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Medical Devices
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October 2003 510(k) Clearances
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-OCT-2003 THROUGH 31-OCT-2003
DEVICE: SWISS MASTER LIGHT
(EMS SA) ELECTRO MEDICAL SYSTEMS 510(k) NO: K032099(TRADITIONAL)
ATTN: CYNTHIA J M. NOLTE PHONE NO : 919-859-4207
49 PLAIN ST. SE DECISION MADE: 27-OCT-03
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294; AT
3M COMPANY 510(k) NO: K031012(TRADITIONAL)
ATTN: CYNTHIA LAMARUCCIOLA PHONE NO : 651-736-1523
3M CENTER, BLDG. 275-5W-06 SE DECISION MADE: 16-OCT-03
ST. PAUL, MN 55133-3275 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: 3M LIQUID BANDAGE, MODEL 120-LB
3M COMPANY 510(k) NO: K031263(TRADITIONAL)
ATTN: ANNA E MCRIGHT PHONE NO : 651-733-7948
3M CENTER, BLDG. 275-5W-06 SE DECISION MADE: 07-OCT-03
ST. PAUL, MN 55133-3275 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS
A & D ENGINEERING, INC. 510(k) NO: K032499(SPECIAL)
ATTN: JERRY WANG PHONE NO : 408-263-5333
1555 MC CANDLESS DR. SE DECISION MADE: 30-OCT-03
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CAL
ABBOTT LABORATORIES 510(k) NO: K032458(ABBREVIATED)
ATTN: DENISE FARMER PHONE NO : 847-938-5032
200 ABBOTT PARK RD. SE DECISION MADE: 06-OCT-03
ABBOTT PARK, IL 60064-6187 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUSONIC A-SCAN MODEL, 24-4000
ACCUTOME, INC. 510(k) NO: K032956(TRADITIONAL)
ATTN: JEFFREY L WRIGHT PHONE NO : 610-889-0200
263 GREAT VALLEY PKWY. SE DECISION MADE: 10-OCT-03
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
ADAC LABORATORIES 510(k) NO: K032724(TRADITIONAL)
ATTN: RANDY VADER PHONE NO : 608-288-6945
6400 ENTERPRISE LANE,STE.201 SE DECISION MADE: 09-OCT-03
MADISON, WI 53719 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FORTE GAMMA CAMERA SYSTEM
ADAC LABORATORIES 510(k) NO: K033254(TRADITIONAL)
ATTN: JOY M SACMAR PHONE NO : 408-468-3053
540 ALDER DR. SE DECISION MADE: 22-OCT-03
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ADEPT 1064/532/755 LASER
ADEPT MEDICAL CONCEPTS, INC. 510(k) NO: K032218(TRADITIONAL)
ATTN: JERRY MCFARLAND PHONE NO : 949-635-9238
29866 AVENIDA DE LAS BANDERAS SE DECISION MADE: 24-OCT-03
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADEPT 1064/532 LASER
ADEPT MEDICAL CONCEPTS, INC. 510(k) NO: K032220(TRADITIONAL)
ATTN: JERRY MCFARLAND PHONE NO : 949-635-9238
29866 AVENIDA DE LAS BANDERAS SE DECISION MADE: 24-OCT-03
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADEPT 1064/755 LASER
ADEPT MEDICAL CONCEPTS, INC. 510(k) NO: K032221(TRADITIONAL)
ATTN: JERRY MCFARLAND PHONE NO : 949-635-9238
29866 AVENIDA DE LAS BANDERAS SE DECISION MADE: 24-OCT-03
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANS AXXESS PERCUTANEOUS LEAD
ADVANCED NEUROMODULATION SYSTEMS 510(k) NO: K032034(TRADITIONAL)
ATTN: KATRYNA WARREN PHONE NO : 972-309-8109
6501 WINDCREST DRIVE SUITE 100 SE DECISION MADE: 03-OCT-03
PLANO, TX 75024 510(k) STATEMENT
DEVICE: PLACER
ADVANCED NEUROMODULATION SYSTEMS 510(k) NO: K032349(TRADITIONAL)
ATTN: KATRYNA WARREN PHONE NO : 972-309-8000
6501 WINDCREST DRIVE SUITE 100 SE DECISION MADE: 03-OCT-03
PLANO, TX 75024 510(k) STATEMENT
DEVICE: MODIFICATION TO RENEW LEAD EXTENSION
ADVANCED NEUROMODULATION SYSTEMS 510(k) NO: K032751(SPECIAL)
ATTN: DANIELLE ALARCON PHONE NO : 972-309-8000
6501 WINDCREST DRIVE SUITE 100 SE DECISION MADE: 06-OCT-03
PLANO, TX 75024 510(k) STATEMENT
DEVICE: HEART 2006
AEROTEL MEDICAL SYSTEMS (1998) LTD510(k) NO: K032736(SPECIAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 SE DECISION MADE: 03-OCT-03
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM
ALARA, INC. 510(k) NO: K032210(TRADITIONAL)
ATTN: DIANE M KING PHONE NO : 510-723-0110
2545 BARRINGTON CT. SE DECISION MADE: 02-OCT-03
HAYWARD, CA 94545-1134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR
ALBERT BROWNE LTD. 510(k) NO: K032801(SPECIAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 919-859-4207
49 PLAIN ST. SE DECISION MADE: 17-OCT-03
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED ELECTROPHYSIOLOGY CATHETER
ALLIANCE MEDICAL CORP. 510(k) NO: K030279(TRADITIONAL)
ATTN: MOIRA BARTON PHONE NO : 480-763-5300
10232 SOUTH 51ST ST. SE DECISION MADE: 03-OCT-03
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALOKA SSD-5000 V5.0 ULTRASOUND SYSTEM
ALOKA CO., LTD. 510(k) NO: K033311(TRADITIONAL)
ATTN: RICHARD J CEHOVSKY PHONE NO : 203-269-5088
10 FAIRFIELD BLVD. SE DECISION MADE: 29-OCT-03
WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM
ALSIUS CORP. 510(k) NO: K030421(TRADITIONAL)
ATTN: KENNETH A COLLINS PHONE NO : 949-453-0150
15770 LAGUNA CANYON, SUITE 150 SE DECISION MADE: 23-OCT-03
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST
AMEDICA BIOTECH, INC. 510(k) NO: K031497(TRADITIONAL)
ATTN: JEFF CHEN PHONE NO : 510-785-5980
28301 INDUSTRIAL BLVD SUITE K SE DECISION MADE: 17-OCT-03
HAYWARD, CA 94545 510(k) STATEMENT
DEVICE: EASYGLUCO, MODEL IGM0002
AMERICAN HEALTHCARE INC. 510(k) NO: K031501(TRADITIONAL)
ATTN: EDWARD LETCO PHONE NO : 917-402-5900
304 PARK AVENUE SOUTH SE DECISION MADE: 16-OCT-03
SUITE 206 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10010
DEVICE: REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEM
AMERICAN I.V. PRODUCTS, INC. 510(k) NO: K032789(TRADITIONAL)
ATTN: GREGORY FALK PHONE NO : 410-787-1300
7485 SHIPLEY AVE. SE DECISION MADE: 09-OCT-03
HANOVER, MD 21076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMSURE FOLEY CATHETER
AMSINO INTERNATIONAL, INC. 510(k) NO: K030120(TRADITIONAL)
ATTN: CHING CHING SEAH PHONE NO : 909-390-5688
4501 BRICKELL PRIVADO ST. SE DECISION MADE: 29-OCT-03
ONTARIO, CA 91761 510(k) STATEMENT
DEVICE: COMBI-SCREEN, MODELS 10SL AND 11SL
ANALYTICON BIOTECHNOLOGIES AG 510(k) NO: K023885(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 21-OCT-03
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL IR 1200 INSULIN PUMP
ANIMAS CORP. 510(k) NO: K032257(TRADITIONAL)
ATTN: MICHAEL J ANDREWS PHONE NO : 610-644-8990
590 E. LANCASTER AVE. SE DECISION MADE: 16-OCT-03
FRAZER, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS ULTRASONIC SURGICAL SYSTEM
AOMORI OLYMPUS CO., LTD. 510(k) NO: K031523(TRADITIONAL)
ATTN: TINA STEFFANIE-OAK PHONE NO : 631-844-5477
2 CORPORATE CENTER DR. SE DECISION MADE: 01-OCT-03
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109
APPLIED DIABETES RESEARCH, INCORPO510(k) NO: K033099(SPECIAL)
ATTN: JIM BARLEY PHONE NO : 949-364-9349
28481 LAFALDA SE DECISION MADE: 16-OCT-03
LAGUNA NIGUEL, CA 92677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTICAL SEPARATOR
APPLIED MEDICAL RESOURCES 510(k) NO: K032889(TRADITIONAL)
ATTN: CHERYL BLAKE PHONE NO : 949-713-8327
22872 AVENIDA EMPRESA SE DECISION MADE: 02-OCT-03
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO SUTURE CLINCH
APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K033024(SPECIAL)
ATTN: CHERYL BLAKE PHONE NO : 949-713-8327
22872 AVENIDA EMPRESSA SE DECISION MADE: 24-OCT-03
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBI
ARROW INTL., INC. 510(k) NO: K032962(SPECIAL)
ATTN: ELIZABETH PRICE PHONE NO : 610-378-0131
2400 BERNVILLE RD. SE DECISION MADE: 29-OCT-03
READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SC
ARTHREX, INC. 510(k) NO: K032098(TRADITIONAL)
ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553
2885 SOUTH HORSESHOE DR. SE DECISION MADE: 07-OCT-03
NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROCARE ENT PLASMA WANDS
ARTHROCARE CORP. 510(k) NO: K033257(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-735-6426
680 VAQUEROS AVE. SE DECISION MADE: 30-OCT-03
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE
ARTHROTEK, INC. 510(k) NO: K032072(TRADITIONAL)
ATTN: TRACY J BICKEL PHONE NO : 574-372-1761
P.O. BOX 587 SE DECISION MADE: 01-OCT-03
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASCENSION MODULAR RADIAL HEAD
ASCENSION ORTHOPEDICS, INC. 510(k) NO: K032686(TRADITIONAL)
ATTN: PETER STRZEPA PHONE NO : 512-836-5001
8200 CAMERON RD., SUITE C-140 SE DECISION MADE: 22-OCT-03
AUSTIN, TX 78754-3832 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVITA TS8/TS9 SERIES IR EAR/FOREHEAD THERMOMETER
AVITA CORPORATION 510(k) NO: K031503(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-9488
3892 SOUTH AMERICA WEST TRAIL, SE DECISION MADE: 24-OCT-03
FLAGGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERIFIX CATHETER CONNECTOR
B. BRAUN MEDICAL, INC. 510(k) NO: K032144(TRADITIONAL)
ATTN: AMY SMITH PHONE NO : 610-266-0500
901 MARCON BLVD. SE DECISION MADE: 01-OCT-03
ALLENTOWN, PA 18103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTRIAXONE 0.5-64 UG/M
BECTON, DICKINSON AND COMPANY 510(k) NO: K032655(TRADITIONAL)
ATTN: KATHRYN B POWERS PHONE NO : 410-316-4260
7 LOVETON CIR. SE DECISION MADE: 06-OCT-03
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM
BEHAVIORAL TECHNOLOGY, INC. 510(k) NO: K033126(SPECIAL)
ATTN: SUSAN E OLSEN PHONE NO : 801-363-9017
24 M ST., #1 SE DECISION MADE: 29-OCT-03
SALT LAKE CITY, UT 84103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BETEC RETRACTABLE SAFETY SYRINGE (5ML)
BETEC MEDICAL SCIENCE CO., LTD. 510(k) NO: K031909(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-9488
3892 SOUTH AMERICA WEST TRAIL SE DECISION MADE: 07-OCT-03
FLAGGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL S
BINAX, INC. 510(k) NO: K032166(TRADITIONAL)
ATTN: PAMELA ANGELL PHONE NO : 207-772-3988
217 READ ST. SE DECISION MADE: 21-OCT-03
PORTLAND, ME 04103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROFUSION BONE VOID FILLER KIT
BIOGENERATION 510(k) NO: K031838(TRADITIONAL)
ATTN: BERNARD F GRISONI PHONE NO : 901-380-9411
9160 HIGHWAY 64 SE DECISION MADE: 30-OCT-03
SUITE 12 510(k) SUMMARY AVAILABLE FROM FDA
LAKELAND, TN 38002
DEVICE: THE MAESTRO SYSTEM 3.0MM DIAMETER IMPLANT
BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K032351(TRADITIONAL)
ATTN: WINSTON D GREER PHONE NO : 205-967-7880
ONE PERIMETER PARK SOUTH SE DECISION MADE: 21-OCT-03
SUITE 230, SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
BIRMINGHAM, AL 35243
DEVICE: BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPUR
BIOLAB EQUIPMENT CANADA LTD. 510(k) NO: K030348(TRADITIONAL)
ATTN: JERRY PONIKVAR PHONE NO : 905 882 2068
128 GRANDVIEW AVE. SE DECISION MADE: 21-OCT-03
THORNHILL, ONTARIO, CANADA L3T 1H6510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LASERSMILE
BIOLASE TECHNOLOGY, INC. 510(k) NO: K030539(TRADITIONAL)
ATTN: IOANA M RIZOIU PHONE NO : 949-361-1200
981 CALLE AMANECER SE DECISION MADE: 10-OCT-03
SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLUID SAMPLE RETRIEVAL SYSTEM
BIOMED PERSONAL METABOLIC AND NUTR510(k) NO: K030394(TRADITIONAL)
ATTN: SUSAN B FENTRESS PHONE NO : 901-680-7319
6075 POPLAR AVE. SE DECISION MADE: 27-OCT-03
SUITE 500 510(k) STATEMENT
MEMPHIS, TN 38119
DEVICE: VITEK GRAM NEGATIVE GATIFLOXACIN
BIOMERIEUX, INC. 510(k) NO: K032711(TRADITIONAL)
ATTN: NANCY WEAVER PHONE NO : 314-731-8695
595 ANGLUM RD. SE DECISION MADE: 31-OCT-03
HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN
BIOMERIEUX, INC. 510(k) NO: K032738(TRADITIONAL)
ATTN: NANCY WEAVER PHONE NO : 314-731-8695
595 ANGLUM DR. SE DECISION MADE: 31-OCT-03
HAZELWOOD, MO 63042-2320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 GRAM POSITIVE LINEZOLID
BIOMERIEUX, INC. 510(k) NO: K032766(TRADITIONAL)
ATTN: NANCY WEAVER PHONE NO : 314-731-8695
595 ANGLUM RD. SE DECISION MADE: 31-OCT-03
HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOPKIN WOUND DRESSING
BIOMET MERCK GMBH 510(k) NO: K031684(TRADITIONAL)
ATTN: THOMAS KIEWITT PHONE NO : 49 615 1722004
ATLES WIDALMI 12 SE DECISION MADE: 30-OCT-03
RIED BEI KERZERS, SWITZERLAND 3216510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS
BIONOSTICS, INC. 510(k) NO: K032819(TRADITIONAL)
ATTN: KATHLEEN STORRO PHONE NO : 978-772-7070
7 JACKSON RD. SE DECISION MADE: 20-OCT-03
DEVENS, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHERON PTA CATHETER
BIOTRONIK, INC. 510(k) NO: K033217(TRADITIONAL)
ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374
6024 JEAN RD. SE DECISION MADE: 31-OCT-03
LAKE OSWEGO, OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS
BLACKSTONE MEDICAL, INC. 510(k) NO: K032700(SPECIAL)
ATTN: DEAN E CIPORKIN PHONE NO : 413-726-2513
90 BROOKSDALE DR. SE DECISION MADE: 09-OCT-03
SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VAXCEL PLUS CHRONIC DIALYSIS CATHETER
BOSTON SCIENTIFIC CORP. 510(k) NO: K032712(SPECIAL)
ATTN: NICHOLAS CONDAKES PHONE NO : 508-652-5003
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 02-OCT-03
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
BOSTON SCIENTIFIC CORP. 510(k) NO: K032930(SPECIAL)
ATTN: KATHLEEN MORAHAN PHONE NO : 508-652-5942
ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 23-OCT-03
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRM2 BRAIN MONITOR
BRAINZ INSTRUMENTS LTD. 510(k) NO: K033010(TRADITIONAL)
ATTN: CHRIS MANDER PHONE NO : 011 649 9788855
25 CARBINE ROAD MT. WELLINGTON SE DECISION MADE: 10-OCT-03
PO BOX 51-078, PARURANGA 510(k) SUMMARY AVAILABLE FROM FDA
AUCKLAND, NEW ZEALAND THIRD PARTY REVIEW
DEVICE: BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT);
BRAUN GMBH 510(k) NO: K031928(ABBREVIATED)
ATTN: FRED SCHLADOR PHONE NO : 760-929-2170
6183 PASEO DEL MORTE SE DECISION MADE: 24-OCT-03
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92009
DEVICE: ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, MODELS 320100 & 320110
C.R. BARD, INC. 510(k) NO: K030627(TRADITIONAL)
ATTN: DEBORAH HERRINGTON PHONE NO : 978-323-2216
55 TECHNOLOGY DR. SE DECISION MADE: 23-OCT-03
LOWELL, MA 01851 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C.T.M. MOBILITY SCOOTER, MODEL HS-235
C.T.M. HOMECARE PRODUCT, INC. 510(k) NO: K032918(TRADITIONAL)
ATTN: ROBERT S MCQUATE PHONE NO : 602-788-5651
3636 E. COLUMBINE DR. SE DECISION MADE: 06-OCT-03
PHOENIX, AZ 85032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C.T.M. MOBILITY SCOOTER, MODEL HS-250
C.T.M. HOMECARE PRODUCT, INC. 510(k) NO: K032919(TRADITIONAL)
ATTN: ROBERT S MCQUATE PHONE NO : 602-788-5651
3636 E. COLUMBINE DR. SE DECISION MADE: 15-OCT-03
PHOENIX, AZ 85032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS
CANDELA CORP. 510(k) NO: K033172(TRADITIONAL)
ATTN: LORRAINE CALZETTA-PATROVIC PHONE NO : 508-358-7637
530 BOSTON POST RD. SE DECISION MADE: 30-OCT-03
WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING
CARDINAL HEALTH 510(k) NO: K031301(TRADITIONAL)
ATTN: ERICA SETHI PHONE NO : 847-785-3337
1500 WAUKEGAN RD. BLDG. WM SE DECISION MADE: 15-OCT-03
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONE CEMENT RADIO-OPACIFIER
CARDINAL HEALTH 510(k) NO: K032388(TRADITIONAL)
ATTN: SHARON NICHOLS PHONE NO : 847-785-3311
1500 WAUKEGAN RD. SE DECISION MADE: 31-OCT-03
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO GLOBALCARDIO
CARDIOCOMM SOLUTIONS, INC. 510(k) NO: K033037(TRADITIONAL)
ATTN: JANET WAINMAN PHONE NO : 250 744 1822
3060 CEDAR HILL ROAD SE DECISION MADE: 31-OCT-03
SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA
VICTORIA, B.C., CANADA V8T 3J5
DEVICE: CAREMATIX WELLNESS SYSTEM
CAREMATIX INC. 510(k) NO: K031840(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 10-OCT-03
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPSILON DURASUL CONSTRAINED ACETABULAR LINER
CENTERPULSE ORTHOPEDICS, INC. 510(k) NO: K030923(TRADITIONAL)
ATTN: ROBERT M WOLFARTH PHONE NO : 512-432-9324
9900 SPECTRUM DR. SE DECISION MADE: 03-OCT-03
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP
CENTERPULSE ORTHOPEDICS, INC. 510(k) NO: K032348(TRADITIONAL)
ATTN: ROBERT M WOLFARTH PHONE NO : 512-432-9324
9900 SPECTRUM DR. SE DECISION MADE: 24-OCT-03
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3D INVIVO BY CSIST
CHUNG-SHAN INSTITUTE OF SCIENCE AN510(k) NO: K031567(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1100 LAKEVIEW BLVD. SE DECISION MADE: 02-OCT-03
DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME
CIBA VISION CORP. 510(k) NO: K032978(SPECIAL)
ATTN: PENNY NORTHCUTT PHONE NO : 678-415-3214
11460 JOHNS CREEK PKWY. SE DECISION MADE: 20-OCT-03
DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN C
CLINIQA CORPORATION 510(k) NO: K032074(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900
1432-B SOUTH MISSION RD. SE DECISION MADE: 21-OCT-03
FALLBROOK, CA 92028 510(k) STATEMENT
DEVICE: LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS A
CLINIQA CORPORATION 510(k) NO: K033162(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900
1432 SOUTH MISSION RD. SE DECISION MADE: 10-OCT-03
FALLBROOK, CA 92028 510(k) STATEMENT
DEVICE: CLUED UP MULTIPURPOSE SOLUTION- NO RUB
CLUED UP LIMITED 510(k) NO: K030910(TRADITIONAL)
ATTN: JENNY KOKSHUN PHONE NO : 442 083 224204
135 HIGH ST. SE DECISION MADE: 10-OCT-03
EGHAM, SURREY, UNITED KINGDOM TW20510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE
COAPT SYSTEMS, INC. 510(k) NO: K032698510(k) NO: (TRADITIONAL)
ATTN: LORI DONDIEGO PHONE NO : 650-461-7600
1820 EMBARCADERO RD. SE DECISION MADE: 23-OCT-03
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOTINE FOREHEAD DEVICE
COAPT SYSTEMS, INC. 510(k) NO: K032770(SPECIAL)
ATTN: LORI DONDIEGO PHONE NO : 650-461-7600
1820 EMBARCADERO RD. SE DECISION MADE: 08-OCT-03
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I-BEAM
COMPUTERIZED MEDICAL SYSTEMS, INC.510(k) NO: K032100(TRADITIONAL)
ATTN: KATHRYN STINSON PHONE NO : 314-993-0003
1145 CORPORATE LAKE DR. SE DECISION MADE: 02-OCT-03
ST. LOUIS, MO 63132-1716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOM
COOK VASCULAR, INC. 510(k) NO: K032223(TRADITIONAL)
ATTN: THOMAS J KARDOS PHONE NO : 724-845-8621
RT. 66, RIVER RD. SE DECISION MADE: 15-OCT-03
P.O. BOX 529 510(k) SUMMARY AVAILABLE FROM FDA
LEECHBURG, PA 15656-0529
DEVICE: ENK FIBEROPTIC ATOMIZER SET
COOK, INC. 510(k) NO: K031966(TRADITIONAL)
ATTN: JENNIFER J BOSLEY PHONE NO : 812-339-2235
750 DANIELS WAY SE DECISION MADE: 16-OCT-03
P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA
BLOOMINGTON, IN 47402-0489
DEVICE: GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET
COOK, INC. 510(k) NO: K032426(TRADITIONAL)
ATTN: JENNIFER J BOSLEY PHONE NO : 812-339-2235
750 DANIELS WAY SE DECISION MADE: 31-OCT-03
P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA
BLOOMINGTON, IN 47402-0489
DEVICE: PTA BALLOON CATHETER
COOK, INC. 510(k) NO: K032931(SPECIAL)
ATTN: KAREN BRADBURN PHONE NO : 800-346-2686
750 DANIELS WAY SE DECISION MADE: 22-OCT-03
P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA
BLOOMINGTON, IN 47402-0489
DEVICE: CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX
CORDIS EUROPA N.V. 510(k) NO: K032737(SPECIAL)
ATTN: KAREN WILK PHONE NO : 908-412-7257
7 POWDER HORN DR. SE DECISION MADE: 02-OCT-03
WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL
CORGENIX, INC. 510(k) NO: K032868(SPECIAL)
ATTN: NANCI DEXTER PHONE NO : 303-457-4345
12061 TEJON ST. SE DECISION MADE: 14-OCT-03
WESTMINSTER, CO 80234 510(k) STATEMENT
DEVICE: AUTOALIGN
CORTECHS LABS, INC. 510(k) NO: K032186(ABBREVIATED)
ATTN: ALLAN GREEN PHONE NO : 671-241-9588
6 13TH ST. SE DECISION MADE: 14-OCT-03
CHARLESTOWN, MA 02129-2027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275
CTF SYSTEMS (2001), INC. 510(k) NO: K030737(SPECIAL)
ATTN: DARYL WISDAHL PHONE NO : 604 941 8561
15-1750 MCLEAN AVE. SE DECISION MADE: 10-OCT-03
PORT COQUITLAM, B.C., CANADA V3C 1510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYNOSURE SMART FILE ND:YAG LASERS
CYNOSURE, INC. 510(k) NO: K031125(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
10 ELIZABETH DR. SE DECISION MADE: 09-OCT-03
CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYNOSURE SMART 2940D ER:YAG LASER
CYNOSURE, INC. 510(k) NO: K031389(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
10 ELIZABETH DR. SE DECISION MADE: 01-OCT-03
CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMART CO2 (SMART US 20D, SMART CLINIC) SURGICAL LASER
CYNOSURE, INC. 510(k) NO: K031440(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
10 ELIZABETH DR. SE DECISION MADE: 01-OCT-03
CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYNOSURE PHOTOGENICA VL
CYNOSURE, INC. 510(k) NO: K032565(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
10 ELIZABETH DR. SE DECISION MADE: 22-OCT-03
CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE MET
DADE BEHRING, INC. 510(k) NO: K032564(TRADITIONAL)
ATTN: RICHARD M VAUGHT PHONE NO : 302-631-6567
GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 31-OCT-03
BLDG. 500 MAIL BOX 514 510(k) SUMMARY AVAILABLE FROM FDA
P.O. BOX 6101, NEWARK, DE 19714-6101
DEVICE: DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MOD
DADE BEHRING, INC. 510(k) NO: K032573(TRADITIONAL)
ATTN: RICHARD M VAUGHT PHONE NO : 302-631-6567
GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 31-OCT-03
BLDG. 500 MAIL BOX 514 510(k) SUMMARY AVAILABLE FROM FDA
P.O. BOX 6101, NEWARK, DE 19714-6101
DEVICE: DIMENSION DRUG CALIBRATOR II, MODEL DC49C
DADE BEHRING, INC. 510(k) NO: K032574(TRADITIONAL)
ATTN: RICHARD M VAUGHT PHONE NO : 302-631-6567
GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 06-OCT-03
BLDG. 500 MAIL BOX 514 510(k) SUMMARY AVAILABLE FROM FDA
P.O. BOX 6101, NEWARK, DE 19714-6101
DEVICE: DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDG
DADE BEHRING, INC. 510(k) NO: K032798(TRADITIONAL)
ATTN: ANDREA M TASKER PHONE NO : 302-631-9454
GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 30-OCT-03
BLDG. 500 P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS
DANMAR PRODUCTS, INC. 510(k) NO: K013452(TRADITIONAL)
ATTN: KAREN A LINDNER PHONE NO : 734-761-1990
221 JACKSON INDUSTRIAL DR. SE DECISION MADE: 31-OCT-03
ANN ARBOR, MI 48103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIEWPOINT TELEMETRY SYSTEM
DATASCOPE CORP. 510(k) NO: K031760(ABBREVIATED)
ATTN: SUSAN E MANDY PHONE NO : 201-995-8025
800 MACARTHUR BLVD. SE DECISION MADE: 10-OCT-03
MAHWAH, NJ 07430-0619 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 S
DATEX-OHMEDA 510(k) NO: K033078(SPECIAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685
86 PILGRIM RD. SE DECISION MADE: 29-OCT-03
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS
DATEX-OHMEDA, INC. 510(k) NO: K023366(TRADITIONAL)
ATTN: MICHAEL A CHILBERT PHONE NO : 608-221-1551
P.O. BOX 7550 SE DECISION MADE: 07-OCT-03
MADISON, WI 53707 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL AMBULATORY ECG (HOLTER) RECORDER
DATRIX 510(k) NO: K031074(TRADITIONAL)
ATTN: LAUREN M LUHMANN PHONE NO : 760-480-8874
340 STATE PLACE SE DECISION MADE: 15-OCT-03
ESCONDIDO, CA 92029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DBB-05 HEMODIALYSIS DELIVERY SYSTEM
DAVITA CLINICAL RESEARCH (TRRI) 510(k) NO: K023509(TRADITIONAL)
ATTN: TRACY L GRAY PHONE NO : 763-287-3830
4050 OLSON MEMORIAL HWY SE DECISION MADE: 30-OCT-03
MINNEAPOLIS, MN 55422 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT
DENTAURUM 510(k) NO: K032195(TRADITIONAL)
ATTN: JAN A DOORSCHODT PHONE NO : 215-968-2858
10 PHEASANT RUN SE DECISION MADE: 07-OCT-03
NEWTOWN, PA 18940 510(k) STATEMENT
DEVICE: APPOLLO 3 ALLOY
DENTSPLY INTERNATIONAL 510(k) NO: K032320(TRADITIONAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE. SE DECISION MADE: 01-OCT-03
P.O. BOX 872 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17405-0872
DEVICE: CLS-2000 UNIT
DENTSPLY INTL. 510(k) NO: K024133(TRADITIONAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE. SE DECISION MADE: 01-OCT-03
YORK, PA 17405-0872 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUCAM CONCEPT IV FWT, MODEL 110-0185G1
DENTSPLY INTL. 510(k) NO: K032904(SPECIAL)
ATTN: JOHN R MILLER PHONE NO : 847-640-4924
901 W. OAKTON ST. SE DECISION MADE: 14-OCT-03
DES PLAINES, IL 60018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACE NANCY NAIL
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K032687(TRADITIONAL)
ATTN: RHONDA MYER PHONE NO : 574-371-4944
700 ORTHOPAEDIC DR. SE DECISION MADE: 06-OCT-03
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE)
DEROYAL 510(k) NO: K031408(TRADITIONAL)
ATTN: AUDREY DANIELS PHONE NO : 865-362-2091
200 DEBUSK LN. SE DECISION MADE: 15-OCT-03
POWELL, TN 37849 510(k) STATEMENT
DEVICE: IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTA
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K032881(SPECIAL)
ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 10-OCT-03
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL 2100 PULSE OXIMETER
DOLPHIN MEDICAL INC. 510(k) NO: K031465(SPECIAL)
ATTN: JON WERNER PHONE NO : 813-818-7488
13801 MCCORMICK DR. SE DECISION MADE: 10-OCT-03
TAMPA, FL 33626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210
DOLPHIN MEDICAL INC. 510(k) NO: K032947(SPECIAL)
ATTN: BILL CURNAN PHONE NO : 720-348-0389
9433 S. MORNING GLORY LN. SE DECISION MADE: 17-OCT-03
LITTLETON, CO 80130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM
DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K033305(SPECIAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 31-OCT-03
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM
DUCKWORTH & KENT, LTD. 510(k) NO: K024072(TRADITIONAL)
ATTN: MARTIN LOCK PHONE NO : 011 441 462893254
TERENCE HOUSE, 7 MARQUIS SE DECISION MADE: 06-OCT-03
BUSINESS CENTRE ROYSTON RD. 510(k) STATEMENT
BALDOCK, HERTS, UNITED KINGDOM SG7 6XL
DEVICE: DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED
DYNATRONICS CORP. 510(k) NO: K031329(TRADITIONAL)
ATTN: RON HATCH PHONE NO : 801-568-7000
7030 PARK CENTRE DR. SE DECISION MADE: 22-OCT-03
SALT LAKE CITY, UT 84121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI ACUMEN SURGICAL NAVIGATION SYSTEM
EBI, L.P. 510(k) NO: K031732(TRADITIONAL)
ATTN: JON CAPAROTTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 15-OCT-03
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EDWARDS PERIPHERAL DILATATION CATHETER
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K032587(TRADITIONAL)
ATTN: KEVIN DRISKO PHONE NO : 949-250-2416
ONE EDWARDS WAY SE DECISION MADE: 02-OCT-03
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-STRIP
EEMSO, INC. 510(k) NO: K031769(TRADITIONAL)
ATTN: LARRY R PILOT PHONE NO : 202-496-7561
1900 K STREET, NW SE DECISION MADE: 14-OCT-03
WASHINGTON, DC 20006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EKOS PERIPHERAL INFUSION SYSTEM
EKOS CORP. 510(k) NO: K033214(SPECIAL)
ATTN: JOCELYN KERSTEN PHONE NO : 425-482-1108
22030 20TH AVENUE S.E. SE DECISION MADE: 14-OCT-03
SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98021
DEVICE: ELEKTA SYNERGY SYSTEM
ELEKTA ONCOLOGY SYSTEMS, LTD. 510(k) NO: K032996(SPECIAL)
ATTN: PETER STEGAGNO PHONE NO : 770-300-9725
4775 PEACHTREE INDUSTRIAL BLVD SE DECISION MADE: 23-OCT-03
BLDG 300, SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
NORCROSS, GA 30092
DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES
ELITE INTERNATIONAL, INC. 510(k) NO: K032616(TRADITIONAL)
ATTN: BOBBY LING PHONE NO : 800-788-9486
18709 GREENBAY DR. SE DECISION MADE: 02-OCT-03
ROWLAND HEIGHTS, CA 91748 510(k) STATEMENT
DEVICE: EM PROBE, EM PAD
EM PROBE INC. 510(k) NO: K024361(TRADITIONAL)
ATTN: GLEN A GORDON PHONE NO : 360-797-7900
1501 OLD GARDINER RD. SE DECISION MADE: 09-OCT-03
SEQUIM, WA 98382 510(k) STATEMENT
DEVICE: ENDOHELIX ENDARTERECTOMY DEVICE
ENDARX, INC. 510(k) NO: K032105(TRADITIONAL)
ATTN: SCOTT ADAMS PHONE NO : 650-926-9335
3270 ALPINE ROAD SE DECISION MADE: 30-OCT-03
PORTOLA VALLEY, CA 94028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENSITE SYSTEM
ENDOCARDIAL SOLUTIONS, INC. 510(k) NO: K033211(SPECIAL)
ATTN: KAREN J MCKELVEY PHONE NO : 651-632-9454
1350 ENERGY LN., SUITE 110 SE DECISION MADE: 30-OCT-03
ST. PAUL, MN 55108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIEWMATE ULTRASOUND IMAGING SYSTEM
EP MEDSYSTEMS 510(k) NO: K031066(TRADITIONAL)
ATTN: JOHN J TALARICO PHONE NO : 856-753-8533
COOPER RUN EXECUTIVE PARK SE DECISION MADE: 17-OCT-03
575 ROUTE 73 N. BLDG. D 510(k) STATEMENT
WEST BERLIN, NJ 08091
DEVICE: ESSEX HIGH PRESSURE (HP) OCD AND ESSEX ESCORT PNEUMATIC CONSERVE
ESSEX MEDICAL SYSTEMS PLUS 510(k) NO: K024023(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD. SE DECISION MADE: 01-OCT-03
SUITE 200 510(k) STATEMENT
GREAT NECK, NY 11021
DEVICE: REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH
ESTECH, INC. 510(k) NO: K032632(ABBREVIATED)
ATTN: ARTHUR BERTOLERO PHONE NO : 925-648-3500
4135 BLACKHAWK PLAZA CIRCLE SE DECISION MADE: 22-OCT-03
#150 510(k) SUMMARY AVAILABLE FROM FDA
DANVILLE, CA 94506
DEVICE: CAP BONE SUBSTITUTE MATERIAL
ETEX CORP. 510(k) NO: K032307(TRADITIONAL)
ATTN: KRISTINE CANAVAN PHONE NO : 617-577-7270
UNIVERSITY PARK AT MIT SE DECISION MADE: 24-OCT-03
38 SIDNEY STREET 510(k) SUMMARY AVAILABLE FROM FDA
CAMBRIDGE, MA 02139
DEVICE: MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYS
ETHICON ENDO-SURGERY, INC. 510(k) NO: K030472(TRADITIONAL)
ATTN: MICHAEL J CRADER PHONE NO : 513-337-8581
4545 CREEK RD. SE DECISION MADE: 09-OCT-03
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOPATH BLADELESS TROCAR, ENDOPATH BLUNT TIP TROCAR, ENDOPATH D
ETHICON ENDO-SURGERY, INC. 510(k) NO: K032676(TRADITIONAL)
ATTN: ELIZABETH MILLER PHONE NO : 513-337-7146
4545 CREEK RD. SE DECISION MADE: 30-OCT-03
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNT
ETHICON, INC. 510(k) NO: K032420(TRADITIONAL)
ATTN: REY LIBROJO PHONE NO : 908-218-3198
ROUTE 22 WEST SE DECISION MADE: 22-OCT-03
SOMERVILLE, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUF-COVER (TM)
ETHOX CORP. 510(k) NO: K031195(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 10-OCT-03
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL A
EUROSURGICAL S.A. 510(k) NO: K031471(TRADITIONAL)
ATTN: KAREN E WARDEN PHONE NO : 304-598-0525
7000 HAMPTON CENTER SE DECISION MADE: 10-OCT-03
SUITE G1 510(k) SUMMARY AVAILABLE FROM FDA
MORGANTOWN, WV 26505
DEVICE: PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
EV3 INC 510(k) NO: K032580(SPECIAL)
ATTN: GLEN D SMYTHE PHONE NO : 763-398-7391
4600 NATHAN LN. NORTH SE DECISION MADE: 22-OCT-03
PLYMOUTH, MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P
EVERYWAY MEDICAL INSTRUMENTS CO., 510(k) NO: K033140(SPECIAL)
ATTN: JAY MANSOR PHONE NO : 770-777-4146
1308 MORNINGSIDE PARK DR. SE DECISION MADE: 29-OCT-03
ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSIGHT MILLENNIUM III
FASSTECH 510(k) NO: K023209(TRADITIONAL)
ATTN: LEE BRODY PHONE NO : 978-663-2800
76 TREBLE COVE RD. SE DECISION MADE: 10-OCT-03
BUILDING #2 510(k) SUMMARY AVAILABLE FROM FDA
NORTH BILLERICA, MA 01862
DEVICE: FERRIS POLYMEM SILVER WOUND DRESSING
FERRIS MFG. CORP. 510(k) NO: K031307(TRADITIONAL)
ATTN: THEODORE THORSEN PHONE NO : 630-734-7830
16W300 83RD ST. SE DECISION MADE: 22-OCT-03
BURR RIDGE, IL 60527-5848 510(k) STATEMENT
DEVICE: FINOMETER NONINVASIVE HEMODYNAMIC MONITOR, MODEL 1
FMS, FINAPRES MEDICAL SYSTEMS BV 510(k) NO: K023723(TRADITIONAL)
ATTN: CHRISTINE EMANUEL PHONE NO : 805-963-4312
1205 DE LA VINA ST. SE DECISION MADE: 23-OCT-03
SANTA BARBARA, CA 93101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M
FOCUS TECHNOLOGIES, INC. 510(k) NO: K031952(TRADITIONAL)
ATTN: MICHAEL J WAGNER PHONE NO : 714-220-1900
10703 PROGRESS WAY SE DECISION MADE: 22-OCT-03
CYPRESS, CA 90630-4737 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WEST NILE VIRUS ELISA IGG, MODEL EL0300G
FOCUS TECHNOLOGIES, INC. 510(k) NO: K031953(TRADITIONAL)
ATTN: MICHAEL J WAGNER PHONE NO : 714-220-1900
10703 PROGRESS WAY SE DECISION MADE: 22-OCT-03
CYPRESS, CA 90630-4737 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XIVE TG ABUTMENTS
FRIADENT GMBH 510(k) NO: K032302(TRADITIONAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900
21911 ERIE LN. SE DECISION MADE: 02-OCT-03
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE
FRIANDENT GMBH 510(k) NO: K032750(SPECIAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900
21911 ERIE LN. SE DECISION MADE: 02-OCT-03
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUKUDA DENSHI DYNASCOPE MODEL DS-7100 SERIES PORTABLE PATIENT MO
FUKUDA DENSHI USA, INC. 510(k) NO: K032290(SPECIAL)
ATTN: LARRY D WALKER PHONE NO : 425-881-7737
17725 N.E. 65TH ST., BLDG. C SE DECISION MADE: 10-OCT-03
REDMOND, WA 98052-4911 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUKUDA DENSHI MODEL FF SONIC UF-750XT
FUKUDA DENSHI USA, INC. 510(k) NO: K033209(TRADITIONAL)
ATTN: LARRY D WALKER PHONE NO : 800-365-6668
17725 NE 65TH STREET SE DECISION MADE: 31-OCT-03
BUILDING C 510(k) SUMMARY AVAILABLE FROM FDA
REDMOND, WA 98052
DEVICE: FIT CHECKER II
GC AMERICA, INC. 510(k) NO: K032289(TRADITIONAL)
ATTN: TERRY L JORITZ PHONE NO : 708-926-3105
3737 WEST 127TH ST. SE DECISION MADE: 20-OCT-03
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X
GE MED. SYSTEMS ULTRASOUND & PRIM.510(k) NO: K032656(SPECIAL)
ATTN: ALLEN SCHUH PHONE NO : 414-647-4385
4855 WEST ELECTRIC AVE. SE DECISION MADE: 30-OCT-03
WEST MILWAUKEE, WI 53219 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T-WAVE ALTERNANS (TWA) ALGORITHM OPTION
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K032513(TRADITIONAL)
ATTN: DAVID WAHLIG PHONE NO : 262-293-1705
8200 WEST TOWER AVE. SE DECISION MADE: 30-OCT-03
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K032577(TRADITIONAL)
ATTN: LISA L MICHELS PHONE NO : 262-293-1609
8200 WEST TOWER AVE. SE DECISION MADE: 10-OCT-03
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT
GE MEDICAL SYSTEMS, INC. 510(k) NO: K033244(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
3000 N. GRANDVIEW BLVD. SE DECISION MADE: 16-OCT-03
MAIL STOP W-400 510(k) SUMMARY AVAILABLE FROM FDA
WAUKESHA, WI 53188 THIRD PARTY REVIEW
DEVICE: GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM
GE MEDICAL SYSTEMS, LLC 510(k) NO: K032795(SPECIAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
3200 N. GRANDVIEW BLVD. SE DECISION MADE: 08-OCT-03
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANTAGE 4D OPTION
GE MEDICAL SYSTEMS, LLC 510(k) NO: K032915(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
3000 N GRANDVIEW BLVD. SE DECISION MADE: 30-OCT-03
W-400 510(k) SUMMARY AVAILABLE FROM FDA
WAUKESHA, WI 53188 THIRD PARTY REVIEW
DEVICE: GE LOGIQ BOOK
GENERAL ELECTRIC CO. 510(k) NO: K032477(TRADITIONAL)
ATTN: ALLEN SCHUH PHONE NO : 414-647-4385
P.O. BOX 414 SE DECISION MADE: 22-OCT-03
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE VOLUSON 730 PRO/EXPERT BT03 ULTRASOUND SYSTEM
GENERAL ELECTRIC CO. 510(k) NO: K032620(SPECIAL)
ATTN: ALLEN SCHUH PHONE NO : 414-647-4385
P.O. BOX 414 SE DECISION MADE: 10-OCT-03
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE LOGIQ 5 PRO OR EXPERT
GENERAL ELECTRIC CO. 510(k) NO: K032974(SPECIAL)
ATTN: ALLEN SCHUH PHONE NO : 414-647-4385
4855 WESTELECTRIC AVENUE SE DECISION MADE: 21-OCT-03
PO BOX 414 510(k) SUMMARY AVAILABLE FROM FDA
MILWAUKEE, WI 53219
DEVICE: GE MARLIN ULTRASOUND
GENERAL ELECTRIC CO. 510(k) NO: K033139(SPECIAL)
ATTN: ALLEN SCHUH PHONE NO : 414-647-4385
P.O. BOX 414 SE DECISION MADE: 23-OCT-03
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE 0.2T SIGNA PROFILE/I MR SYSTEM
GENERAL ELECTRIC CO. 510(k) NO: K033168(SPECIAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
P.O. BOX 414 SE DECISION MADE: 10-OCT-03
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FERTELL FEMALE FERTILITY TEST
GENOSIS, INC. 510(k) NO: K032002(TRADITIONAL)
ATTN: SHARON A SEGAL PHONE NO : 202-739-5427
1111 PENNSYLVANIA AVE,NW SE DECISION MADE: 30-OCT-03
WASHINGTON,, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOSIGN STEAM-24 BIOLOGICAL INDICATOR
GETINGE USA, INC 510(k) NO: K032723(SPECIAL)
ATTN: KARLA BYRNE PHONE NO : 585-272-5007
1777 EAST HENRIETTA RD. SE DECISION MADE: 01-OCT-03
ROCHESTER, NY 14623-3133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GIVEN DIAGNOSTIC SYSTEM
GIVEN IMAGING LTD. 510(k) NO: K032405(TRADITIONAL)
ATTN: SHOSHANA FRIEDMAN PHONE NO : 972 4 9097784
13 HAYETZIRA STREET SE DECISION MADE: 29-OCT-03
NEW INDUSTRIAL ZONE 510(k) SUMMARY AVAILABLE FROM FDA
YOKNEAM, ISRAEL 20692
DEVICE: GLOBAL PRESS-FIT STEM
GLOBAL MEDICAL CO. 510(k) NO: K032385(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 30-OCT-03
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER
GONOTEC GESELLSCHAFT FUER MESS-UND510(k) NO: K032608(ABBREVIATED)
ATTN: THOMAS BOCK PHONE NO : 011 490 3091208594
SCHOENHAUSER STRASSE 73C SE DECISION MADE: 21-OCT-03
BERLIN, GERMANY 13158 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JABES ELECTRONIC STETHOSCOPE
GS TECHNOLOGY CO., LTD. 510(k) NO: K031446(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 31-OCT-03
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO OMNILINK .035 BILIARY STENT SYSTEM
GUIDANT CORPORATION 510(k) NO: K032530(SPECIAL)
ATTN: MICHELLE GROSSMAN PHONE NO : 650-470-6372
1525 O'BRIEN DR. SE DECISION MADE: 23-OCT-03
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPHAEL
HAMILTON MEDICAL AG 510(k) NO: K022679(TRADITIONAL)
ATTN: DAVID THOMPSON PHONE NO : 775-858-3200
P.O. BOX 30008 (89520) SE DECISION MADE: 22-OCT-03
4990 ENERGY WAY 510(k) SUMMARY AVAILABLE FROM FDA
RENO, NV 89502
DEVICE: DISTAL RADIUS FRACTURE REPAIR SYSTEM
HAND INNOVATIONS, INC. 510(k) NO: K032705(SPECIAL)
ATTN: AL WEISENBORN PHONE NO : 305-829-3437
8905 SW 87TH AVENUE SE DECISION MADE: 01-OCT-03
SUITE 220 510(k) SUMMARY AVAILABLE FROM FDA
MIAMI, FL 33176
DEVICE: HANDIVIPP
HANDINOR USA, INC. 510(k) NO: K033125(TRADITIONAL)
ATTN: BARBARA CHIPONIS PHONE NO : 763-404-9396
17610 26TH AVE. NORTH SE DECISION MADE: 30-OCT-03
PLYMOUTH, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR)
HARRY J. BOSWORTH CO. 510(k) NO: K031439(TRADITIONAL)
ATTN: MILDRED M GOLDSTEIN PHONE NO : 847-679-3400
7227 NORTH HAMLIN AVE. SE DECISION MADE: 02-OCT-03
SKOKIE, IL 60076 510(k) STATEMENT
DEVICE: HL888BF
HEALTH & LIFE CO., LTD. 510(k) NO: K032695(SPECIAL)
ATTN: PAUL HUNG PHONE NO : 886 282 271300
9F, NO.186, JIAN YI ROAD SE DECISION MADE: 02-OCT-03
CHUNG HO CITY, TAIPEI, CHINA (TAIW510(k) STATEMENT
DEVICE: HL888BM
HEALTH & LIFE CO., LTD. 510(k) NO: K032837(SPECIAL)
ATTN: PAUL HUNG PHONE NO : 886 2 82271300
9F, NO.186, JIAN YI ROAD SE DECISION MADE: 10-OCT-03
CHUNG HO CITY, TAIPEI, CHINA (TAIW510(k) STATEMENT
DEVICE: HL888BA
HEALTH & LIFE CO., LTD. 510(k) NO: K032839(SPECIAL)
ATTN: PAUL HUNG PHONE NO : 886 2 82271300
9F, NO.186, JIAN YI ROAD SE DECISION MADE: 10-OCT-03
CHUNG HO CITY, TAIPEI, CHINA (TAIW510(k) STATEMENT
DEVICE: HL888 AF
HEALTH & LIFE CO., LTD. 510(k) NO: K032913(SPECIAL)
ATTN: PAUL HUNG PHONE NO : 886 282 271300
9F, NO.186, JIAN YI ROAD SE DECISION MADE: 02-OCT-03
CHUNG HO CITY, TAIPEI, CHINA (TAIW510(k) STATEMENT
DEVICE: MODIFICATION TO HL168
HEALTH & LIFE CO., LTD. 510(k) NO: K033043(SPECIAL)
ATTN: PAUL HUNG PHONE NO : 886 2 82271300
9F, NO.186, JIAN YI ROAD SE DECISION MADE: 10-OCT-03
CHUNG HO CITY, TAIPEI, CHINA (TAIW510(k) STATEMENT
DEVICE: MEDRELIEF SE SERIES, MODELS SE-50, SE-100, SE-200, SE-300
HEALTHONICS, INC. 510(k) NO: K030998(TRADITIONAL)
ATTN: JAMES W KRONBERG PHONE NO : 803-652-2354
903 MAIN ST. SOUTH SE DECISION MADE: 10-OCT-03
NEW ELLENTON, SC 29809 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMEDEX CRANIAL BOLT MODELS, 3601, 3602
HEMEDEX INCORPORATED 510(k) NO: K032337(TRADITIONAL)
ATTN: DEBBIE IAMPIETRO PHONE NO : 508-435-9893
7 TIFFANY TRAIL SE DECISION MADE: 21-OCT-03
HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT S
HILL-ROM MANUFACTURING, INC. 510(k) NO: K032772(SPECIAL)
ATTN: CINDY L CROSBY PHONE NO : 919-854-3217
1225 CRESCENT GREEN SE DECISION MADE: 08-OCT-03
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
CARY, NC 27511
DEVICE: HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K033248(TRADITIONAL)
ATTN: DOUG THISTLETHWAITE PHONE NO : 330-425-1313
1959 SUMMIT COMMERCE PARK SE DECISION MADE: 20-OCT-03
TWINSBURG, OH 44087-2371 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM
HMD BIOMEDICAL, INC. 510(k) NO: K032985(SPECIAL)
ATTN: JEFFREY FLEISHMAN PHONE NO : 732-918-0770
3505 SUNSET AVE. SE DECISION MADE: 21-OCT-03
OCEAN, NJ 07712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOLOGIC DR IMAGEPRO
HOLOGIC, INC. 510(k) NO: K032546(TRADITIONAL)
ATTN: DANIEL F PHELAN PHONE NO : 781-999-7300
35 CROSBY DR. SE DECISION MADE: 16-OCT-03
BEDFORD, MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-329M S
HOME CARE TECHNOLOGY CO., LTD. 510(k) NO: K023000(TRADITIONAL)
ATTN: SHU-CHEN CHENG PHONE NO : 614-451-1918
2064 TAMARIN DR. SE DECISION MADE: 29-OCT-03
COLUMBUS, OH 43235 510(k) STATEMENT
DEVICE: ACCOLADE-J HIP STEM SERIES
HOWMEDICA OSTEONICS CORP. 510(k) NO: K032300(TRADITIONAL)
ATTN: LORRAINE MONTEMURRO PHONE NO : 201-831-5892
59 ROUTE 17 SE DECISION MADE: 09-OCT-03
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T2 NAILING SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K032523(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581
59 ROUTE 17 SE DECISION MADE: 22-OCT-03
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLOBAL MODULAR REPLACEMENT SYSTEM ANTEVERTED PROMIMAL FEMORAL CO
HOWMEDICA OSTEONICS CORP. 510(k) NO: K032581(TRADITIONAL)
ATTN: MARGARET F CROWE PHONE NO : 201-831-5580
59 ROUTE 17 SE DECISION MADE: 09-OCT-03
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T2 RECON NAIL SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K032898(SPECIAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581
59 ROUTE 17 SOUTH SE DECISION MADE: 09-OCT-03
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKER
I-STAT CORPORATION 510(k) NO: K031873(TRADITIONAL)
ATTN: GREGORY W SHIPP PHONE NO : 609-443-9300
104 WINDSOR CENTER DR. SE DECISION MADE: 07-OCT-03
EAST WINDSOR, NJ 08520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHOENCODER
ICARDIOGRAM, INCORPORATED 510(k) NO: K032324(TRADITIONAL)
ATTN: JAMES LOEHR PHONE NO : 919-534-2150
100 EAST SIX FORKS ROAD, SE DECISION MADE: 02-OCT-03
SUITE 305 510(k) SUMMARY AVAILABLE FROM FDA
RALIEGH, NC 27609
DEVICE: CENTRA VIEW DEVICE LINK SYSTEM
ICU DATASYSTEMS, INC. 510(k) NO: K033283(TRADITIONAL)
ATTN: SAMUEL W COONS PHONE NO : 352-692-5585
2153 SE HAWTHORNE ROAD SE DECISION MADE: 27-OCT-03
SUITE 220 510(k) SUMMARY AVAILABLE FROM FDA
GAINESVILLE, FL 32641 THIRD PARTY REVIEW
DEVICE: THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330
IMPLEX CORP. 510(k) NO: K032344(SPECIAL)
ATTN: MARCI HALEVI PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 02-OCT-03
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEDROCEL VERTEBRAL BODY REPLACEMENT
IMPLEX CORP. 510(k) NO: K032527(SPECIAL)
ATTN: MARCI HALEVI PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 31-OCT-03
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INION CPS BABY 1.5 BIOABSORBABLE SYSTEM
INION LTD. 510(k) NO: K033194(SPECIAL)
ATTN: HANNA MARTTILA PHONE NO : 358 323 06600
LAAKARINKATU 2 SE DECISION MADE: 30-OCT-03
TAMPERE, FINLAND 33520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CSF400 AND CSF600
INMED LTDA. 510(k) NO: K030081(TRADITIONAL)
ATTN: JAY MANSOUR PHONE NO : 678-908-8180
1308 MORNINGSIDE PARK DR. SE DECISION MADE: 06-OCT-03
ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 5.0 X 5MM ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM
INNOVA LIFE SCIENCES CORP. 510(k) NO: K032140(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813
555 13TH ST. N.W. SE DECISION MADE: 02-OCT-03
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INNOVATECH STRAIGHT LASER PROBE, MODEL 420-10
INNOVATECH SURGICAL INC. 510(k) NO: K032703(TRADITIONAL)
ATTN: MICHAEL J MCGOWAN PHONE NO : 800-240-3123
1000 ATLANTIC AVENUE SE DECISION MADE: 24-OCT-03
SUITE 514 510(k) SUMMARY AVAILABLE FROM FDA
CAMDEN, NJ 08104
DEVICE: INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-30
INNOVATECH SURGICAL INC. 510(k) NO: K032704(TRADITIONAL)
ATTN: MICHAEL J MCGOWAN PHONE NO : 800-240-3123
1000 ATLANTIC AVENUE SE DECISION MADE: 24-OCT-03
SUITE 514 510(k) SUMMARY AVAILABLE FROM FDA
CAMDEN, NJ 08104
DEVICE: AUDICOR UPGRADE SYSTEM
INOVISE MEDICAL, INC. 510(k) NO: K032145(TRADITIONAL)
ATTN: STEVE HESLER PHONE NO : 503-554-4291
1025 INDUSTRIAL PKWY. SE DECISION MADE: 31-OCT-03
SUITE C 510(k) SUMMARY AVAILABLE FROM FDA
NEWBERG, OR 97132
DEVICE: QUANTEX D-DIMER
INSTRUMENTATION LABORATORY CO. 510(k) NO: K032419(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 24-OCT-03
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXTERNAL DRAINAGE SET
INTEGRA NEUROSCIENCES IMPLANTS S.A510(k) NO: K032817(SPECIAL)
ATTN: JUDITH E O'GRADY PHONE NO : 609-936-2311
311 ENTERPRISE DRIVE SE DECISION MADE: 06-OCT-03
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTELEPACS
INTELERAD MEDICAL SYSTEMS INC. 510(k) NO: K032533(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1100 LAKEVIEW BLVD. SE DECISION MADE: 16-OCT-03
DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTER-OS LIMB LENGTHENER
INTER-OS TECHNOLOGIES 510(k) NO: K031875(TRADITIONAL)
ATTN: RANDOLPH C ROBINSON PHONE NO : 303-708-8390
7430 E, PARK MEADOWS DRIVE SE DECISION MADE: 22-OCT-03
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
LONE TREE, CO 80124
DEVICE: RATIONAL IMAGING PACS
INTUITIVE IMAGING INFORMATICS, LLC510(k) NO: K031473(TRADITIONAL)
ATTN: DONALD MUNDT PHONE NO : 818-347-8919
30 HACKAMORE LN., SUITE 4 SE DECISION MADE: 30-OCT-03
BELL CANYON, CA 91307 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: US-100 PORTABLE ULTRASOUND THERAPY UNIT
ITO CO., LTD. 510(k) NO: K032793(TRADITIONAL)
ATTN: T. WHIT ATHEY PHONE NO : 301-570-0013
2305 GOLD MINE RD. SE DECISION MADE: 09-OCT-03
BROOKEVILLE, MD 20833 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIVASENS
IVOCLAR VIVADENT, INC. 510(k) NO: K030922(TRADITIONAL)
ATTN: DONNA MARIE HARTNETT PHONE NO : 716-691-2260
175 PINEVIEW DR. SE DECISION MADE: 17-OCT-03
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: VISTAKON (GALYFILCON A) SOFT CONTACT LENS
JOHNSON & JOHNSON VISION CARE, INC510(k) NO: K032340(TRADITIONAL)
ATTN: JACQUELINE ZIMOVAN PHONE NO : 904-443-1402
7500 CENTURION PARKWAY, SE DECISION MADE: 16-OCT-03
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32256
DEVICE: JS VASCULAR GUIDE WIRE VISE/TORQUE DEVICE
JS VASCULAR, INC. 510(k) NO: K032411(TRADITIONAL)
ATTN: MICHAEL A DANIEL PHONE NO : 925-254-5228
8 SNOWBERRY COURT SE DECISION MADE: 07-OCT-03
ORINDA, CA 94563 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KAVO EVEREST ZH-BLANK
KAVO AMERICA CORPORATION 510(k) NO: K033221(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 28-OCT-03
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE
KIMBERLY-CLARK CORP. 510(k) NO: K031750(TRADITIONAL)
ATTN: RICHARD V WOLFE PHONE NO : 770-587-8208
1400 HOLCOMB BRIDGE RD. SE DECISION MADE: 24-OCT-03
ROSWELL, GA 30076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISO-ELASTIC CERCLAGE SYSTEM
KINAMED, INC. 510(k) NO: K030256(TRADITIONAL)
ATTN: VINEET SARIN PHONE NO : 805-384-2748
820 FLYNN RD. SE DECISION MADE: 21-OCT-03
CAMARILLO, CA 93012 510(k) STATEMENT
DEVICE: MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS
KINETIC CONCEPTS, INC. 510(k) NO: K032310(TRADITIONAL)
ATTN: JUDITH HARBOUR PHONE NO : 210-255-4468
P.O. BOX 659508 SE DECISION MADE: 10-OCT-03
SAN ANTONIO, TX 78216-9508 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE POWDER FREE VINYL EXAM GLOVES
KINGSWELL INTERNATIONAL INC. 510(k) NO: K032630(TRADITIONAL)
ATTN: D.C. CHANG PHONE NO : 909-465-5769
264 CARBONIA AVE. SE DECISION MADE: 03-OCT-03
WALNUT, CA 91789 510(k) STATEMENT
DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES
KINGSWELL INTERNATIONAL INC. 510(k) NO: K032668(TRADITIONAL)
ATTN: D.C. CHANG PHONE NO : 909-465-5769
264 CARBONIA AVE. SE DECISION MADE: 07-OCT-03
WALNUT, CA 91789 510(k) STATEMENT
DEVICE: KLS-MARTIN STERNAL PLATING SYSTEM
KLS-MARTIN L.P. 510(k) NO: K032413(TRADITIONAL)
ATTN: JENNIFER DAMATO PHONE NO : 904-641-7746
11239-1 ST. JOHN'S IND. PKWY. SE DECISION MADE: 10-OCT-03
SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32246
DEVICE: KLS-MARTIN MANDIBULAR/RECONSTRUCTION SYSTEM II
KLS-MARTIN L.P. 510(k) NO: K032442(TRADITIONAL)
ATTN: JENNIFER DAMATO PHONE NO : 904-641-7746
11239-1 ST. JOHN'S IND. PKWY. SE DECISION MADE: 29-OCT-03
SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32246
DEVICE: KD-622 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
KONDON (TIANJIN) ELECTRONIC & ELEC510(k) NO: K030358(TRADITIONAL)
ATTN: LIU YI PHONE NO : 86 22 27470070
NO. 31 CHANGJIANG ROAD SE DECISION MADE: 31-OCT-03
NANKAI DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
TIANJIN, CHINA 300193
DEVICE: LALAN GLOVES (PVT) LTD GLOVE, PATIENT EXAMINATION, LATEX
LALAN GLOVES (PVT) LTD. 510(k) NO: K031386(TRADITIONAL)
ATTN: UPUL GUNASINGHE PHONE NO : 009 414 65802
BLOCK B, BEPZ SE DECISION MADE: 06-OCT-03
BIYAGAMA, SRI LANKA 510(k) STATEMENT
DEVICE: AQUABOSS ECORO DIA 50
LAUER LTD., HONG KONG 510(k) NO: K032004(TRADITIONAL)
ATTN: STEPHAN KRIETEMEYER PHONE NO : 497 621 927015
SPEICHERMATT 9 SE DECISION MADE: 02-OCT-03
WITTLINGEN, GERMANY 79599 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (50
LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K031797(TRADITIONAL)
ATTN: CHENG-I LIN PHONE NO : 408-732-3856
687 NORTH PASTORIA AVE. SE DECISION MADE: 10-OCT-03
SUNNYVALE, CA 94085-2917 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221
LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K032461(TRADITIONAL)
ATTN: CHENG I LIN PHONE NO : 408-732-3856
687 NORTH PASTORIA AVE. SE DECISION MADE: 03-OCT-03
SUNNYVALE, CA 94085-2917 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BROTHERS POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YE
LONG FIRST (XIAMEN) PLASTICS CO., 510(k) NO: K032323(TRADITIONAL)
ATTN: CHIEN LIN PHONE NO : 773-327-2054
2631 N. MAGNOLIA STREET SE DECISION MADE: 07-OCT-03
CHICAGO, IL 60614 510(k) STATEMENT
DEVICE: NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES
LUMENIS, INC. 510(k) NO: K032357(TRADITIONAL)
ATTN: KAREN BAKER PHONE NO : 408-764-3603
2400 CONDENSA ST. SE DECISION MADE: 09-OCT-03
SANTA CLARA, CA 95051-0901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDICARE MODEL MT-301F & MT-301C
LUMISCOPE CO., INC. 510(k) NO: K032714(TRADITIONAL)
ATTN: MARIO MANZANO PHONE NO : 732-254-3800
122 TICES LN. SE DECISION MADE: 22-OCT-03
EAST BRUNSWICK, NJ 08816 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY E
MAHE INTL., INC. 510(k) NO: K030857(TRADITIONAL)
ATTN: PAUL CART PHONE NO : 615-269-7256
490 CRAIGHEAD SE DECISION MADE: 16-OCT-03
NASHVILLE, TN 37204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAXTER STERILE POWDER FREE SURGICAL GLOVES
MAXTER GLOVE MANUFACTURING SDN BHD510(k) NO: K032501(TRADITIONAL)
ATTN: STANLEY THAI PHONE NO : 603 339 23328
LOT 6070, JALAN HAJI ABDUL SE DECISION MADE: 17-OCT-03
MANAN, 6TH MILES OFF JALAN 510(k) STATEMENT
MERU, KLANG, SELANGOR, MALAYSIA 41050
DEVICE: MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE K
MCKINLEY, INC. 510(k) NO: K033039(SPECIAL)
ATTN: ANDREW N LAMBORNE PHONE NO : 303-420-9569
4080 YOUNGFIELD ST. SE DECISION MADE: 07-OCT-03
WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMBLA N7000
MEDCARE FLAGA 510(k) NO: K024322(TRADITIONAL)
ATTN: KUMAR KULKARNI PHONE NO : 269-968-3855
46 LOCH HAVEN LN. SE DECISION MADE: 27-OCT-03
BATTLE CREEK, MI 49015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDELA CLARIO HOME CARE PUMP
MEDELA AG 510(k) NO: K033179(ABBREVIATED)
ATTN: WERNER FREI PHONE NO : 414 176 95151 EXT2
LAETTICHSTRASSE 4 SE DECISION MADE: 15-OCT-03
CH-6340 BAAR, SWITZERLAND 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MAS PAR TDM
MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K032826(TRADITIONAL)
ATTN: PENNY M LAYMAN PHONE NO : 805-987-7891
5300 ADOLFO RD. SE DECISION MADE: 09-OCT-03
CAMARILLO, CA 93012 510(k) STATEMENT
DEVICE: MEDS-4-INF+
MEDICAL EQUIPMENT DEVICE SPECIALIS510(k) NO: K032055(TRADITIONAL)
ATTN: C. A. TEKLINSKI PHONE NO : 619-665-4912
9811 W. CHARLESTON #2387 SE DECISION MADE: 03-OCT-03
LAS VEGAS, NV 89117 510(k) STATEMENT
DEVICE: MEDICAL LASER TECHNOLOGIES, LLC MTL ERBIUM:YAG LASER SYSTEM
MEDICAL LASER TECHNOLOGIES, LLC 510(k) NO: K032599(TRADITIONAL)
ATTN: MARK ROHRER PHONE NO : 205-290-8251
516 SCOTT STREET SE DECISION MADE: 29-OCT-03
HOMEWOOD, AL 35209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CSS
MEDICAL SCIENTIFIC, INC. 510(k) NO: K031564(SPECIAL)
ATTN: PAUL NARDELLA PHONE NO : 508-880-7313
125 JOHN HANCOCK RD. SE DECISION MADE: 07-OCT-03
TAUNTON, MA 02780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDI-HEAT INFANT HEEL WARMER
MEDIHEAT, INC. 510(k) NO: K032989(TRADITIONAL)
ATTN: UMA RAMACHANDRAN PHONE NO : 706-226-1800
505 HILL ROAD SE DECISION MADE: 22-OCT-03
DALTON, GA 30722 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC, INC. RACER BILIARY STENT SYSTEM ("RACER"), MODEL XD#Y
MEDTRONIC AVE, INC. 510(k) NO: K032768(SPECIAL)
ATTN: SARAH SHEPHARD PHONE NO : 707-591-7465
3576 UNOCAL PLACE SE DECISION MADE: 09-OCT-03
SANTA ROSA, CA 95403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333
MEDTRONIC MINIMED 510(k) NO: K032164(TRADITIONAL)
ATTN: GERDA P RESCH PHONE NO : 818-362-5958
18000 DEVONSHIRE ST. SE DECISION MADE: 23-OCT-03
NORTHRIDGE, CA 91325-1219 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC MINIMED PARADIGM COUNTACH INFUSION SET, MODEL MMT 310
MEDTRONIC MINIMED 510(k) NO: K032484(TRADITIONAL)
ATTN: MIRIELLE MENGOTTO PHONE NO : 818-576-4112
18000 DEVONSHIRE ST. SE DECISION MADE: 28-OCT-03
NORTHRIDGE, CA 91325-1219 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC MINIMED COUNTACH INFUSION SET, MODEL 313
MEDTRONIC MINIMED 510(k) NO: K032485(TRADITIONAL)
ATTN: MIRIELLE MENGOTTO PHONE NO : 818-576-4112
18000 DEVONSHIRE ST. SE DECISION MADE: 28-OCT-03
NORTHRIDGE, CA 91325-1219 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL
MEDTRONIC NEUROLOGICAL 510(k) NO: K033016(TRADITIONAL)
ATTN: PAM SCHAUB PHONE NO : 787-847-8817
710 MEDTRONIC PARKWAY, LN145 SE DECISION MADE: 30-OCT-03
MINNEAPOLIS, MN 55432-5604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SUR
MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K033264(SPECIAL)
ATTN: PREETI JAIN PHONE NO : 763-391-9000
7611 NORTHLAND DR. SE DECISION MADE: 31-OCT-03
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC S
MEDTRONIC, INC. 510(k) NO: K032138(TRADITIONAL)
ATTN: DEBORAH KIDDER PHONE NO : 763-514-9463
4000 LEXINGTON AVE., NORTH SE DECISION MADE: 09-OCT-03
SHOREVIEW, MN 55126-2893 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATTAIN 6226DEF DEFLECTABLE CATHETER DELIVERY SYSTEM
MEDTRONIC, INC. 510(k) NO: K032312(SPECIAL)
ATTN: KRISTINA MOLLNER PHONE NO : 763-514-4189
7000 CENTRAL AVENUE N. SE DECISION MADE: 21-OCT-03
FRIDLEY, MN 55432-3576 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EKG SPEAKS
MEDTRONIC, INC. 510(k) NO: K032926(SPECIAL)
ATTN: KRISTYN BENSON PHONE NO : 763-514-4617
7000 CENTRAL AVE. NE SE DECISION MADE: 15-OCT-03
MINNEAPOLIS, MN 55432-3576 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDX1100 CONSOLE & MEDX 100T AND DUOLIGHT LASER ACCESSORIES, MED
MEDX ELECTRONICS, INC. 510(k) NO: K032231(TRADITIONAL)
ATTN: ANITA SALTMARCHE PHONE NO : 888 363 3112
3535 LAIRD ROAD SE DECISION MADE: 03-OCT-03
UNIT 2 510(k) SUMMARY AVAILABLE FROM FDA
MISSISSAUGA, CANADA L5L 5Y7
DEVICE: MODIFICATION TO: HORIZON 9000WS
MENNEN MEDICAL LTD. 510(k) NO: K032997(SPECIAL)
ATTN: ASHER KASSEL PHONE NO :
4 HAYARDEN ST. SE DECISION MADE: 15-OCT-03
P.O. BOX 102 510(k) SUMMARY AVAILABLE FROM FDA
YAVNE, ISRAEL 81228
DEVICE: MERCATOR HEALTHCARE MALE LATEX CONDOM
MERCATOR HEALTHCARE LTD. 510(k) NO: K031369(ABBREVIATED)
ATTN: ELI J CARTER PHONE NO : 919-544-4098
1219 LITTLE CREEK RD. SE DECISION MADE: 31-OCT-03
DURHAM, NC 27713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM
MERIDAN MEDICAL 510(k) NO: K032427(TRADITIONAL)
ATTN: GREG HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 09-OCT-03
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K031922(SPECIAL)
ATTN: JOHN W NICHOLSON PHONE NO : 801-253-2600
1600 WEST MERIT PKWY. SE DECISION MADE: 01-OCT-03
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FIL
META BIOMED CO., LTD. 510(k) NO: K032603(TRADITIONAL)
ATTN: JENNY SHON PHONE NO : 718-639-7460
41-19, 77TH STREET SE DECISION MADE: 07-OCT-03
ELMHURST, NY 11373 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT C
META BIOMED CO., LTD. 510(k) NO: K032605(TRADITIONAL)
ATTN: JENNY SHON PHONE NO : 718-639-7460
41-19, 77TH STREET SE DECISION MADE: 08-OCT-03
ELMHURST, NY 11373 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: S21 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
MICRO CURRENT TECHNOLOGY, INC. 510(k) NO: K033253(TRADITIONAL)
ATTN: DAVID SUZUKI PHONE NO : 206-938-5800
4822 CALIFORNIA AVE., S.W. SE DECISION MADE: 21-OCT-03
SEATTLE, WA 98116 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: MICROGENICS CYCLOSPORINE CONTROL KIT
MICROGENICS CORP. 510(k) NO: K032842(TRADITIONAL)
ATTN: DAVID CASAL PHONE NO : 510-979-5012
46360 FREMONT BLVD. SE DECISION MADE: 17-OCT-03
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
MICROVENTION, INC. 510(k) NO: K032590(TRADITIONAL)
ATTN: VINCENT CUTARELLI PHONE NO : 949-768-1184
75 COLUMBIA SE DECISION MADE: 22-OCT-03
ALISO VIEJO, CA 92656-1408 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMASSAGE ENERGY PRODUCT, MODEL HY5000
MIGUN MEDICAL INSTRUMENT CO. LTD. 510(k) NO: K032449(TRADITIONAL)
ATTN: EDWARD A KROLL PHONE NO : 440-546-9810
5905 FAWN LANE SE DECISION MADE: 22-OCT-03
CLEVELAND, OH 44141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DESENS-IONOMER
MILTON HODOSH, M.D. 510(k) NO: K032175(TRADITIONAL)
ATTN: MILTON HODOSH PHONE NO : 401-781-3591
243 ELWOOD AVE. SE DECISION MADE: 09-OCT-03
PROVIDENCE, RI 02907 510(k) STATEMENT
DEVICE: BIO-INTRAFIX TIBIAL SCREW AND SHEATH
MITEK WORLDWIDE 510(k) NO: K032167(TRADITIONAL)
ATTN: KAREN K SYLVIA PHONE NO : 781-251-2704
A JOHNSON & JOHNSON COMPANY SE DECISION MADE: 15-OCT-03
249 VANDERBILT AVENUE 510(k) SUMMARY AVAILABLE FROM FDA
NORWOOD, MA 02062
DEVICE: MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 401
MK-DENT GMBH 510(k) NO: K032234(TRADITIONAL)
ATTN: MARTINA GUNDEROTH PHONE NO : 49 451 3882860
KATHARINENSTR. 5 SE DECISION MADE: 02-OCT-03
LUBECK, GERMANY 23554 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARESTATION 126S VIDEOPHONE
MOTION MEDIA TECHNOLOGY INC. 510(k) NO: K031863(TRADITIONAL)
ATTN: STUART R ROSS PHONE NO : 910-395-6100
6714 NETHERLANDS DRIVE SE DECISION MADE: 10-OCT-03
WILMINGTON, NC 28405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPSY BREAST COIL, MODEL BBC
MRI DEVICES CORP. 510(k) NO: K032576(SPECIAL)
ATTN: TOM SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SE DECISION MADE: 23-OCT-03
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: KFA-12 KNEE, FOOT, AND ANKLE ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K033151(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SE DECISION MADE: 10-OCT-03
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: HAC-12 AND HAC-30 HEAD ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K033152(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SE DECISION MADE: 10-OCT-03
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: DIO-DENT 10 DENTAL DIODE LASER
MSQ (M2) LTD. 510(k) NO: K031819(TRADITIONAL)
ATTN: ARAVA HACOHEN PHONE NO : 972 9 7718130
117 AHUZAH ST. SE DECISION MADE: 30-OCT-03
RA'ANANNA, ISRAEL 43373 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROPHY-MATE
NAKANISHI, INC. 510(k) NO: K032395(TRADITIONAL)
ATTN: HIROJI SEKIGUCHI PHONE NO : 028 964 3380
700 SHIMOHINATA SE DECISION MADE: 17-OCT-03
KANUMA-SHI, TOCHIGI-KEN, JAPAN 322510(k) STATEMENT
DEVICE: MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM
NDO SURGICAL, INC. 510(k) NO: K032820(SPECIAL)
ATTN: ERIC BANNON PHONE NO : 508-337-8881
125 HIGH ST., SE DECISION MADE: 23-OCT-03
SUITE 7 510(k) SUMMARY AVAILABLE FROM FDA
MANSFIELD, MA 02048
DEVICE: SUPEROPEN 0.23T, MODEL NAM-P023A
NEUSOFT DIGITAL MEDICAL SYSTEMS CO510(k) NO: K033315(TRADITIONAL)
ATTN: WANG ZHIQIANG PHONE NO : 86 24 83665003
NO.3-11, WENHUA ROAD SE DECISION MADE: 29-OCT-03
HEPING DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
SHENYANG, LIAONING, CHINA 110004 THIRD PARTY REVIEW
DEVICE: NBD DISPOSABLE RF CANNULAE
NEW BUSINESS DEVELOPMENT, LLC 510(k) NO: K032196(TRADITIONAL)
ATTN: TIMOTHY B LUSBY PHONE NO : 678-852-5504
605 INDUSTRIAL COURT SE DECISION MADE: 09-OCT-03
WOODSTOCK, GA 30189 510(k) STATEMENT
DEVICE: GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000
NIDEK, INC. 510(k) NO: K032085(TRADITIONAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900
21911 ERIE LN. SE DECISION MADE: 03-OCT-03
LAKE FOREST, CA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIPRO DISPOSABLE SYRINGES
NIPRO MEDICAL CORP. 510(k) NO: K030683(TRADITIONAL)
ATTN: KAELYN B HADLEY PHONE NO : 859-224-8256
1384 COPPERFIELD COURT SE DECISION MADE: 31-OCT-03
LEXINGTON, KY 40514-1268 510(k) STATEMENT
DEVICE: MODEL 3100 WRISTOX PULSE OXIMETER
NONIN MEDICAL, INC. 510(k) NO: K030668(TRADITIONAL)
ATTN: RICHARD P BENNETT PHONE NO : 763-577-3166
2605 FERNBROOK LANE, NORTH SE DECISION MADE: 17-OCT-03
MINNEAPOLIS, MN 55447-4755 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CZR PRESS
NORITAKE CO., INC. 510(k) NO: K033049(TRADITIONAL)
ATTN: IVAN J WASSERMAN PHONE NO : 202-342-8400
3050 K STREET, NW, STE 400 SE DECISION MADE: 24-OCT-03
WASHINGTON, DC 20007 510(k) STATEMENT
DEVICE: CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5
NOUVAG AG 510(k) NO: K022505(TRADITIONAL)
ATTN: ERICH FORSTER PHONE NO : 004 156 2019500
REUSSWEHRSTRASSE 1 SE DECISION MADE: 01-OCT-03
GEBENSTORF, SWITZERLAND 5412 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN
NOVAMIN TECHNOLOGY, INC. 510(k) NO: K033295(TRADITIONAL)
ATTN: DAVID C GREENSPAN PHONE NO : 386-418-1551
13709 PROGRESS BLVD, # 23 SE DECISION MADE: 28-OCT-03
ALACHUA, FL 32615 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NORMED COMPRESSION BONE SCREW SYSTEM
NOVIACE CORPORATION 510(k) NO: K032634(TRADITIONAL)
ATTN: ALBERT ENAYATI PHONE NO : 201-444-7306
809 CARTER LANE SE DECISION MADE: 06-OCT-03
PARAMUS, NJ 07652 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVASIVE NEUROVISION JJB SYSTEM
NUVASIVE, INC. 510(k) NO: K032083(TRADITIONAL)
ATTN: LAETITIA BERNARD PHONE NO : 858-271-7070
10065 OLD GROVE RD. SE DECISION MADE: 24-OCT-03
SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVASIVE CEMENT RESTRICTOR
NUVASIVE, INC. 510(k) NO: K032180(TRADITIONAL)
ATTN: LAETITIA BERNARD PHONE NO : 858-527-1918
10065 OLD GROVE RD., SUITE A SE DECISION MADE: 07-OCT-03
SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS
NXSTAGE MEDICAL, INC. 510(k) NO: K032356(TRADITIONAL)
ATTN: NORMA LEMAY PHONE NO : 978-687-4700
439 SOUTH UNION ST. SE DECISION MADE: 28-OCT-03
SUITE 501 510(k) SUMMARY AVAILABLE FROM FDA
LAWRENCE, MA 01843
DEVICE: EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS AC
OLYMPUS OPTICAL CO., LTD. 510(k) NO: K033225(TRADITIONAL)
ATTN: TINA STEFFANIE-OAK PHONE NO : 631-844-5477
TWO CORPORATE CENTER DR. SE DECISION MADE: 16-OCT-03
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOS
OLYMPUS OPTO-ELECTRONICS CO., LTD.510(k) NO: K032177(TRADITIONAL)
ATTN: TINA STEFFANIE-OAK PHONE NO : 631-844-5477
TWO CORPORATE CENTER DR. SE DECISION MADE: 02-OCT-03
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFESTENT SDS BILIARY ENDOPROSTHESIS
ORBUS MEDICAL TECHNOLOGIES 510(k) NO: K033212(SPECIAL)
ATTN: JIM CLOSSICK PHONE NO : 954-730-0711
5363 N.W. 35TH AVE. SE DECISION MADE: 30-OCT-03
FT. LAUDERDALE, FL 33309-6315 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORT CASSETTE
OREX COMPUTED RADIOGRAPHY LTD 510(k) NO: K032654(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 09-OCT-03
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL
ORION DIAGNOSTICA, DIV. ORION CORP510(k) NO: K031607(TRADITIONAL)
ATTN: ANNIKKA RANTAMA PHONE NO : 358 104 292736
KOIVU-MANKKAAN TIE 6 SE DECISION MADE: 10-OCT-03
ESPOO, FINLAND 02200 510(k) STATEMENT
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS
ORTHO-CLINICAL DIAGNOSTICS 510(k) NO: K033127(TRADITIONAL)
ATTN: SARAH PARSONS PHONE NO : 585-453-3154
100 INDIGO CREEK DR. SE DECISION MADE: 31-OCT-03
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K032993(TRADITIONAL)
ATTN: SARAH PARSONS PHONE NO : 585-453-3154
100 INDIGO CREEK DR. SE DECISION MADE: 31-OCT-03
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STS SCREW
ORTHO-PRO LLC 510(k) NO: K032682(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD SE DECISION MADE: 22-OCT-03
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SC TOTAL HIP SYSTEM
ORTHOPEDIC ALLIANCE LLC 510(k) NO: K031474(TRADITIONAL)
ATTN: ROGER WILLIAMS PHONE NO : 909-304-9001
41558 EASTMAN DRIVE SE DECISION MADE: 15-OCT-03
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
MARIETTA, CA 92562
DEVICE: NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE
ORTHOSOFT, INC. 510(k) NO: K032917(SPECIAL)
ATTN: CHRISTOPHER MCLEAN PHONE NO : 514 861 4074
75 QUEEN ST., SUITE 3300 SE DECISION MADE: 21-OCT-03
MONTREAL, QUEBEC, CANADA H3C 2N6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MORALES PROTRACTION FACEMASK
ORTOSIM, S.A. DE C.V. 510(k) NO: K032392(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LANE SE DECISION MADE: 22-OCT-03
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: IMMIX PLASTIFILM
OSTEOBIOLOGICS, INC. 510(k) NO: K032673(SPECIAL)
ATTN: GABRIELE G NIEDERAUER PHONE NO : 210-690-2131
UNIVERSITY BUSINESS PARK SE DECISION MADE: 02-OCT-03
12500 NETWORK, SUITE 112 510(k) SUMMARY AVAILABLE FROM FDA
SAN ANTONIO, TX 78249-3308
DEVICE: PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR
OSYPKA MEDICAL, INC. 510(k) NO: K033130(SPECIAL)
ATTN: MARKUS J OSYPKA PHONE NO : 858-454-0021
7855 IVANHOE AVE. SE DECISION MADE: 31-OCT-03
SUITE 226 510(k) SUMMARY AVAILABLE FROM FDA
LA JOLLA, CA 92037
DEVICE: MECHANICAL WHEEHCHAIR
PACIFIC MEDICAL SUPPLIERS, INC. 510(k) NO: K033141(TRADITIONAL)
ATTN: STEPHEN T MLCOCH PHONE NO : 631-744-0059
30 NORTHPORT ROAD SE DECISION MADE: 30-OCT-03
SOUND BEACH, NY 11789-1734 510(k) STATEMENT
DEVICE: PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS
PARAGON MEDICAL, INC. 510(k) NO: K032119(TRADITIONAL)
ATTN: DAVID C FURR PHONE NO : 260-459-9475
7822 LADUE GLEN SE DECISION MADE: 29-OCT-03
FORT WAYNE, IN 46804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIAR
PERCLOSE, INC. 510(k) NO: K032929(SPECIAL)
ATTN: JOANNA KUSKOWSKI PHONE NO : 650-474-3331
400 SAGINAW SE DECISION MADE: 22-OCT-03
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE
PERUSAHAAN GETAH ASAS SDN BHD 510(k) NO: K032374(TRADITIONAL)
ATTN: JAMES F LOGAN PHONE NO : 410-837-1751
1301 DEFENSE HIGHWAY SE DECISION MADE: 22-OCT-03
GAMBRILLS, MD 21054-1928 510(k) STATEMENT
DEVICE: RUBBERCARE POWDERED LATEX EXAMINATION GLOVES
PERUSAHAAN PELINDUNG GETAH (M) SDN510(k) NO: K032201(TRADITIONAL)
ATTN: PETER YEW NIENG CHOON PHONE NO : 606 677 2781
EMPAT, SENAWANG INDUSTRIAL SE DECISION MADE: 10-OCT-03
ESTATE, 70450 SEREMBAN, NEGERI 510(k) SUMMARY AVAILABLE FROM FDA
SEMBILAN DARUL KHUSUS MALAYSIA, MALI
DEVICE: "PHILIPS PLUS" COMPUTED TOMOGRAPHY SYSTEM
PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K033326(TRADITIONAL)
ATTN: ROBERT L TUROCY PHONE NO : 440-483-3528
595 MINER RD. SE DECISION MADE: 29-OCT-03
HIGHLAND HGTS., OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT M
PHILIPS MEDIZINSYSTEME BOBLINGEN G510(k) NO: K032858(SPECIAL)
ATTN: HAUKE SCHIK PHONE NO : 497 031 4632031
HEWLETT-PACKARD-STR. 2 SE DECISION MADE: 10-OCT-03
BOEBLINGEN, GERMANY D 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACURA ELITE GRAVITY COMPENSATING RESERVOIR
PHOENIX BIOMEDICAL CORP. 510(k) NO: K030468(TRADITIONAL)
ATTN: COURTNEY SMITH PHONE NO : 610-539-9300
2495 GENERAL ARMISTEAD AVE. SE DECISION MADE: 15-OCT-03
P.O. BOX 80390 510(k) STATEMENT
VALLEY FORGE, PA 19484
DEVICE: NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03
POLYGANICS BV 510(k) NO: K032115(TRADITIONAL)
ATTN: JAN BART HAK PHONE NO : 31 50 5886588
L.J. ZIELSTRAWEG 1 SE DECISION MADE: 10-OCT-03
GRONINGEN, NETHERLANDS 9713-GX 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ SPLINT & EZ SPLINT PM
POWER PRODUCTS, INC.-SPLINTEK 510(k) NO: K022809(TRADITIONAL)
ATTN: CAROLANN KOTULA PHONE NO : 516-482-9001
55 NORTHERN BLVD. SE DECISION MADE: 17-OCT-03
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: PROWESS
PROWESS, INC. 510(k) NO: K032456(TRADITIONAL)
ATTN: W. JAMES BISHOP PHONE NO : 530-898-0660
1370 RIDGEWOOD DR., #20 SE DECISION MADE: 16-OCT-03
CHICO, CA 95973-7803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LTV-1000 VENTILATOR
PULMONETIC SYSTEMS, INC. 510(k) NO: K032226(TRADITIONAL)
ATTN: ROBERT C SAMEC PHONE NO : 763-398-8305
17400 MEDINA RD. SE DECISION MADE: 16-OCT-03
SUITE 100 510(k) STATEMENT
MINNEAPOLIS, MN 55447
DEVICE: GLYCOHEMOSURE HBA1C CONTROL
QUANTIMETRIX CORP. 510(k) NO: K032791(TRADITIONAL)
ATTN: GEBHARD NEYER PHONE NO : 310-536-0006
2005 MANHATTAN BEACH BLVD. SE DECISION MADE: 30-OCT-03
REDONDO BEACH, CA 90278-1205 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPR SYSTEM
RADIANCY (ISRAEL) LTD. 510(k) NO: K033181(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 24-OCT-03
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIUS COUGAR WIRE
RADIUS MEDICAL TECHNOLOGIES, INC. 510(k) NO: K032899(SPECIAL)
ATTN: DEBBIE IAMPIETRO PHONE NO : 508-435-9893
7 TIFFANY TRAIL SE DECISION MADE: 17-OCT-03
HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH
REMCO ITALIA S.P.A. 510(k) NO: K032200(ABBREVIATED)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 03-OCT-03
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NASAL JACKS MASK
RESMED LTD. 510(k) NO: K032433(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2400
14040 DANIELSON ST. SE DECISION MADE: 24-OCT-03
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOSET SPIRIT SYSTEM
RESMED LTD. 510(k) NO: K032480(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238
14040 DANIELSON ST. SE DECISION MADE: 16-OCT-03
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NICO WITH MARS, MODEL 7300
RESPIRONICS NOVAMETRIX, INC. 510(k) NO: K030886(TRADITIONAL)
ATTN: MICHAEL MALIS PHONE NO : 203-697-6442
5 TECHNOLOGY DR. SE DECISION MADE: 07-OCT-03
WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTMONITOR 2 PROFESSIONAL SERIES (PS)
RESPIRONICS, INC. 510(k) NO: K032403(ABBREVIATED)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120
1001 MURRY RIDGE LN. SE DECISION MADE: 27-OCT-03
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AN
RICH-MAR CORP. 510(k) NO: K032941(SPECIAL)
ATTN: DAVID RICHARDS PHONE NO : 800-762-4665
P.O. BOX 879 SE DECISION MADE: 22-OCT-03
INOLA, OK 74036-0879 510(k) STATEMENT
DEVICE: POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.91
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K030082(TRADITIONAL)
ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY. SE DECISION MADE: 30-OCT-03
VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONLINE TDM AMIKA
ROCHE DIAGNOSTICS CORP. 510(k) NO: K032279(TRADITIONAL)
ATTN: KERWIN KAUFMAN PHONE NO : 317-521-7637
9115 HAGUE RD. SE DECISION MADE: 10-OCT-03
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCHE DIAGNOSTICS OMNI S ANALYZER
ROCHE DIAGNOSTICS CORP. 510(k) NO: K032311(TRADITIONAL)
ATTN: JENNIFER TRIBBETT PHONE NO : 317-521-3742
P.O. BOX 50457 SE DECISION MADE: 17-OCT-03
9115 HAGUE RD. 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0457
DEVICE: CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS
ROCHE DIAGNOSTICS CORP. 510(k) NO: K032437(TRADITIONAL)
ATTN: JENNIFER TRIBBETT PHONE NO : 317-521-3742
9115 HAGUE RD. SE DECISION MADE: 08-OCT-03
PO BX 50457 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0457
DEVICE: ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2
ROCHE DIAGNOSTICS CORP. 510(k) NO: K033009(SPECIAL)
ATTN: SHERRI L COENEN PHONE NO : 317-521-3831
9115 HAGUE RD. SE DECISION MADE: 16-OCT-03
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHE
ROCHE DIAGNOSTICS CORP. 510(k) NO: K033165(ABBREVIATED)
ATTN: KERWIN KAUFMAN PHONE NO : 317-521-7637
9115 HAGUE RD. SE DECISION MADE: 14-OCT-03
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBAS INTEGRA ALP IFCC GEN.2
ROCHE DIAGNOSTICS CORP. 510(k) NO: K033185(SPECIAL)
ATTN: SHERRI L COENEN PHONE NO : 317-521-3831
9115 HAGUE RD. SE DECISION MADE: 14-OCT-03
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM
SANARUS MEDICAL, INC. 510(k) NO: K032506(TRADITIONAL)
ATTN: TRENA DEPEL PHONE NO : 925-460-6080
5880 WEST LAS POSITAS BLVD. SE DECISION MADE: 09-OCT-03
SUITE 52 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANTON, CA 94588
DEVICE: MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI
SATELEC 510(k) NO: K032465(TRADITIONAL)
ATTN: JACQUELINE E MASSE PHONE NO : 781-239-8108
70 WALNUT ST. SE DECISION MADE: 21-OCT-03
WELLESLEY, MA 02481 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOMA ANTERIOR CERVICAL PLATE SYSTEM
SEASPINE 510(k) NO: K032368(TRADITIONAL)
ATTN: DIANA SMITH PHONE NO : 619-251-9132
727 PARK BLVD. SE DECISION MADE: 09-OCT-03
SAN DIEGO, CA 92101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1
SECTRA AB 510(k) NO: K033088(SPECIAL)
ATTN: CARL ALLETTO PHONE NO : 214-262-4209
1100 LAKEVIEW BLVD. SE DECISION MADE: 29-OCT-03
DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SECTRA ORTHOPEDIC PACKAGE
SECTRA-IMTEC AB 510(k) NO: K031590(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 214-262-4209
1100 LAKEVIEW BLVD. SE DECISION MADE: 02-OCT-03
DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE VINYL EXAMINATION GLOVE
SHANGHAI FOREMOST PLASTIC INDUSTRI510(k) NO: K032071(ABBREVIATED)
ATTN: WILLIAM E HARRIS PHONE NO : 727-787-7250
30798 US HWY. 19N SE DECISION MADE: 10-OCT-03
PALM HARBOR, FL 34684 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SHANGHAI GIANTMAX POWDERED CLEAR VINYL EXAMINATION GLOVES
SHANGHAI GIANTMAX PLASTIC PRODUCT 510(k) NO: K032745(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD. SE DECISION MADE: 17-OCT-03
SUITE 200 510(k) STATEMENT
GREAT NECK, NY 11021
DEVICE: SHANGHAI GIANTMAX CLEAR VINYL POWDER FREE EXAMINATION GLOVES
SHANGHAI GIANTMAX PLASTIC PRODUCT 510(k) NO: K032746(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD. SE DECISION MADE: 17-OCT-03
SUITE 200 510(k) STATEMENT
GREAT NECK, NY 11021
DEVICE: PRE-POWDERED, NON-STERILE, VINYL EXAM GLOVES, YELLOW
SHANGHAI JIAWANG INDUSTRIAL CO. LT510(k) NO: K032792(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D EMERALD SE DECISION MADE: 15-OCT-03
SPARKS,, NV 89434-9550 510(k) STATEMENT
DEVICE: POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLOR (TESTED FOR
SHEN WEI (USA), INC. 510(k) NO: K032024(TRADITIONAL)
ATTN: BELLE M CHOU PHONE NO : 510-429-8692
2845 WHIPPLE RD. SE DECISION MADE: 29-OCT-03
UNION CITY, CA 94587 510(k) STATEMENT
DEVICE: POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, BLUE COLOR
SHEN WEI (USA), INC. 510(k) NO: K032084(TRADITIONAL)
ATTN: BELLE CHOU PHONE NO : 510-429-8692
2845 WHIPPLE RD. SE DECISION MADE: 29-OCT-03
UNION CITY, CA 94587 510(k) STATEMENT
DEVICE: RHYTHM TOUCH Q 2-WAY
SHOCKIM ENTERPRISES, LTD. 510(k) NO: K032178(TRADITIONAL)
ATTN: GREG HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 15-OCT-03
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM AVANTO MR SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K032428(TRADITIONAL)
ATTN: NEALIE HARTMAN PHONE NO : 610-448-1769
51 VALLEY STREAM PKWY. SE DECISION MADE: 16-OCT-03
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROMLC
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K032790(SPECIAL)
ATTN: KEN NEHMER PHONE NO : 925-602-8011
4040 NELSON AVE. SE DECISION MADE: 02-OCT-03
CONCORD, CA 94520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOLINE ANTARES WITH CLARIFY VE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K033196(TRADITIONAL)
ATTN: JUDI HOFFMAN PHONE NO : 425-557-1229
22010 S.E. 51ST ST. SE DECISION MADE: 16-OCT-03
ISSAQUAH, WA 98029-7298 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CONKLUSION PEDICLE SCREW SYSTEM
SIGNUS MEDICAL LLC. 510(k) NO: K031455(TRADITIONAL)
ATTN: THOMAS HOGHAUG PHONE NO : 952-974-9456
6713 LAKEWAY DR. SE DECISION MADE: 22-OCT-03
CHANHASSEN, MN 55317 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOPHOS XG DS/CEPH
SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K033073(SPECIAL)
ATTN: SHEILA M HEMEON PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 10-OCT-03
NORTH ATTLEBORO, MA 02760-4153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIVEX SYSTEM
SMITH & NEPHEW, INC. 510(k) NO: K032387(TRADITIONAL)
ATTN: KAREN PROVENCHER PHONE NO : 978-749-1365
150 MINUTEMAN RD. SE DECISION MADE: 29-OCT-03
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENESIS II POROUS PLUS HA KNEE SYSTEM
SMITH & NEPHEW, INC. 510(k) NO: K032683(ABBREVIATED)
ATTN: JANET JOHNSON-AKIL PHONE NO : 901-399-5153
1450 E. BROOKS RD. SE DECISION MADE: 15-OCT-03
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIGEN STRAIGHT HUMERAL NAIL SYSTEM
SMITH & NEPHEW, INC. 510(k) NO: K032722(SPECIAL)
ATTN: JANET JOHNSON AKIL PHONE NO : 901-399-5153
1450 E. BROOKS RD. SE DECISION MADE: 01-OCT-03
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARIEFIX
SOFRADIM PRODUCTION 510(k) NO: K032093(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 22-OCT-03
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHIRAZ-JAVA SPINAL FIXATION SYSTEM
SPINE NEXT SA 510(k) NO: K031265(TRADITIONAL)
ATTN: DIANE JOHNSON PHONE NO : 410-409-8276
104 GREENWOOD CREEK RD. SE DECISION MADE: 09-OCT-03
QUEENSTOWN, MD 21658 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINERX-LDM
SPINERX TECHNOLOGY 510(k) NO: K031862(TRADITIONAL)
ATTN: HUGHIE WATSON PHONE NO : 713-983-0939
6100 BRITTMOORE RD SE DECISION MADE: 31-OCT-03
BLDG S 510(k) SUMMARY AVAILABLE FROM FDA
HOUSTON, TX 77041
DEVICE: PLUS PIVOT LINK UNIVERSAL SYSTEM
SPINEVISION, INC. 510(k) NO: K032398(TRADITIONAL)
ATTN: LYNETTE WHITAKER PHONE NO : 574-269-9776
3003 SUMMIT BLVD. STE 1500 SE DECISION MADE: 31-OCT-03
ATLANTA, GA 30319 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
STANBIO LABORATORY 510(k) NO: K032482(TRADITIONAL)
ATTN: KIRK JOHNSON PHONE NO : 830-249-0772
1261 NORTH MAIN ST. SE DECISION MADE: 24-OCT-03
BOERNE, TX 78006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERT
STELKAST COMPANY 510(k) NO: K031901(SPECIAL)
ATTN: DONALD A STEVENS PHONE NO : 724-941-6368
200 HIDDEN VALLEY RD. SE DECISION MADE: 10-OCT-03
MCMURRAY, PA 15317 510(k) STATEMENT
DEVICE: MODIFICATION TO: STELLARTECH COAGULATION SYSTEM (MODELS 1100C-11
STELLARTECH RESEARCH CORP. 510(k) NO: K032721(SPECIAL)
ATTN: GARY A SEEGER PHONE NO : 408-331-3138
1346 BORDEAUX DR. SE DECISION MADE: 06-OCT-03
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERISIL ANTIMICROBIAL TUBING AND BOTTLE
STERISIL 510(k) NO: K031681(TRADITIONAL)
ATTN: BRAD DOWNS PHONE NO : 719-481-0937
200 S. WILCOX SE DECISION MADE: 30-OCT-03
CASTLE ROCK, CO 80104 510(k) STATEMENT
DEVICE: STICK FLOW
STICK TECH LTD. 510(k) NO: K031341(TRADITIONAL)
ATTN: WILLIAM TROETEL PHONE NO : 914-664-1640
80 PARKWAY WEST SE DECISION MADE: 29-OCT-03
MOUNT VERNON, NY 10552 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ITI SYNOCTA MESO ABUTMENTS
STRAUMANN USA 510(k) NO: K033243(SPECIAL)
ATTN: LINDA JALBERT PHONE NO : 781-890-0001
RESERVOIR PLACE, SE DECISION MADE: 20-OCT-03
1601 TRAPELO ROAD 510(k) SUMMARY AVAILABLE FROM FDA
WALTHAM, MA 02154
DEVICE: STRYKER FLEXIBLE URETEROSCOPE
STRYKER ENDOSCOPY 510(k) NO: K031278(TRADITIONAL)
ATTN: CHRISTOPHER L COOK PHONE NO : 408-754-2288
5900 OPTICAL CT. SE DECISION MADE: 16-OCT-03
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONESOURCE HAC FAST SETTING CEMENT
STRYKER INSTRUMENTS 510(k) NO: K032366(TRADITIONAL)
ATTN: WADE T RUTKOSKIE PHONE NO : 269-323-4226
4100 EAST MILHAM AVE. SE DECISION MADE: 30-OCT-03
KALAMAZOO, MI 49087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUN-RAIN ULTRASONIC THERAPY, SU-100
SUN-RAIN SYSTEM CORP. 510(k) NO: K024013(TRADITIONAL)
ATTN: R. JEN KE-MIN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 31-OCT-03
HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: OPTIBAND LC
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K032407(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 W. COLLINS AVE. SE DECISION MADE: 06-OCT-03
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DAMON FT
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K032408(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 W. COLLINS AVE. SE DECISION MADE: 15-OCT-03
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES 4.0MM TITANIUM (TI.) LOCKING SCREWS
SYNTHES (USA) 510(k) NO: K032559(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 22-OCT-03
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES
SYNTHES (USA) 510(k) NO: K033065(TRADITIONAL)
ATTN: BONNIE SMITH PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 29-OCT-03
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES
SYNTHES (USA) 510(k) NO: K033121(SPECIAL)
ATTN: LISA M BOYLE PHONE NO : 610-647-9700
P.O. BOX 1766 SE DECISION MADE: 20-OCT-03
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222
DEVICE: SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES
SYNTHES (USA) 510(k) NO: K033160(SPECIAL)
ATTN: LISA M BOYLE PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 09-OCT-03
POST OFFICE BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: POWDER FREE LATEX EXAM GLOVES
TAN SIN LIAN INDUSTRIES SDN. BHD. 510(k) NO: K031335(TRADITIONAL)
ATTN: LEE TAN PHONE NO : 215-922-6053
1133, NORTH 4TH ST. SE DECISION MADE: 16-OCT-03
PHILADEPHIA, PA 19123 510(k) STATEMENT
DEVICE: ORTRAUTEK ORTHOGNATHIC SYSTEM
TEKKA 510(k) NO: K031989(TRADITIONAL)
ATTN: FAYYAZ MEMON PHONE NO : 301-263-0544
6512 BANNOCKBURN DRIVE SE DECISION MADE: 28-OCT-03
BETHESDA, MD 20817 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL TEMPERATURE MONITOR, MODEL GT-202, GT-203, GT-204, AND G
TENGHI CO. LTD 510(k) NO: K033069(TRADITIONAL)
ATTN: LIN HEIAO-FENG PHONE NO : 886 4 22754992
112 YI-CHUNG EAST ROAD, SE DECISION MADE: 24-OCT-03
TAIPING CITY 510(k) SUMMARY AVAILABLE FROM FDA
TAICHUNG, CHINA (TAIWAN)
DEVICE: NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/
THE FIRST YEARS, INC. 510(k) NO: K033131(SPECIAL)
ATTN: ROBIN C CONNER PHONE NO : 508-588-1220
ONE KIDDIE DR. SE DECISION MADE: 30-OCT-03
AVON, MA 02322 510(k) STATEMENT
DEVICE: SONOSURG SYSTEM
THE OLYMPUS OPTICAL CO. 510(k) NO: K032066(TRADITIONAL)
ATTN: TINA STEFFANIE-OAK PHONE NO : 516-844-5477
ENDOSCOPE DIVISION SE DECISION MADE: 03-OCT-03
TWO CORPORATE CENTER DRIVE 510(k) SUMMARY AVAILABLE FROM FDA
MELVILLE, NY 11747-3157
DEVICE: MOSFET AUTOSENSE WIRELESS
THOMSON & NIELSEN ELECTRONICS, LTD510(k) NO: K032725(SPECIAL)
ATTN: MARY HERBERT PHONE NO : 613 596 4563
25-B NORTHSIDE RD. SE DECISION MADE: 03-OCT-03
OTTAWA, ONTARIO, CANADA K2H 8S1 510(k) STATEMENT
DEVICE: TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM
TITRONICS RESEARCH & DEVELOPMENT C510(k) NO: K032471(TRADITIONAL)
ATTN: JOSEPH R TITONE PHONE NO : 319-683-2702
2046 REDWING HOLLOW S.W. SE DECISION MADE: 10-OCT-03
OXFORD, IA 52322 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HLS NOETOS SYSTEM
TORNIER S.A. 510(k) NO: K032079(TRADITIONAL)
ATTN: MIREILLE LEMERY PHONE NO : 003 347 6613898
ZIRST-161, RUE LAVOISIER SE DECISION MADE: 02-OCT-03
MONTBONNOT, FRANCE 38330 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-TECH 2 POWER TILT SEATING SYSTEM, MODEL K2PT
TRACK CORPORATION 510(k) NO: K033263(TRADITIONAL)
ATTN: JON EMERY PHONE NO : 616-844-2471
17024 TAFT ROAD SE DECISION MADE: 31-OCT-03
SPRING LAKE, MI 49456 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS
TURBO WHEELCHAIR CO., INC. 510(k) NO: K032731(ABBREVIATED)
ATTN: JANE HERMES PHONE NO : 843-322-0486
76 MERIDIAN RD. SE DECISION MADE: 30-OCT-03
BEAUFORT, SC 29907 510(k) STATEMENT
DEVICE: TARAS THREADED FIXATION PIN
UNION SURGICAL LLC 510(k) NO: K032532(TRADITIONAL)
ATTN: AL WEISENBORN PHONE NO : 305-829-3437
834 CHESTNUT STREET SE DECISION MADE: 22-OCT-03
SUITE G114 510(k) SUMMARY AVAILABLE FROM FDA
PHILADELPHIA, PA 19107
DEVICE: EPT CERTAINTY PREGNANCY TEST
UNIPATH LTD. 510(k) NO: K032939(SPECIAL)
ATTN: LOUISE ROBERTS PHONE NO : 44 123 4835564
PRIORY BUSINESS PARK SE DECISION MADE: 20-OCT-03
BEDFORD, UNITED KINGDOM MK44 3UP 510(k) STATEMENT
DEVICE: UUHC REPROCESSED COMPRESSION SLEEVE DEVICES
UNIVERSITY OF UTAH HOSPITALS AND C510(k) NO: K031189(TRADITIONAL)
ATTN: JACK SPEER PHONE NO : 801-582-6470
1800 EAST 900 SOUTH SE DECISION MADE: 16-OCT-03
SALT LAKE, UT 84108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNOMEDICAL MONICA INFUSION SET
UNOMEDICAL A/S 510(k) NO: K032854(SPECIAL)
ATTN: JOHN M LINDSKOG PHONE NO : 45 46 427810
AAHOLMVEJ 1-3, OSTED SE DECISION MADE: 09-OCT-03
ROSKILDE, DENMARK DK-4000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VACURECT VACUUM CONSTRICTION DEVICE
VACURECT MANUFACTURING (PTY) LTD. 510(k) NO: K032776(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 03-OCT-03
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROMED LATEX SURGICAL GLOVES, POWDERED, STERILE
VAN OOSTVEEN MEDICAL B.V. 510(k) NO: K023139(TRADITIONAL)
ATTN: M.J. VAN OOSTVEEN PHONE NO : 00 31 297282101
HERENWEG 269 SE DECISION MADE: 22-OCT-03
WILNIS, HOLLAND, NETHERLANDS 3648 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PR
VASCULAR SOLUTIONS, INC. 510(k) NO: K032805(SPECIAL)
ATTN: DEBORAH JENSEN PHONE NO : 763-656-4349
6464 SYCAMORE COURT SE DECISION MADE: 01-OCT-03
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIGORMIST COMPRESSOR NEBULIZER
VEGA TECHNOLOGIES, INC. 510(k) NO: K031413(TRADITIONAL)
ATTN: JOSEPH LU PHONE NO : 886 2 25416996
11F-13, 100 CHANG-CHUN RD. SE DECISION MADE: 07-OCT-03
TAIPEI, CHINA (TAIWAN) 104 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VELOPEX AQUACUT FLUID ABRASION UNIT
VELOPEX INTERNATIONAL, INC. 510(k) NO: K024105(TRADITIONAL)
ATTN: TONY URELLA PHONE NO : 407-957-3900
105 EAST 17TH ST. SE DECISION MADE: 09-OCT-03
ST. CLOUD, FL 34769 510(k) STATEMENT
DEVICE: VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE
VITAL IMAGES, INC. 510(k) NO: K032748(ABBREVIATED)
ATTN: STEPHEN S ANDERSON PHONE NO : 763-852-4100
3300 FERNBROOK LN. NORTH SE DECISION MADE: 29-OCT-03
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
PLYMOUTH, MN 55447
DEVICE: BREAS PV 10I CPAP SYSTEM, MODEL PV 10I
VITAL SIGNS, INC. 510(k) NO: K030985(TRADITIONAL)
ATTN: ANTHONY P MARTINO PHONE NO : 973-790-1330
20 CAMPUS RD. SE DECISION MADE: 15-OCT-03
TOTOWA, NJ 07512 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERFADEX SOLUTION FOR LUNG PRESERVATION
VITROLIFE AB 510(k) NO: K022730(TRADITIONAL)
ATTN: KARL A POSSELT PHONE NO : 908-284-2246
155 CIDER MILL RD. SE DECISION MADE: 27-OCT-03
RINGOES, NJ 08551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIVATIP MICROWAVE ABLATION PROBE
VIVANT MEDICAL, INC. 510(k) NO: K032702(SPECIAL)
ATTN: STEVEN KIM PHONE NO : 650-694-2900
1916-A OLD MIDDLEFIELD WAY SE DECISION MADE: 03-OCT-03
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER
VIVOSONIC, INC. 510(k) NO: K033108(SPECIAL)
ATTN: YURI SOKOLOV PHONE NO : 877 255 7685
56 ABERFOYLE CRESCENT SE DECISION MADE: 27-OCT-03
SUITE 620 510(k) SUMMARY AVAILABLE FROM FDA
TORONTO, ON, CANADA M8X 2W4
DEVICE: IONOFIL COLOR AC
VOCO GMBH 510(k) NO: K033068(TRADITIONAL)
ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935
19379 BLUE LAKE LOOP SE DECISION MADE: 31-OCT-03
BEND, OR 97702 510(k) STATEMENT
DEVICE: RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM,
VOLUME INTERACTIONS PTE LTD 510(k) NO: K032924(SPECIAL)
ATTN: JOHN BABY PHONE NO : 65 622 26962
5 SHENTON WAY SE DECISION MADE: 10-OCT-03
#37-04 UIC BUILDING 510(k) STATEMENT
SINGAPORE, SINGAPORE
DEVICE: W.O.M. LASER U100PLUS
W.O.M. WORLD OF MEDICINE AG 510(k) NO: K032023(TRADITIONAL)
ATTN: SUSANNE RAAB PHONE NO : 703-299-0523
320 NORTH COLUMBUS ST. SE DECISION MADE: 01-OCT-03
ALEXANDRIA, VA 22314 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COACH 777-3
WHEELCHAIR & SCOOTER EXPRESS 510(k) NO: K030756(TRADITIONAL)
ATTN: CHRIS TINSLEY PHONE NO : 620-325-2629
4905 A. SAN JACINTO SE DECISION MADE: 06-OCT-03
HOUSTON, TX 77004 510(k) STATEMENT
DEVICE: COACH 777-4
WHEELCHAIR & SCOOTER EXPRESS 510(k) NO: K030757(TRADITIONAL)
ATTN: CHRIS TINSLEY PHONE NO : 620-325-2629
4905 A. SAN JACINTO SE DECISION MADE: 06-OCT-03
HOUSTON, TX 77004 510(k) STATEMENT
DEVICE: F-10 FOLDING POWER CHAIR
WHEELCHAIR & SCOOTER EXPRESS 510(k) NO: K032441(TRADITIONAL)
ATTN: CHRIS TINSLEY PHONE NO : 620-325-2629
4905 A. SAN JACINTO SE DECISION MADE: 06-OCT-03
HOUSTON, TX 77004 510(k) STATEMENT
DEVICE: WIDE 2MP TFT LCD MONITOR SYSTEM IF 1902A
WIDE CORPORATION 510(k) NO: K032960(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1100 LAKEVIEW BLVD. SE DECISION MADE: 08-OCT-03
DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CONSERVE PLUS SPIKED ACETABULAR SHELLS AND CONSERVE TOTAL 56MM F
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K031963(SPECIAL)
ATTN: KATIE LOGEROT PHONE NO : 901-867-4476
5677 AIRLINE RD. SE DECISION MADE: 31-OCT-03
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINICAT DENTOCAT
XORAN TECHNOLOGIES, INC. 510(k) NO: K032243(TRADITIONAL)
ATTN: PREDRAG SUKOVIC PHONE NO : 734-663-7194
309 N. FIRST STREET SE DECISION MADE: 02-OCT-03
ANN ARBOR, MI 48103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XTRAK SUPPORT CATHETER
XTRAK MEDICAL INC. 510(k) NO: K032660(TRADITIONAL)
ATTN: DEBBIE IAMPIETRO PHONE NO : 508-259-7374
7 TIFFANY TRAIL SE DECISION MADE: 29-OCT-03
HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENT
ZIMMER, INC. 510(k) NO: K031061(TRADITIONAL)
ATTN: STEPHEN MCKELVEY PHONE NO : 574-372-4944
P.O. BOX 708 SE DECISION MADE: 09-OCT-03
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER M/L TAPER HIP PROSTHESIS, 7711 SERIES
ZIMMER, INC. 510(k) NO: K032726(TRADITIONAL)
ATTN: LAURA D WILLIAMS PHONE NO : 574-372-4523
P.O. BOX 708 SE DECISION MADE: 22-OCT-03
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZOLL M SERIES NIBP OPTION
ZOLL MEDICAL CORP. 510(k) NO: K032363(TRADITIONAL)
ATTN: SEAN REYNOLDS PHONE NO : 978-421-9655
269 MILL ROAD SE DECISION MADE: 31-OCT-03
CHELMSFORD, MA 01824-4105 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 382
TOTAL WITH SUMMARIES 313
TOTAL WITH STATEMENTS 69
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