JUL-03
P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98041-3003 THIRD PARTY REVIEW
DEVICE: GEMINI 16
PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K032036(TRADITIONAL)
ATTN: CHRISTOF LITTWITZ PHONE NO : 440-483-3585
595 MINER RD. SE DECISION MADE: 11-JUL-03
CLEVELAND, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: OMNILUX RED
PHOTO THERAPEUTICS LIMITED 510(k) NO: K030426(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245
5 TIMBER LN. SE DECISION MADE: 17-JUL-03
NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UC-PLUS SOLUTION UNICONDYLAR KNEE
PLUS ORTHOPEDICS 510(k) NO: K032052(SPECIAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 25-JUL-03
ROUND ROCK, TX 78681-2700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER
PNEU PAC, LTD. 510(k) NO: K021841(TRADITIONAL)
ATTN: DONALD ALEXANDER PHONE NO : 262-542-3100
SMITHS MEDICAL SE DECISION MADE: 17-JUL-03
N7 W22025 JOHNSON ROAD 510(k) SUMMARY AVAILABLE FROM FDA
WAUKESHA, WI 53186-1856
DEVICE: PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT
PORTEX, INC. 510(k) NO: K031057(TRADITIONAL)
ATTN: TIMOTHY J TALCOTT PHONE NO : 603-352-3812
10 BOWMAN DR. SE DECISION MADE: 18-JUL-03
KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, BLUE, NON-STERILE
PT. WRP BUANA MULTICORPORA 510(k) NO: K032007(TRADITIONAL)
ATTN: NG POY SIN PHONE NO : 061 694 2461
JALAN JERMAL #20B, KELURAHAN SE DECISION MADE: 28-JUL-03
SEI MATI, MEDAN LABUHAN KM 17 510(k) SUMMARY AVAILABLE FROM FDA
MEDAN, INDONESIA 20252
DEVICE: FASTPACK FREE T4 IMMUNOASSAY
QUALIGEN, INC. 510(k) NO: K030329(TRADITIONAL)
ATTN: DOROTHY DEINZER PHONE NO : 760-918-9165
2042 CORTE DEL NOGAL SE DECISION MADE: 03-JUL-03
CARLSBAD, CA 92009-1410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIUS 018 COUGAR WIRE
RADIUS MEDICAL TECHNOLOGIES, INC. 510(k) NO: K032129(SPECIAL)
ATTN: DEBBIE IAMPIETRO PHONE NO : 508-435-9893
7 TIFFANY TRAIL SE DECISION MADE: 17-JUL-03
HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XPECT INFLUENZA A/B
REMEL INC 510(k) NO: K031565(TRADITIONAL)
ATTN: MARY ANN SILVIUS PHONE NO : 913-895-4054
12076 SANTA FE DRIVE SE DECISION MADE: 17-JUL-03
LENEXA, KS 66215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S7 ELITE AND AUTOSET SPIRIT CPAP SYSTEMS WITH RESLINK
RESMED LTD. 510(k) NO: K024191(TRADITIONAL)
ATTN: ROGER KOTTER PHONE NO : 858-746-2282
14040 DANIELSON ST. SE DECISION MADE: 02-JUL-03
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIPAP HARMONY VENTILATORY SUPPORT SYSTEM
RESPIRONICS, INC. 510(k) NO: K031656(SPECIAL)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120
1001 MURRY RIDGE LN. SE DECISION MADE: 30-JUL-03
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E
RITA MEDICAL SYSTEMS INC 510(k) NO: K031926(SPECIAL)
ATTN: ERIN MAZZONE PHONE NO : 650-314-3400
967 N. SHORELINE BLVD. SE DECISION MADE: 17-JUL-03
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FERRITIN GENERATION 2
ROCHE DIAGNOSTICS CORP. 510(k) NO: K031650(TRADITIONAL)
ATTN: KAY A TAYLOR PHONE NO : 317-521-3544
9115 HAGUE RD. SE DECISION MADE: 17-JUL-03
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCU-CHEK COMPACT TEST STRIP
ROCHE DIAGNOSTICS CORP. 510(k) NO: K031755(SPECIAL)
ATTN: SCOTT THIEL PHONE NO : 800-428-5074
9115 HAGUE RD. SE DECISION MADE: 03-JUL-03
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBAS INTEGRA CHOLESTEROL GEN. 2
ROCHE DIAGNOSTICS CORP. 510(k) NO: K031824(SPECIAL)
ATTN: SHERRI L COENEN PHONE NO : 317-521-3831
9115 HAGUE RD. SE DECISION MADE: 09-JUL-03
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBAS INTEGRA CARBON DIOXIDE ASSAY
ROCHE DIAGNOSTICS CORP. 510(k) NO: K031879(SPECIAL)
ATTN: SHERRI L COENEN PHONE NO : 317-521-3831
9115 HAGUE RD. SE DECISION MADE: 17-JUL-03
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL
ROCHE DIAGNOSTICS CORP. 510(k) NO: K031880(SPECIAL)
ATTN: SHERRI L COENEN PHONE NO : 317-521-3831
9115 HAGUE RD. SE DECISION MADE: 16-JUL-03
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC
ROCHE DIAGNOSTICS CORP. 510(k) NO: K032089(SPECIAL)
ATTN: SHERRI L COENEN PHONE NO : 317-521-3831
9115 HAGUE RD. SE DECISION MADE: 30-JUL-03
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MR FIBER OPTIC ECG GATING SYSTEM
SA INSTRUMENTS, INC. 510(k) NO: K031731(TRADITIONAL)
ATTN: G. RONALD MORRIS PHONE NO : 631-689-9804
65 MAIN STREET SE DECISION MADE: 30-JUL-03
STONY BROOK, NY 11790 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAUFLON MULTIPURPOSE SOLUTION - NO RUB
SAUFLON PHARMACEUTICALS, LTD. 510(k) NO: K030278(TRADITIONAL)
ATTN: LIGIA DELACRUZ PHONE NO : 44 208 3224200
49-53 YORK ST. SE DECISION MADE: 30-JUL-03
TWICKENHAM, MIDDLESEX, UNITED KING510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT,
SCANTIBODIES LABORATORY, INC. 510(k) NO: K031534(TRADITIONAL)
ATTN: RICHARD LENART PHONE NO : 619-258-9300
9336 ABRAHAM WAY SE DECISION MADE: 30-JUL-03
SANTEE, CA 92071 510(k) STATEMENT
DEVICE: UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS
SEASPINE 510(k) NO: K031381(TRADITIONAL)
ATTN: DIANA SMITH PHONE NO : 619-251-9132
727 PARK BLVD. SE DECISION MADE: 30-JUL-03
SAN DIEGO, CA 92101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEZ SAFETY SYRINGE
SEZ CORPORATION 510(k) NO: K031163(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO 7007 SE DECISION MADE: 08-JUL-03
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VINYL EXAM GLOVES, POWDER-FREE, YELLOW
SHANGHAI JIAWANG INDUSTRIAL CO. LT510(k) NO: K031854(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 25-JUL-03
SPARKS, NV 89434-9550 510(k) STATEMENT
DEVICE: GLASIONOMER FX-II
SHOFU DENTAL CORP. 510(k) NO: K031467(TRADITIONAL)
ATTN: ROBERT NOBLE PHONE NO : 760-736-3277
1225 STONE DR. SE DECISION MADE: 17-JUL-03
SAN MARCOS, CA 92069-4059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON CV70 CARDIOVASCULAR SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K032111(TRADITIONAL)
ATTN: CAREY CHAVEZ PHONE NO : 425-557-1683
22010 S.E. 51ST ST. SE DECISION MADE: 18-JUL-03
ISSAQUAH, WA 98029-7298 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SEQUOIA 8.0 DIAGNOSTIC ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K032114(TRADITIONAL)
ATTN: JERRY W TSUTSUMI PHONE NO : 650-943-7286
1230 SHOREBIRD WAY SE DECISION MADE: 21-JUL-03
P O BOX 7393 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94039-7393 THIRD PARTY REVIEW
DEVICE: PEEK TETRIS SPINAL IMPLANT
SIGNUS MEDICAL LLC. 510(k) NO: K031757(SPECIAL)
ATTN: AL ALEXANDER PHONE NO : 763-287-3830
4050 OLSON MEMORIAL HIGHWAY SE DECISION MADE: 30-JUL-03
SUITE 350 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55422
DEVICE: SINCLAIR WOUND AND SKIN EMULSION
SINCLAIR PHARMACEUTICALS, LTD. 510(k) NO: K024367(TRADITIONAL)
ATTN: MICHAEL KILLEEN PHONE NO : 441 483 428611
BOROUGH RD. SE DECISION MADE: 28-JUL-03
GODALMING, SURREY, UNITED KINGDOM 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OXINIUM FEMORAL HEADS
SMITH & NEPHEW, INC. 510(k) NO: K030766(SPECIAL)
ATTN: KIM P KELLY PHONE NO : 901-399-6566
1450 E. BROOKS RD. SE DECISION MADE: 25-JUL-03
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXTERNAL FIXATION SYSTEMS
SMITH & NEPHEW, INC. 510(k) NO: K031181(TRADITIONAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487
1450 E. BROOKS RD. SE DECISION MADE: 14-JUL-03
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318
SMITH & NEPHEW, INC. 510(k) NO: K031685(SPECIAL)
ATTN: JASON BILOBRAM PHONE NO : 508-261-3699
130 FORBES BLVD. SE DECISION MADE: 01-JUL-03
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCANLUBE
SONOTECH, INC. 510(k) NO: K031222(TRADITIONAL)
ATTN: MARGARET J LARSON PHONE NO : 360-671-9121
774 MARINE DR. SE DECISION MADE: 23-JUL-03
BELLINGHAM, WA 98225 510(k) STATEMENT
DEVICE: SCANTEC PAD
SONOTECH, INC. 510(k) NO: K031894(SPECIAL)
ATTN: MARGARET J LARSON PHONE NO : 360-671-9121
774 MARINE DR. SE DECISION MADE: 18-JUL-03
BELLINGHAM, WA 98225 510(k) STATEMENT
DEVICE: BENCO SPHERICAL
SOUTHERN DENTAL INDUSTRIES, INC. 510(k) NO: K031658(TRADITIONAL)
ATTN: SAMANTHA J CHEETHAM PHONE NO : 630-238-8300
729 N. ROUTE 83, SUITE 315 SE DECISION MADE: 29-JUL-03
BENSENVILLE, IL 60106 510(k) STATEMENT
DEVICE: SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM
SPINAL CONCEPTS, INC. 510(k) NO: K030087(ABBREVIATED)
ATTN: LISA PETERSON PHONE NO : 512-918-2700
5301 RIATA PARK COURT SE DECISION MADE: 17-JUL-03
BLDG F 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78727
DEVICE: MODIFICATION TO FORTITUDE CEMENT RESTRICTOR
SPINAL CONCEPTS, INC. 510(k) NO: K031837(SPECIAL)
ATTN: LISA PETERSON PHONE NO : 512-533-1080
5301 RIATA PARK CT., BLDG. F SE DECISION MADE: 24-JUL-03
AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORLON NONABSORABLE SURGICAL SUTURE USP
SRI ORION PHARMACEUTICALS & SUTURE510(k) NO: K030177(ABBREVIATED)
ATTN: NORMAN F ESTRIN PHONE NO : 301-279-2899
9109 COPENHAVER DR. SE DECISION MADE: 21-JUL-03
POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEEL CS CATHETER DELIVERY SYSTEM
ST. JUDE MEDICAL 510(k) NO: K031906(SPECIAL)
ATTN: MIKE BURNSIDE PHONE NO : 952-933-4700
14901 DEVEAU PL. SE DECISION MADE: 18-JUL-03
MINNETONKA, MN 55345-2126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STELLARTECH COAGULATION SYSTEM, MODELS (1100C-115 & 1100C-230)
STELLARTECH RESEARCH CORP. 510(k) NO: K032062(SPECIAL)
ATTN: JAMES R SANTOS PHONE NO : 408-331-3000
1346 BORDEAUX DR. SE DECISION MADE: 29-JUL-03
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ITI DENTAL IMPLANT SYSTEM
STRAUMANN USA 510(k) NO: K031055(TRADITIONAL)
ATTN: LINDA JALBERT PHONE NO : 781-890-0001
RESERVOIR PLACE, SE DECISION MADE: 07-JUL-03
1601 TRAPELO ROAD 510(k) SUMMARY AVAILABLE FROM FDA
WALTHAM, MA 02154
DEVICE: THE SUAD DEVICE
STRONG DENTAL INC. 510(k) NO: K023836(ABBREVIATED)
ATTN: CLYDE A TAKEGUCHI PHONE NO : 703-406-0906
21525 RIDGETOP CIRCLE SE DECISION MADE: 08-JUL-03
SUITE 320 510(k) SUMMARY AVAILABLE FROM FDA
STERLING, VA 20166
DEVICE: MODIFICATION TO STRYKER PAINPUMP
STRYKER INSTRUMENTS 510(k) NO: K031249(TRADITIONAL)
ATTN: NICOLE PETTY PHONE NO : 269-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 21-JUL-03
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUNDER CENTRAL VENOUS CATHETER KIT, MODELS SD-3L55F30J AND SD-3L
SUNDER BIOMEDICAL TECH. CO., LTD. 510(k) NO: K024007(TRADITIONAL)
ATTN: TONY HUNG PHONE NO : 886 4 23755650
10F-1, 1-67, WU-CHUAN RD. SE DECISION MADE: 14-JUL-03
TAICHUNG CITY, CHINA (TAIWAN) 403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1
SURGITECH, INC. 510(k) NO: K031576(TRADITIONAL)
ATTN: CHRISTOPHER CROWELL PHONE NO : 760-450-0194
2424 VISTA WAY, SUITE 300 SE DECISION MADE: 31-JUL-03
OCEANSIDE, CA 92054 510(k) STATEMENT
DEVICE: SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING THE
SURGRX INC 510(k) NO: K031133(TRADITIONAL)
ATTN: LINDA OLESON PHONE NO : 650-938-0424
2629-B TERMINAL BLVD. SE DECISION MADE: 03-JUL-03
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM
SYBARITIC, INC. 510(k) NO: K024307(TRADITIONAL)
ATTN: RANDALL E BERGLUND PHONE NO : 952-703-5369
9220 JAMES AVE. SOUTH SE DECISION MADE: 02-JUL-03
BLOOMINGTON, MN 55431 510(k) STATEMENT
DEVICE: FILL-IN
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K031476(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 W. COLLINS AVE. SE DECISION MADE: 02-JUL-03
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES ANTERIOR CERVICAL LOCKING PLATE (ACLP) SYSTEM
SYNTHES (USA) 510(k) NO: K031276(TRADITIONAL)
ATTN: JON GILBERT PHONE NO : 484-356-9615
1690 RUSSELL RD. SE DECISION MADE: 02-JUL-03
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM
SYNTHES (USA) 510(k) NO: K031555(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 08-JUL-03
P.O. BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: SYNTHES SMALL COBINATION CLAMP-MR SAFE
SYNTHES (USA) 510(k) NO: K031724(TRADITIONAL)
ATTN: BONNIE SMITH PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 14-JUL-03
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS
SYNTHES (USA) 510(k) NO: K031807(SPECIAL)
ATTN: BONNIE J SMITH PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 02-JUL-03
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAGA VELOCITY HUMIDIFIER
TAGA MEDICAL TECHNOLOGIES, INC. 510(k) NO: K031179(TRADITIONAL)
ATTN: GARY AUSTIN PHONE NO : 440-602-8242
34675 VOKES DR STE 105 SE DECISION MADE: 17-JUL-03
EASTLAKE, OH 44095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C. DIFF CHEK - 30
TECHLAB, INC. 510(k) NO: K030991(TRADITIONAL)
ATTN: DAVID M LYERLY PHONE NO : 540-953-1664
1861 PRATT DR., STE. 1030 SE DECISION MADE: 11-JUL-03
BLACKSBURG, VA 24060-6364 510(k) STATEMENT
DEVICE: C. DIFF CHEK - 60
TECHLAB, INC. 510(k) NO: K030992(TRADITIONAL)
ATTN: DAVID M LYERLY PHONE NO : 540-953-1664
1861 PRATT DR., STE. 1030 SE DECISION MADE: 11-JUL-03
BLACKSBURG, VA 24060-6364 510(k) STATEMENT
DEVICE: MX 300 OXYGEN MONITOR
TELEDYNE ANALYTICAL INSTRUMENTS 510(k) NO: K024155(TRADITIONAL)
ATTN: RAY KHAJAVI PHONE NO : 626-934-1502
16830 CHESTNUT ST. SE DECISION MADE: 17-JUL-03
CITY OF INDUSTRY, CA 91749 510(k) STATEMENT
DEVICE: RX300 OXYGEN ANALYZER
TELEDYNE ANALYTICAL INSTRUMENTS 510(k) NO: K024228(TRADITIONAL)
ATTN: RAY KHAJAVI PHONE NO : 626-934-1502
16830 CHESTNUT ST. SE DECISION MADE: 17-JUL-03
CITY OF INDUSTRY, CA 91749 510(k) STATEMENT
DEVICE: TELZUIT CARDIAC MONITORING SYSTEM
TELZUIT TECHNOLOGIES, INC. 510(k) NO: K031229(ABBREVIATED)
ATTN: CYNTHIA J.M. NOLET PHONE NO : 919-859-4207
49 PLAIN ST. SE DECISION MADE: 09-JUL-03
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIRTUOSAPH
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K031891(TRADITIONAL)
ATTN: KIM AVES PHONE NO : 800-262-3304
6200 JACKSON RD. SE DECISION MADE: 29-JUL-03
ANN ARBOR, MI 48103 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TERUMO SURGUARD 2 SAFETY NEEDLE
TERUMO MEDICAL CORP. 510(k) NO: K031453(TRADITIONAL)
ATTN: BARBARA SMITH PHONE NO : 410-392-7241
950 ELKTON BLVD. SE DECISION MADE: 08-JUL-03
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEH
THE BINDING SITE, LTD. 510(k) NO: K031016(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 15-JUL-03
2425 WEST OLYMPIC BOULEVARD 510(k) SUMMARY AVAILABLE FROM FDA
SANTA MONICA, CA 90404
DEVICE: THERIFIL BONE FILLER
THERICS, INC. 510(k) NO: K031040(TRADITIONAL)
ATTN: UMBERTO V PARROTTA, JR PHONE NO : 609-501-7200
115 CAMPUS DR. SE DECISION MADE: 24-JUL-03
PRINCETON, NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPI DENTAL IMPLANT ABUTMENTS
THOMMEN MEDICAL, AG 510(k) NO: K031747(SPECIAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
4329 GRAYDON RD. SE DECISION MADE: 02-JUL-03
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THYRO TEST
THRYOTEC 510(k) NO: K030912(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808
163 CABOT STREET SE DECISION MADE: 25-JUL-03
BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TINNITUS RX
TINNITUS CONTROL, INC. 510(k) NO: K031624(TRADITIONAL)
ATTN: RUSS PAGANO PHONE NO : 202-546-1262
719 A STREET, NE SE DECISION MADE: 24-JUL-03
WASHINGTON, DC 20002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001
TRANS VASCULAR INCORPORATED 510(k) NO: K031920(SPECIAL)
ATTN: RICHARD E ANDERSON PHONE NO : 650-473-4500
1505-D ADAMS DR. SE DECISION MADE: 23-JUL-03
MENLO PARK, CA 94925 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K031545(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 216-351-8735
982 KEYNOTE CIRCLE SUITE 6 SE DECISION MADE: 16-JUL-03
CLEVELAND, OH 44131 510(k) STATEMENT
DEVICE: MODIFICATION TO WBR, MODEL HR
U.C.G. TECHNOLOGIES LTD. 510(k) NO: K031874(SPECIAL)
ATTN: DAN LAOR PHONE NO : 972 4 8546611
BUILDING # 30 MATAM SE DECISION MADE: 18-JUL-03
HAIFA, ISRAEL 31905 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIMA III TOTALSENSE TORSO COIL
USA INSTRUMENTS, INC. 510(k) NO: K031365(TRADITIONAL)
ATTN: CHRISTIE SHUMAKER PHONE NO : 330-562-1000
1515 DANNER DR. SE DECISION MADE: 18-JUL-03
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL
USA INSTRUMENTS, INC. 510(k) NO: K031366(TRADITIONAL)
ATTN: CHRISTIE SHUMAKER PHONE NO : 330-562-1000
1515 DANNER DR. SE DECISION MADE: 11-JUL-03
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BUTLER GUM PROPHY PASTE WITH NOVAMIN
USBIOMATERIALS CORP. 510(k) NO: K024343(TRADITIONAL)
ATTN: DAVID C GREENSPAN PHONE NO : 386-418-1551
13709 PROGRESS BLVD. SE DECISION MADE: 11-JUL-03
#23 510(k) SUMMARY AVAILABLE FROM FDA
ALACHUA, FL 32615
DEVICE: VASC-ALERT
VASC-ALERT L.L.C. 510(k) NO: K030456(TRADITIONAL)
ATTN: JOHN KENNEDY PHONE NO : 773-334-8177
1807 W. SUNNYSIDE AVE. SE DECISION MADE: 11-JUL-03
SUITE 301 510(k) SUMMARY AVAILABLE FROM FDA
CHICAGO, IL 60640
DEVICE: VENTLAB BACTERIAL FILTER, MODEL BF100
VENTLAB CORP. 510(k) NO: K030271(TRADITIONAL)
ATTN: ROBERT M KELLY PHONE NO : 336-492-2636
2934 HWY. 601 NORTH SE DECISION MADE: 07-JUL-03
MOCKSVILLE, NC 27028 510(k) STATEMENT
DEVICE: SPIROSOFT
VIASYS HEALTHCARE GMBH 510(k) NO: K031194(SPECIAL)
ATTN: EARL DRAPER PHONE NO : 714-283-2228
22705 SAVI RANCH PKWY. SE DECISION MADE: 30-JUL-03
YORBA LINDA, CA 92887 510(k) STATEMENT
DEVICE: ENDOS DC
VILLA SISTEMI MEDICALI S.P.A. 510(k) NO: K030634(ABBREVIATED)
ATTN: ANDREW HRYNDZA PHONE NO : 847-288-7000
11550 WEST KING ST. SE DECISION MADE: 21-JUL-03
FRANKLIN PARK, IL 60131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RSV (RADIOLOGY SYSTEM VISIODENT
VISIODENT SA 510(k) NO: K031448(TRADITIONAL)
ATTN: CLAUDE D BERTHOIN PHONE NO : 386-672-0450
110 E GRANADA BLVD. SE DECISION MADE: 31-JUL-03
STE 207 & 208; PO BOX 36 510(k) STATEMENT
ORMOND BEACH, FL 32175-0036
DEVICE: SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING
VISION-SCIENCES, INC. 510(k) NO: K031790(TRADITIONAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVE. SE DECISION MADE: 02-JUL-03
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REUSABLE MULTIPLE-PATIENT LIFESHIRT WITH VIVOLOGIC ANALYSIS SOFT
VIVOMETRICS, INC. 510(k) NO: K031550(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813
555 THIRTEENTH ST. NW SE DECISION MADE: 29-JUL-03
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIT, CAUTERY, TEHRMAL,BATTERY-POWERED
WALSH MEDICAL DEVICES, INC. 510(k) NO: K030158(TRADITIONAL)
ATTN: DAVID STILES PHONE NO : 905 844 8344
1200 SOUTH SERVICE RD. WEST SE DECISION MADE: 17-JUL-03
UNIT 3 510(k) SUMMARY AVAILABLE FROM FDA
OAKVILLE, ONTARIO, CANADA L6L 5T7
DEVICE: BODY SIGNAL ECG ELECTRODE
WANDY RUBBER INDUSTRIAL CO., LTD 510(k) NO: K031174(TRADITIONAL)
ATTN: JANIS YANG PHONE NO : 886 2 26943185
NO.24, ALLEY 37, LANE 392 SE DECISION MADE: 10-JUL-03
FU TEH 1ST RD. 510(k) STATEMENT
SHI-CHIH, CHINA (TAIWAN) 221
DEVICE: COACH 888
WHEELCHAIR & SCOOTER EXPRESS 510(k) NO: K030758(TRADITIONAL)
ATTN: CHRIS TINSLEY PHONE NO : 620-325-2629
4905 A. SAN JACINTO SE DECISION MADE: 31-JUL-03
HOUSTON, TX 77004 510(k) STATEMENT
DEVICE: COACH 888W
WHEELCHAIR & SCOOTER EXPRESS 510(k) NO: K030760(TRADITIONAL)
ATTN: CHRIS TINSLEY PHONE NO : 620-325-2629
4905 A. SAN JACINTO SE DECISION MADE: 10-JUL-03
HOUSTON, TX 77004 510(k) STATEMENT
DEVICE: 5MP TFT LCD MONITOR SYSTEM IF2105A BY WIDE CORPORATION
WIDE CORPORATION 510(k) NO: K031929(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1100 LAKEVIEW BLVD. SE DECISION MADE: 08-JUL-03
DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: WIDE 3MP GRAYSCALE TFT LCD MONITOR IF2103A
WIDE CORPORATION 510(k) NO: K032174(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1100 LAKEVIEW BLVD. SE DECISION MADE: 24-JUL-03
DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: READI-STRAND, MODEL PSSTRAND
WORLDWIDE MEDICAL TECHNOLOGIES, IN510(k) NO: K023179(TRADITIONAL)
ATTN: GARY LAMOUREUX PHONE NO : 203-263-2579
426 MAIN ST. NORTH SE DECISION MADE: 02-JUL-03
WOODBURY, CT 06798-0505 510(k) STATEMENT
DEVICE: CELLPLEX TCP SYNTHETIC CANCELLOUS BONE
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K031817(SPECIAL)
ATTN: EHAB M ESMAIL PHONE NO : 901-867-4732
5677 AIRLINE RD. SE DECISION MADE: 17-JUL-03
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENTERALITE INFINITY ENTERAL FEEDING PUMP
ZEVEX INTL., INC. 510(k) NO: K031199(TRADITIONAL)
ATTN: SEAN M CURRY PHONE NO : 858-675-8200
16787 BERNARDO CENTER DR. SE DECISION MADE: 09-JUL-03
SUITE A-1 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92128
TOTAL 510(k)s THIS PERIOD 300
TOTAL WITH SUMMARIES 243
TOTAL WITH STATEMENTS 57
Updated August 5, 2003
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