510(k)s Final Decisions Rendered for November 2003

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510(k)s Final Decisions Rendered for November 2003

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SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
          510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-NOV-2003 THROUGH 30-NOV-2003

 
DEVICE: PROTEMP 3 GARANT
3M ESPE AG DENTAL PRODUCTS        510(k) NO: K033022(TRADITIONAL)
ATTN: ANDREAS  PETERMANN          PHONE NO : 011 498 1527001395
ESPE PLATZ                        SE DECISION MADE: 21-NOV-03
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP
ACON LABORATORIES, INC.           510(k) NO: K033041(TRADITIONAL)
ATTN: EDWARD  TUNG                PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD.        SE DECISION MADE: 21-NOV-03
SAN DIEGO, CA 92121               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NAVIGATOR I
ADAPTIVE HEALTHCARE TECHNOLOGIES, 510(k) NO: K032879(TRADITIONAL)
ATTN: JOAN  JOHNSON               PHONE NO : 508-420-5035
P.O. BOX 614                      SE DECISION MADE: 13-NOV-03
MARSTONS MILLS, MA 02648          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO RESQPOD CIRCULATORY ENHANCER
ADVANCED CIRCULATORY SYSTEMS, INC.510(k) NO: K033401(SPECIAL)
ATTN: GARY  SYRING                PHONE NO : 608-877-2635
800 LEVANGER LANE                 SE DECISION MADE: 20-NOV-03
STOUGHTON, WI 53589               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATR 5000, LC 5000, IMPLANT SYSTEM
ADVANCED TECHNOLOGY RESEARCH (A.T.510(k) NO: K033597(TRADITIONAL)
ATTN: DANIELE  POLI               PHONE NO : 390 573 364254
VIA GIOVANNI VERGA, 7             SE DECISION MADE: 25-NOV-03
PISTOIA, ITALY 51100              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: THERATEARS CONTACT LENS COMFORT DROPS
ADVANCED VISION RESEARCH, INC.    510(k) NO: K032481(TRADITIONAL)
ATTN: BEVERLEY D VENUTI           PHONE NO : 978-658-6888
269A BALLARDVALE STREET           SE DECISION MADE: 04-NOV-03
WILMINGTON, MA 01887              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AERONEB GO NEBULIZER, MODEL AG-AG2000
AEROGEN, INC.                     510(k) NO: K032849(TRADITIONAL)
ATTN: NANCY E ISAAC               PHONE NO : 650-864-7493
2071 STIERLIN COURT               SE DECISION MADE: 21-NOV-03
MOUNTAIN VIEW, CA 94043           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MDIFICATION TO MEDIPRIME
ALGOTEC SYSTEMS, LTD.             510(k) NO: K033013(SPECIAL)
ATTN: ELI M ORBACH                PHONE NO : 972 2 9932768
P.O. BOX 6718                     SE DECISION MADE: 25-NOV-03
EFRAT, ISRAEL 90435               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM
ALVEOLUS, INC.                    510(k) NO: K032744(TRADITIONAL)
ATTN: HOWARD L SCHRAYER           PHONE NO : 609-924-9510
401 NORTH TRYON ST.               SE DECISION MADE: 13-NOV-03
10TH FLOOR                        510(k) SUMMARY AVAILABLE FROM FDA
CHARLOTTE, NC 28202

 
DEVICE: AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS
ANALOGIC CORP.                    510(k) NO: K033345(SPECIAL)
ATTN: MARVIN  ROSENBAUM           PHONE NO : 978-977-3000
8 CENTENNIAL DR.                  SE DECISION MADE: 19-NOV-03
PEABODY, MA 01960                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPEEDLYSER INFUSION CATHETER KIT
ANGIODYNAMICS, INC.               510(k) NO: K033443(SPECIAL)
ATTN: TERI  JUCKETT               PHONE NO : 518-798-1215
603 QUEENSBURY AVE.               SE DECISION MADE: 19-NOV-03
QUEENSBURY, NY 12804              510(k) STATEMENT

DEVICE: ANZAI AZ-733 RESPIRATORY GATING SYSTEM
ANZAI MEDICAL CO, LTD.            510(k) NO: K031385(TRADITIONAL)
ATTN: T. WHIT  ATHEY              PHONE NO : 301-570-0013
2305 GOLD MINE RD.                SE DECISION MADE: 10-NOV-03
BROOKEVILLE, MD 20833-2233        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-
AOMORI OLYMPUS CO., LTD.          510(k) NO: K033333(SPECIAL)
ATTN: TINA  STEFFANIE-OAK         PHONE NO : 631-844-5477
2 CORPORATE CENTER DR.            SE DECISION MADE: 14-NOV-03
MELVILLE, NY 11747-3157           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATA
ARCADIA MEDICAL CORPORATION       510(k) NO: K031553(TRADITIONAL)
ATTN: ARTHUR  WARD                PHONE NO : 813-645-2855
962 ALLEGRO LANE                  SE DECISION MADE: 18-NOV-03
APOLLO BEACH, FL 33572            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL
ARROW INTL., INC.                 510(k) NO: K031153(TRADITIONAL)
ATTN: WILLIAM G MCLAIN            PHONE NO : 610-378-0131
2400 BERNVILLE RD.                SE DECISION MADE: 25-NOV-03
READING, PA 19605                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS
ARTHREX, INC.                     510(k) NO: K031666(TRADITIONAL)
ATTN: ANN  WATERHOUSE             PHONE NO : 239-643-5553
2885 SOUTH HORSESHOE DR.          SE DECISION MADE: 18-NOV-03
NAPLES, FL 34104                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHROCARE ARTHROWANDS
ARTHROCARE CORP.                  510(k) NO: K033584(SPECIAL)
ATTN: VALERIE  DEFIESTA-NG        PHONE NO : 408-736-0224
680 VAQUEROS AVE.                 SE DECISION MADE: 28-NOV-03
SUNNYVALE, CA 94085               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTELON SURGICAL SUTURE
ARTIMPLANT AB                     510(k) NO: K032160(TRADITIONAL)
ATTN: RUSS  PAGANO                PHONE NO : 202-546-1262
719 A STREET NE                   SE DECISION MADE: 17-NOV-03
WASHINGTON, DC 20002              510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: AXIOM BIOLASER LLLT SERIES-3
AXIOM USA. INC                    510(k) NO: K033015(TRADITIONAL)
ATTN: JIM  GIBSON                 PHONE NO : 813-249-6444
9423 CORPORATE LAKE DRIVE         SE DECISION MADE: 25-NOV-03
TAMPA, FL 33634                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03
BAUSCH & LOMB, INC.               510(k) NO: K031646(TRADITIONAL)
ATTN: PAUL G STAPLETON            PHONE NO : 585-338-8172
1400 NORTH GOODMAN ST.            SE DECISION MADE: 14-NOV-03
ROCHESTER, NY 14609               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q
BAXTER HEALTHCARE CORP.           510(k) NO: K031676(TRADITIONAL)
ATTN: DAVID E CURTIN              PHONE NO : 847-473-6079
1620 WAUKEGAN RD., MPR-A2E        SE DECISION MADE: 20-NOV-03
MCGAW PARK, IL 60085-6730         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM
BAYER DIAGNOSTICS CORP.           510(k) NO: K033007(TRADITIONAL)
ATTN: KENNETH T EDDS              PHONE NO : 914-524-2446
511 BENEDICT AVE.                 SE DECISION MADE: 14-NOV-03
TARRYTOWN, NY 10591-5097          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER
BECTON DICKINSON & CO.            510(k) NO: K033350(SPECIAL)
ATTN: M. WENDY  BALLESTEROS       PHONE NO : 201-847-6280
1 BECTON DRIVE                    SE DECISION MADE: 18-NOV-03
FRANKLIN LAKES, NJ 07417          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BESMED VARIOUS MODELS OF TENS, BE-550/BE-660
BESMED HEALTH BUSINESS CORP.      510(k) NO: K031374(TRADITIONAL)
ATTN: DR. JEN  KE MIN             PHONE NO : 720-962-5412
58 FU-CHIUN ST.                   SE DECISION MADE: 28-NOV-03
HSIN CHU CITY, CHINA (TAIWAN) 300 510(k) STATEMENT

DEVICE: BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-58
BESMED HEALTH BUSINESS CORP.      510(k) NO: K031375(TRADITIONAL)
ATTN: DR. JEN  KE MIN             PHONE NO : 720-962-5412
58 FU-CHIUN ST.                   SE DECISION MADE: 20-NOV-03
HSIN CHU CITY, CHINA (TAIWAN) 300 510(k) STATEMENT

DEVICE: HBA SPERM-HYALURONAN BINDING ASSAY
BIO-COAT, INC.                    510(k) NO: K032874(TRADITIONAL)
ATTN: JAMES B JOHNSTON            PHONE NO : 215-572-8977
455 PENNSYLVANIA AVE.             SE DECISION MADE: 24-NOV-03
SUITE 120                         510(k) STATEMENT
FORT WASHINGTON, PA 19034

DEVICE: INVISIJECT RESUSABLE AUTO-INJECTOR
BIOGEN                            510(k) NO: K032425(TRADITIONAL)
ATTN: MICHAEL  POIRIER            PHONE NO : 617-679-6459
14 CAMBRIDGE CENTER               SE DECISION MADE: 05-NOV-03
CAMBRIDGE, MA 02142               510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: VITEK 2 GRAM NEGATIVE GATIFLOXACIN
BIOMERIEUX, INC.                  510(k) NO: K032788(TRADITIONAL)
ATTN: NANCY  WEAVER               PHONE NO : 314-731-8695
595 ANGLUM DR.                    SE DECISION MADE: 04-NOV-03
HAZELWOOD, MO 63042-2320          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITEK 2 GRAM NEGATIVE MOXIFLOXACIN
BIOMERIEUX, INC.                  510(k) NO: K032861(TRADITIONAL)
ATTN: NANCY  WEAVER               PHONE NO : 314-731-8695
595 ANGLUM RD.                    SE DECISION MADE: 12-NOV-03
HAZELWOOD, MO 63042               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CALCIGEN PSI BONE GRAFT SUBSTITUTE
BIOMET ORTHOPEDICS, INC.          510(k) NO: K032286(TRADITIONAL)
ATTN: TRACY J BICKEL              PHONE NO : 574-267-6639
56 EAST BELL DR.                  SE DECISION MADE: 20-NOV-03
P.O. BOX 587                      510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587

DEVICE: BI-ANGULAR SHOULDER SYSTEM
BIOMET, INC.                      510(k) NO: K032895(TRADITIONAL)
ATTN: PATRICIA S BERES            PHONE NO : 574-267-6639
56 EAST BELL DR.                  SE DECISION MADE: 20-NOV-03
P.O. BOX 587                      510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587

DEVICE: LACTOSORB TIBIAL L-15 SCREW AND WASHER
BIOMET, INC.                      510(k) NO: K033233(SPECIAL)
ATTN: PATRICIA  SANDBORN BERES    PHONE NO : 574-267-6639
56 BELL DR.                       SE DECISION MADE: 05-NOV-03
PO BOX 587                        510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587

DEVICE: UNIMARK HOME PREGNANCY TEST DEVICE
BIOTECH ATLANTIC, INC.            510(k) NO: K032992(TRADITIONAL)
ATTN: FRANCIS L DENG              PHONE NO : 732-389-4789
BAY F, 6 INDUSTRIAL WAY WEST      SE DECISION MADE: 21-NOV-03
EATONTOWN, NJ 07724               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SCOUT PRO
BIOTRONIK, INC.                   510(k) NO: K033320(SPECIAL)
ATTN: JON  BRUMBAUGH              PHONE NO : 888-345-0374
6024 JEAN RD.                     SE DECISION MADE: 19-NOV-03
LAKE OSWEGO, OR 97035             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BISCEM GI
BISCO, INC.                       510(k) NO: K032597(TRADITIONAL)
ATTN: KATHY  JOUNG                PHONE NO : 847-534-6106
1100 WEST IRVING PARK RD.         SE DECISION MADE: 04-NOV-03
SCHAUMBURG, IL 60193              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG
BOSTON BIOMEDICA, INC.            510(k) NO: K032713(TRADITIONAL)
ATTN: PATRICIA E GARRETT          PHONE NO : 508-580-1900
375 WEST ST.                      SE DECISION MADE: 24-NOV-03
WEST BRIDGEWATER, MA 02379        510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER
BOSTON SCIENTIFIC CORP.           510(k) NO: K033441(SPECIAL)
ATTN: HEIDI M ERICKSON            PHONE NO : 763-494-2564
ONE BOSTON SCIENTIFIC PL.         SE DECISION MADE: 21-NOV-03
NATICK, MA 01760-1537             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDERED, STERILE), CON
BRIGHTWAY HOLDINGS SDN. BHD.      510(k) NO: K032938(TRADITIONAL)
ATTN: G.  BASKARAN                PHONE NO : 603 334 31007
LOT 1559, JALAN ISTIMEWA,         SE DECISION MADE: 20-NOV-03
BATU BELAH                        510(k) STATEMENT
KLANG, SELANGOR, MALAYSIA 42100

DEVICE: BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDER FREE, STERILE) C
BRIGHTWAY HOLDINGS SDN. BHD.      510(k) NO: K032940(TRADITIONAL)
ATTN: G.  BASKARAN                PHONE NO : 603 334 31007
LOT 1559, JALAN ISTIMEWA,         SE DECISION MADE: 20-NOV-03
BATU BELAH                        510(k) STATEMENT
KLANG, SELANGOR, MALAYSIA 42100

DEVICE: BRUNO ELECTRA-RIDE ELITE, MODEL SRE-2000
BRUNO INDEPENDENT LIVING AIDS, INC510(k) NO: K033438(SPECIAL)
ATTN: RICHARD  KELLER             PHONE NO : 262-953-5336
1780 EXECUTIVE DR.                SE DECISION MADE: 20-NOV-03
P.O. BOX 84                       510(k) STATEMENT
OCONOMOWOC, WI 53066

DEVICE: BARD ENDOTRACHEAL TUBE, CUFFED
C.R. BARD, INC.                   510(k) NO: K030792(TRADITIONAL)
ATTN: FRANCES E HARRISON          PHONE NO : 770-784-6257
8195 INDUSTRIAL BLVD.             SE DECISION MADE: 14-NOV-03
COVINGTON, GA 30014               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BARD DUAL LUMEN URETERAL CATHETER
C.R. BARD, INC.                   510(k) NO: K032521(TRADITIONAL)
ATTN: FRANCES  HARRISON           PHONE NO : 770-784-6160
8195 INDUSTRIAL BLVD.             SE DECISION MADE: 14-NOV-03
COVINGTON, GA 30014               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
C.R. BARD, INC.                   510(k) NO: K033245(SPECIAL)
ATTN: MICHAEL A PATZ              PHONE NO : 978-262-4868
129 CONCORD RD., BLDG. #3         SE DECISION MADE: 06-NOV-03
BILLERICA, MA 01821               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT;16FR X 19
C.R. BARD, INC.                   510(k) NO: K033294(SPECIAL)
ATTN: GLENN  NORTON               PHONE NO : 801-595-0700
5425 WEST AMELIA EARHART DR.      SE DECISION MADE: 26-NOV-03
SALT LAKE CITY, UT 84116          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPUS-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH N
CANOPUS MEDICAL SUPPLY CO., LTD.  510(k) NO: K023452(TRADITIONAL)
ATTN: RUBY  LIN                   PHONE NO : 011 886 227162107
201 FU-HSING NORTH RD., 10TH      SE DECISION MADE: 20-NOV-03
FL.                               510(k) STATEMENT
TAIPEI, CHINA (TAIWAN) 105

 
DEVICE: NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND U
CARDINAL HEALTH                   510(k) NO: K032444(TRADITIONAL)
ATTN: ERICA  SETHI                PHONE NO : 847-785-3337
1500 WAUKEGAN RD. BLDG. WM        SE DECISION MADE: 13-NOV-03
MCGAW PARK, IL 60085              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COPC BAND
CENTER FOR ORTHOTIC AND PROSTHETIC510(k) NO: K021594(TRADITIONAL)
ATTN: JOSEPH  TERPENNING          PHONE NO : 703-220-4274
2525 NORTH TENTH ST. #804         SE DECISION MADE: 13-NOV-03
ARLINGTON, VA 22201               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYSTEM 100 ULTRAFILTRATION CATHETER
CHF SOLUTIONS, INC.               510(k) NO: K023874(TRADITIONAL)
ATTN: AMY  PETERSON               PHONE NO : 763-463-4620
SUITE 170-7601 NORTHLAND DR.      SE DECISION MADE: 20-NOV-03
BROOKLYN PARK, MN 55428           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS
CLEAR MEDICAL, INC.               510(k) NO: K033593(TRADITIONAL)
ATTN: MIKE  KOVACS                PHONE NO : 425-401-1414
1776 136TH PL.  NE                SE DECISION MADE: 20-NOV-03
BELLEVUE, WA 98005                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REPROCESSED SINGLE USE DEVICES EP CATHETERS
CLEAR MEDICAL, INC.               510(k) NO: K033595(TRADITIONAL)
ATTN: MIKE  KOVACS                PHONE NO : 425-401-1414
1776 136TH PL.  NE                SE DECISION MADE: 26-NOV-03
BELLEVUE, WA 98005                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATAC HEMOGLOBIN A1C REAGENT KIT
CLINICAL DATA, INC.               510(k) NO: K031042(TRADITIONAL)
ATTN: WYNN  STOCKING              PHONE NO : 714-672-3553
1075 WEST LAMBERT ROAD            SE DECISION MADE: 03-NOV-03
BREA, CA 92821-2944               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GUTTAFLOW
COLTENE/WHALEDENT GMBH & CO. KG   510(k) NO: K032662(TRADITIONAL)
ATTN: HENRY J VOGELSTEIN          PHONE NO : 330-916-8800
235 ASCOT PARKWAY                 SE DECISION MADE: 03-NOV-03
CUYAHOGA FALLS, OH 44223          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KWIKEZE MALE CONDOM APPLICATOR
CONDAX LLC.                       510(k) NO: K031007(ABBREVIATED)
ATTN: ELI J CARTER                PHONE NO : 919-544-4098
1219 LITTLE CREEK RD.             SE DECISION MADE: 14-NOV-03
DURHAM, NC 27713                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ECHOCONNEX COMMUNICATOR
CONNEXMD                          510(k) NO: K033093(TRADITIONAL)
ATTN: CURTIS  LEBLEU              PHONE NO : 206-850-5075
8536 18TH AVENUE NW               SE DECISION MADE: 05-NOV-03
SEATTLE, WA 98117                 510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: COOK CODA BALLOON CATHETER
COOK, INC.                        510(k) NO: K032869(TRADITIONAL)
ATTN: THEODORE  HEISE             PHONE NO : 812-339-2235
750 DANIELS WAY PO BX 489         SE DECISION MADE: 19-NOV-03
BLOOMINGTON, IN 47402             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DOC'S BEST WHITE COPPER CEMENT
COOLEY & COOLEY, LTD.             510(k) NO: K031494(TRADITIONAL)
ATTN: M. JOYCE  HEINRICH          PHONE NO : 713-734-4433
12101-A CULLEN BLVD.              SE DECISION MADE: 12-NOV-03
HOUSTON, TX 77047                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROCLEAR COMPATIBLES MULTIFOCAL
COOPER VISION, INC.               510(k) NO: K032873(TRADITIONAL)
ATTN: LISA  HAHN                  PHONE NO : 757-664-2421
1215 BOISSEVAIN AVE.              SE DECISION MADE: 07-NOV-03
NORFOLK, VA 23507                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ
CTI PET SYSTEMS, INC.             510(k) NO: K033431(SPECIAL)
ATTN: WILLIAM  SKREMSKY           PHONE NO : 865-218-2522
810 INNOVATION DR.                SE DECISION MADE: 20-NOV-03
KNOXVILLE, TN 37932-2571          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTICLEAR MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM
CURELIGHT LTD                     510(k) NO: K032383(TRADITIONAL)
ATTN: JONATHAN S KAHAN            PHONE NO : 202-637-5794
555 THIRTEENTH STREET, N.W.       SE DECISION MADE: 28-NOV-03
WASHINGTON, DC 20004-1109         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CYNOSURE PHOTOGENICA SV LASER
CYNOSURE, INC.                    510(k) NO: K032539(TRADITIONAL)
ATTN: GEORGE  CHO                 PHONE NO : 978-256-4200
10 ELIZABETH DR.                  SE DECISION MADE: 17-NOV-03
CHELMSFORD, MA 01824              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)
DADE BEHRING, INC.                510(k) NO: K032697(TRADITIONAL)
ATTN: LORRAINE H PIESTRAK         PHONE NO : 302-631-6279
GLASGOW BUSINESS COMMUNITY        SE DECISION MADE: 07-NOV-03
P.O. BOX 6101, BUILDING 500       510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714

DEVICE: MICROSCAN RAPID/S PLUS GRAM NEGATIVE MIC/COMBO PANELS
DADE BEHRING, INC.                510(k) NO: K033482(SPECIAL)
ATTN: ROBERT  EUSEBIO             PHONE NO : 916-374-3183
2040 ENTERPRISE BLVD.             SE DECISION MADE: 26-NOV-03
WEST SACRAMENTO, CA 95691         510(k) STATEMENT

DEVICE: DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03
DATEX-OHMEDA                      510(k) NO: K033281(TRADITIONAL)
ATTN: JOEL  KENT                  PHONE NO : 781-449-8685
86 PILGRIM RD.                    SE DECISION MADE: 26-NOV-03
NEEDHAM, MA 02492                 510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES
DEFIBTECH, LLC                    510(k) NO: K033144(TRADITIONAL)
ATTN: JOHN L ROGERS               PHONE NO : 203-453-6654
753 BOSTON POST RD., SUITE 102    SE DECISION MADE: 13-NOV-03
GUILFORD, CT 06437                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DENTATUS OSCIOMAT
DENTATUS USA, LTD.                510(k) NO: K031793(TRADITIONAL)
ATTN: RICHARD C LANZILLOTTO       PHONE NO : 631-744-0059
30 NORTHPORT ROAD                 SE DECISION MADE: 13-NOV-03
SOUND BEACH, NY 11789-1734        510(k) STATEMENT

DEVICE: CONTEC DUO, CONTEC LC, CONTEC LCR
DENTAURUM                         510(k) NO: K030644(TRADITIONAL)
ATTN: JAN W A DOORSCHODT          PHONE NO : 215-968-2858
10 PHEASANT RUN                   SE DECISION MADE: 21-NOV-03
NEWTOWN, PA 18940                 510(k) STATEMENT

DEVICE: DELTA SHOULDER
DEPUY, INC.                       510(k) NO: K021478(TRADITIONAL)
ATTN: JANET G JOHNSON             PHONE NO : 574-371-4907
700 ORTHOPAEDIC DR.               SE DECISION MADE: 18-NOV-03
WARSAW, IN 46581-0988             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS
DEPUY, INC.                       510(k) NO: K033329(TRADITIONAL)
ATTN: RHONDA  MYER                PHONE NO : 574-371-4944
P.O. BOX 988                      SE DECISION MADE: 14-NOV-03
700 ORTHOPAEDIC DRIVE             510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988

DEVICE: DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE
DEROYAL                           510(k) NO: K033057(TRADITIONAL)
ATTN: SHARON  COOK                PHONE NO : 865-362-6157
200 DEBUSK LN.                    SE DECISION MADE: 20-NOV-03
POWELL, TN 37849                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DGH 55 HANDHELD PACHYMETER (PACHMATE)
DGH TECHNOLOGY, INC.              510(k) NO: K033385(TRADITIONAL)
ATTN: M. LUTHER  DETWEILER        PHONE NO : 610-594-9100
110 SUMMIT DR., SUITE B           SE DECISION MADE: 07-NOV-03
EXTON, PA 19341                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE
DIAMOND DIAGNOSTICS, INC.         510(k) NO: K033061(TRADITIONAL)
ATTN: LINDA M STUNDTNER           PHONE NO : 508-429-0450
331 FISKE ST.                     SE DECISION MADE: 07-NOV-03
HOLLISTON, MA 01746               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DRAEGER MICRO2+ AND MASIMO MINISAT
DRAEGER MEDICAL SYSTEMS, INC.     510(k) NO: K032537(SPECIAL)
ATTN: PENELOPE H GRECO            PHONE NO : 978-907-7500
16 ELECTRONICS AVE.               SE DECISION MADE: 25-NOV-03
DANVERS, MA 01923                 510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: CONSULTIVA CASE INPUT STATION, MODEL CIS-1
EASTMAN KODAK COMPANY             510(k) NO: K031132(TRADITIONAL)
ATTN: WIDO  MENHARDT              PHONE NO : 408-858-0718
100 CENTURY CENTER COURT SUITE    SE DECISION MADE: 26-NOV-03
600                               510(k) SUMMARY AVAILABLE FROM FDA
SAN JOSE, CA 95112

DEVICE: EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE,
EDWARDS LIFESCIENCES, LLC.        510(k) NO: K031946(TRADITIONAL)
ATTN: JEAN  CHANG                 PHONE NO : 408-941-9704
1635A SOUTH MAIN STREET           SE DECISION MADE: 03-NOV-03
MILPITAS, CA 94043                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EPI-SCAN, MODEL P 100
EDX EPI-SCAN, INC.                510(k) NO: K032935(SPECIAL)
ATTN: GREG  HOLLAND               PHONE NO : 949-262-0411
3722 AVE. SAUSALITO               SE DECISION MADE: 20-NOV-03
IRVINE, CA 92606                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ESG 4-WHEEL SCOOTER, ESG-03
EMG TECHNOLOGY CO., LTD.          510(k) NO: K033204(TRADITIONAL)
ATTN: JEN  KE-MIN                 PHONE NO : 886 3 5208829
NO. 58, FU-CHINU ST.              SE DECISION MADE: 12-NOV-03
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OXYCON MOBILE
ERICH JAEGER GMBH                 510(k) NO: K023120(TRADITIONAL)
ATTN: EARL  DRAPER                PHONE NO : 714-283-2228
22705 SAVI RANCH PKWY.            SE DECISION MADE: 12-NOV-03
YORBA LINDA, CA 92887-4645        510(k) STATEMENT

DEVICE: ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS
EUROSURGICAL S.A.                 510(k) NO: K030958(TRADITIONAL)
ATTN: KAREN E WARDEN              PHONE NO : 304-598-0525
7000 HAMPTON CENTER               SE DECISION MADE: 20-NOV-03
SUITE G1                          510(k) SUMMARY AVAILABLE FROM FDA
MORGANTOWN, WV 26505

DEVICE: MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM
EV3 INC                           510(k) NO: K033134(SPECIAL)
ATTN: GLEN D SMYTHE               PHONE NO : 763-398-7391
4600 NATHAN LN. NORTH             SE DECISION MADE: 17-NOV-03
PLYMOUTH, MN 55442                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
EV3 INC                           510(k) NO: K033314(SPECIAL)
ATTN: GLEN D SMYTHE               PHONE NO : 763-398-7391
4600 NATHAN LN. NORTH             SE DECISION MADE: 21-NOV-03
PLYMOUTH, MN 55442-2920           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXACTECH 12/14 ALUMINA FEMORAL HEAD; EXACTECH ACUMATCH M-SERIES
EXACTECH, INC.                    510(k) NO: K032964(SPECIAL)
ATTN: GARY J MILLER               PHONE NO : 352-377-1140
2320 N.W. 66TH CT.                SE DECISION MADE: 13-NOV-03
GAINESVILLE, FL 32653             510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: CWAS 1000
FASSTECH                          510(k) NO: K033452(TRADITIONAL)
ATTN: LEE  BRODY                  PHONE NO : 978-663-2800
76 TREBLE COVE RD.                SE DECISION MADE: 28-NOV-03
BUILDING #2                       510(k) SUMMARY AVAILABLE FROM FDA
NORTH BILLERICA, MA 01862         THIRD PARTY REVIEW

DEVICE: FOSSA URETERAL OPEN LUMEN STENT
FOSSA MEDICAL, INC.               510(k) NO: K033368(SPECIAL)
ATTN: GLORIA  KOLB                PHONE NO : 617-275-7481
580 HARRISON AVE., 4TH FL.        SE DECISION MADE: 26-NOV-03
BOSTON, MA 02118                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWERED WHEELCHAIR, MODEL FR168W
FREERIDER, CORP.                  510(k) NO: K033370(TRADITIONAL)
ATTN: ROBERT S MCQUATE            PHONE NO : 602-788-5651
3636 E. COLUMBINE DRIVE           SE DECISION MADE: 28-NOV-03
PHOENIX, AZ 85032                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER
FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K033561(TRADITIONAL)
ATTN: FRANK  GIANELLI             PHONE NO : 203-602-3774
419 WEST AVE.                     SE DECISION MADE: 26-NOV-03
STAMFORD, CT 06902                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K033304(SPECIAL)
ATTN: MELISSA  ROBINSON           PHONE NO : 813-887-2133
8200 WEST TOWER AVE.              SE DECISION MADE: 12-NOV-03
MILWAUKEE, WI 53223               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APEXPRO FH TELEMETRY SYSTEM
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K033365(SPECIAL)
ATTN: DIANA M THORSON             PHONE NO : 714-247-4135
8200 WEST TOWER AVE.              SE DECISION MADE: 06-NOV-03
MILWAUKEE, WI 53223               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K033492(SPECIAL)
ATTN: LISA LEE  MICHELS           PHONE NO : 262-293-1609
8200 WEST TOWER AVE.              SE DECISION MADE: 24-NOV-03
MILWAUKEE, WI 53223               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIGHTSPEED 6.0 CT SCANNER SYSTEM
GE MEDICAL SYSTEMS, LLC           510(k) NO: K033502(TRADITIONAL)
ATTN: JOHN W JAECKLE              PHONE NO : 262-312-7358
3000 N. GRANDVIEW BLVD.           SE DECISION MADE: 20-NOV-03
WAUKESHA, WI 53188                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
GENERAL ELECTRIC CO.              510(k) NO: K033504(SPECIAL)
ATTN: LARRY A KROGER, PH.D.       PHONE NO : 262-544-3894
P.O. BOX 414                      SE DECISION MADE: 25-NOV-03
MILWAUKEE, WI 53201               510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM
GUIDANT CORP.                     510(k) NO: K033393(SPECIAL)
ATTN: KELLY  PIKE                 PHONE NO : 408-845-3000
3200 LAKESIDE DR.                 SE DECISION MADE: 10-NOV-03
SANTA CLARA, CA 95054             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS
GYRUS ENT L.L.C.                  510(k) NO: K033554(TRADITIONAL)
ATTN: GREGORY  SREDIN             PHONE NO : 901-373-0200
2925 APPLING RD.                  SE DECISION MADE: 24-NOV-03
BARTLETT, TN 38133                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GYRUS OPEN FORCEPS
GYRUS MEDICAL, INC.               510(k) NO: K024286(TRADITIONAL)
ATTN: MARK  JENSEN                PHONE NO : 763-416-3005
6655 WEDGWOOD ROAD, # 105         SE DECISION MADE: 17-NOV-03
MINNEAPOLIS, MN 55311-3602        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODEL
HAND BIOMECHANICS LAB, INC.       510(k) NO: K033112(TRADITIONAL)
ATTN: TIMOTHY R STALLINGS         PHONE NO : 916-923-5073
77 SCRIPPS DR., SUITE 104         SE DECISION MADE: 05-NOV-03
SACRAMENTO, CA 95825              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III
HK SURGICAL, INC.                 510(k) NO: K032802(ABBREVIATED)
ATTN: SALLY M BOWDON              PHONE NO : 800-909-0060
2620A TEMPLE HEIGHTS DR.          SE DECISION MADE: 19-NOV-03
OCEANSIDE, CA 92675               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER
HOLOGIC, INC.                     510(k) NO: K033224(SPECIAL)
ATTN: DANIEL F PHELAN             PHONE NO : 781-999-7300
35 CROSBY DR.                     SE DECISION MADE: 05-NOV-03
BEDFORD, MA 01730                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT
HORIZON MEDICAL PRODUCTS, INC.    510(k) NO: K033473(SPECIAL)
ATTN: SCOTT  MOELLER              PHONE NO : 800-472-5221
1 HORIZON WAY                     SE DECISION MADE: 18-NOV-03
MANCHESTER, GA 31816              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SCORPIO NRG KNEE SYSTEM
HOWMEDICA OSTEONICS CORP.         510(k) NO: K030978(TRADITIONAL)
ATTN: DENISE  DUCHENE             PHONE NO : 201-831-5612
59 ROUTE 17 SOUTH                 SE DECISION MADE: 20-NOV-03
ALLENDALE, NJ 07401               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HOFFMANN II PELVIC CLAMP
HOWMEDICA OSTEONICS CORP.         510(k) NO: K033145(TRADITIONAL)
ATTN: VIVIAN  KELLY               PHONE NO : 201-831-5581
59 ROUTE 17                       SE DECISION MADE: 05-NOV-03
ALLENDALE, NJ 07401-1677          510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050
IDEV TECHNOLOGIES, INC.           510(k) NO: K033188(TRADITIONAL)
ATTN: LYNNE A DAVIES              PHONE NO : 281-333-1998
1110 NASA RD., SUITE 311          SE DECISION MADE: 19-NOV-03
HOUSTON, TX 77058-3345            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12
IGC-MEDICAL ADVANCES, INC.        510(k) NO: K033292(TRADITIONAL)
ATTN: ANTHONY  DIETZLER           PHONE NO : 414-258-3808
10437 INNOVATION DR.              SE DECISION MADE: 26-NOV-03
MILWAUKEE, WI 53226               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMUNICON CELLTRACKS ANALYZER
IMMUNICON CORP.                   510(k) NO: K030263(TRADITIONAL)
ATTN: PETER  SCOTT                PHONE NO : 215-830-0777
3401 MASONS MILL RD. STE 100      SE DECISION MADE: 24-NOV-03
HUNTINGTON VALLEY, PA 19006-3574  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 3I TG OSSEOTITE IMPLANT, MODELS TG685, TG610, TG611, TG613, TG56
IMPLANT INNOVATIONS, INC.         510(k) NO: K033430(SPECIAL)
ATTN: TAMARA  NELSON              PHONE NO : 561-776-6923
4555 RIVERSIDE DR.                SE DECISION MADE: 07-NOV-03
PALM BEACH GARDENS, FL 33410      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-16
IMPLEX CORP.                      510(k) NO: K033384(SPECIAL)
ATTN: MARCI  HALEVI               PHONE NO : 201-818-1800
80 COMMERCE DR.                   SE DECISION MADE: 19-NOV-03
ALLENDALE, NJ 07401-1600          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAPHOSOL
INPHARMA A.S.                     510(k) NO: K030802(TRADITIONAL)
ATTN: BRUCE  MANNING              PHONE NO : 508-393-3100
96 WEST MAIN ST.                  SE DECISION MADE: 25-NOV-03
NORTHBOROUGH, MA 01532            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTERLAB IMMUNOFIXATION TEST(S)
INTERLAB S.R.L.                   510(k) NO: K033187(TRADITIONAL)
ATTN: GARY  LEHNUS                PHONE NO : 570-620-0198
150 CHERRY LANE RD.               SE DECISION MADE: 19-NOV-03
EAST STROUDSBURG, PA 18301-8804   510(k) STATEMENT

DEVICE: SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
INTRALUMINAL THERAPEUTICS, INC.   510(k) NO: K031842(TRADITIONAL)
ATTN: PAMELA  MISAJON             PHONE NO : 760-918-1820
6354 CORTE DEL ABETO              SE DECISION MADE: 21-NOV-03
SUITE A                           510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92009

DEVICE: ILT SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1
INTRALUMINAL THERAPEUTICS, INC.   510(k) NO: K032784(TRADITIONAL)
ATTN: PAMELA  MISAJON             PHONE NO : 760-918-1820
6354 CORTE DEL ABETO              SE DECISION MADE: 18-NOV-03
SUITE A                           510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92009

 
DEVICE: COMPACT DIGITAL CARDIAC CAMERA (CDCC)
IS2 MEDICAL SYSTEMS, INC.         510(k) NO: K033199(TRADITIONAL)
ATTN: VICTOR  WOODBURN            PHONE NO : 613 228 8755
20 GURDWARA ROAD                  SE DECISION MADE: 12-NOV-03
UNITS 3-10                        510(k) SUMMARY AVAILABLE FROM FDA
OTTAWA, ONTARIO, CANADA K2E 8B3

DEVICE: ENDO PAT 2000
ITAMAR MEDICAL LTD.               510(k) NO: K032519(TRADITIONAL)
ATTN: DORIT  WINITZ               PHONE NO : 972 977 18130
117 AHUZAH ST.                    SE DECISION MADE: 12-NOV-03
RA'ANANNA, ISRAEL 43373           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTILINK
IVOCLAR VIVADENT, INC.            510(k) NO: K032470(TRADITIONAL)
ATTN: DONNA M HARTNETT            PHONE NO : 716-691-0010
175 PINEVIEW DR.                  SE DECISION MADE: 05-NOV-03
AMHERST, NY 14228                 510(k) STATEMENT

DEVICE: JSA REPROCESSED COMPRESSION SLEEVE DEVICES
JACK SPEER AND ASSOC., INC.       510(k) NO: K031722(TRADITIONAL)
ATTN: JACK  SPEER                 PHONE NO : 801-582-6470
1800 EAST 900 SOUTH               SE DECISION MADE: 25-NOV-03
SLC, UT 84108                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004
KEELER INSTRUMENTS, INC.          510(k) NO: K032087(TRADITIONAL)
ATTN: EUGENE  VANARSDALE          PHONE NO : 610-353-4350
456 PKWY.                         SE DECISION MADE: 26-NOV-03
BROOMALL, PA 19008                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT A
KIMBERLY-CLARK CORP.              510(k) NO: K033021(TRADITIONAL)
ATTN: RICHARD V WOLFE             PHONE NO : 770-587-8208
1400 HOLCOMB BRIDGE RD.           SE DECISION MADE: 12-NOV-03
ROSWELL, GA 30076                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VER
KINGSWELL INTERNATIONAL INC.      510(k) NO: K032670(TRADITIONAL)
ATTN: D.C.  CHANG                 PHONE NO : 909-465-5769
264 CARBONIA AVE.                 SE DECISION MADE: 14-NOV-03
WALNUT, CA 91789                  510(k) STATEMENT

DEVICE: KD-726 MEMORY WRIST AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
KONDON (TIANJIN) ELECTRONIC & ELEC510(k) NO: K030359(TRADITIONAL)
ATTN: LIU  YI                     PHONE NO : 86 22 27470070
NO. 31 CHANGJIANG ROAD            SE DECISION MADE: 06-NOV-03
NANKAI DISTRICT                   510(k) SUMMARY AVAILABLE FROM FDA
TIANJIN, CHINA 300193

DEVICE: PANAVIA F 2.0
KURARAY MEDICAL INC.              510(k) NO: K032455(TRADITIONAL)
ATTN: SATOSHI  YAMAGUCHI          PHONE NO : 212-986-2230
101 EAST 52ND STREET, 26TH FL.    SE DECISION MADE: 07-NOV-03
NEW YORK, NY 10022                510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML
LABORATORIOS GRIFOLS, S.A.        510(k) NO: K031419(TRADITIONAL)
ATTN: SEBASTIAN  GASCON           PHONE NO : 34 935 710100
POL. LEVANTE C/CAN GUASCH, 2      SE DECISION MADE: 24-NOV-03
PARETS DEL VALLES, BARCELONA, SPAI510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: STAR (LUNAR SERIES) MONITORING SYSTEM
LARSEN & TOUBRO LIMITED           510(k) NO: K032867(TRADITIONAL)
ATTN: E.J.  SMITH                 PHONE NO : 410-451-0639
P.O. BOX 4341                     SE DECISION MADE: 10-NOV-03
CROFTON, MD 21114                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: PLANET MONITORING SYSTEM
LARSEN & TOUBRO LIMITED           510(k) NO: K032871(TRADITIONAL)
ATTN: E.J.  SMITH                 PHONE NO : 410-451-0639
P.O. BOX 4341                     SE DECISION MADE: 10-NOV-03
CROFTON, MD 21114                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: AURA ISURGICAL LASER SYSTEM & ACCESSORIES
LASERSCOPE                        510(k) NO: K024206(TRADITIONAL)
ATTN: PAUL  HARDIMAN              PHONE NO : 408-943-0636
3070 ORCHARD DR.                  SE DECISION MADE: 17-NOV-03
SAN JOSE, CA 95134-2011           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RENOVA INTERNAL HEX IMPLANT SYSTEM
LIFECORE BIOMEDICAL, INC.         510(k) NO: K032774(TRADITIONAL)
ATTN: DIANE  BRINZA               PHONE NO : 952-368-6394
3515 LYMAN BLVD.                  SE DECISION MADE: 26-NOV-03
CHASKA, MN 55318                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT#
LIN-ZHI INTERNATIONAL, INC.       510(k) NO: K032764(TRADITIONAL)
ATTN: CHENG-I  LIN                PHONE NO : 408-732-3856
687 NORTH PASTORIA AVE.           SE DECISION MADE: 03-NOV-03
SUNNYVALE, CA 94085-2917          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185
LINVATEC CORP.                    510(k) NO: K032607(TRADITIONAL)
ATTN: LAURA  KREJCI               PHONE NO : 727-399-5234
11311 CONCEPT BLVD.               SE DECISION MADE: 10-NOV-03
LARGO, FL 33773-4908              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LMT NOMAG IC 1,5
LMT LAMMERS MEDICAL TECHNOLOGY GMB510(k) NO: K033565(ABBREVIATED)
ATTN: THOMAS M BOHNEN             PHONE NO : 49 451 5809814
BESSEMERSTR. 7                    SE DECISION MADE: 21-NOV-03
LUEBECK, GERMANY 23562            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

 
DEVICE: POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE BR
LONG FIRST (XIAMEN) CO.,LTD.      510(k) NO: K031170(TRADITIONAL)
ATTN: STONE  CHEN                 PHONE NO : 886 075 612201
#23, KOOSHAN 3RD ROAD,            SE DECISION MADE: 13-NOV-03
KAOHSIUNG, CHINA (TAIWAN)         510(k) STATEMENT

DEVICE: MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED  SUCTION SYSTEM
MALLINCKRODT DAR S.R.L.           510(k) NO: K031997(TRADITIONAL)
ATTN: GIUSEPPE  TOMASINI          PHONE NO : 011 390 535617922
VIA G.BOVE, 2/4/6/8               SE DECISION MADE: 25-NOV-03
MIRANDOLA (MODENA), ITALY 41037   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MARINA MEDICAL SILICONE PESSARY
MARINA MEDICAL INSTRUMENTS, INC.  510(k) NO: K031463(TRADITIONAL)
ATTN: JAY  MANSOUR                PHONE NO : 770-777-4146
1308 MORNINGSIDE PARK DR.         SE DECISION MADE: 18-NOV-03
ALPHARETTA, GA 30022              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECTRO FLO PERCUSSOR, MODEL 5000
MED SYSTEMS                       510(k) NO: K031876(TRADITIONAL)
ATTN: DANIEL  KAMM                PHONE NO : 847-374-1727
PO BOX 7007                       SE DECISION MADE: 21-NOV-03
DEERFIELD, IL 60015               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STONE EXTRACTOR BALLOON CATHETER
MEDI-GLOBE CORP.                  510(k) NO: K011261(TRADITIONAL)
ATTN: SCOTT  KARLER               PHONE NO : 480-897-2772
6202 SOUTH MAPLE AVE.,            SE DECISION MADE: 17-NOV-03
SUITE 131                         510(k) SUMMARY AVAILABLE FROM FDA
TEMPE, AZ 85283

DEVICE: PASSMED SPINAL SYSTEM
MEDICREA                          510(k) NO: K032094(TRADITIONAL)
ATTN: J.D.  WEBB                  PHONE NO : 512-388-0199
1001 OAKWOOD BLVD                 SE DECISION MADE: 14-NOV-03
ROUND ROCK, TX 78681              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDICHEART, MODEL RELEASE 1
MEDICSIGHT                        510(k) NO: K032823(TRADITIONAL)
ATTN: CAROL  MACDONALD            PHONE NO : 440 207 5985351
46 BERKELEY SQUARE                SE DECISION MADE: 10-NOV-03
LONDON, UNITED KINGDOM W 1J 5AT   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDIC COLON MODEL, RELEASE 1
MEDICSIGHT                        510(k) NO: K033102(TRADITIONAL)
ATTN: CAROL  MACDONALD            PHONE NO : 440 207 5985751
46 BERKELEY SQUARE                SE DECISION MADE: 05-NOV-03
LONDON, UNITED KINGDOM W 1J 5AT   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BLOOD PRESSURE MONITOR, MODEL M100
MEDITEK TECHNOLOGY, INC.          510(k) NO: K032308(TRADITIONAL)
ATTN: TONY C.S.  CHANG            PHONE NO : 886 4 22972787
NO. 5, ALLEY 5, LN CHENG HSING    SE DECISION MADE: 10-NOV-03
CHUNG CHING RD.                   510(k) SUMMARY AVAILABLE FROM FDA
PEI TUN DIST., TAICHUNG, CHINA (TAIWAN)

 
DEVICE: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM
MEDRAD, INC.                      510(k) NO: K033247(SPECIAL)
ATTN: TROY A JACK                 PHONE NO : 412-767-2400
ONE MEDRAD DR.                    SE DECISION MADE: 05-NOV-03
INDIANOLA, PA 15051               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROFILE -ER
MEDTOX DIAGNOSTICS, INC.          510(k) NO: K033334(SPECIAL)
ATTN: ALAN  MORRIS                PHONE NO : 336-226-6311
1238 ANTHONY RD.                  SE DECISION MADE: 10-NOV-03
BURLINGTON, NC 27215              510(k) STATEMENT

DEVICE: SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SE
MEDTRONIC PERFUSION SYSTEMS       510(k) NO: K033416(SPECIAL)
ATTN: RONALD W BENNETT            PHONE NO : 763-391-9086
7611 NORTHLAND DR.                SE DECISION MADE: 05-NOV-03
BROOKLYN PARK, MN 55428           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE
MEDTRONIC PERFUSION SYSTEMS       510(k) NO: K033468(SPECIAL)
ATTN: MICHELE  PYFFEROEN          PHONE NO : 763-391-9136
7611 NORTHLAND DR.                SE DECISION MADE: 14-NOV-03
MINNEAPOLIS, MN 55428             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIFEPAK 12, 20, 500, CR PLUS
MEDTRONIC PHYSIO-CONTROL CORP.    510(k) NO: K033275(SPECIAL)
ATTN: MICHELLE  ACKERMANN         PHONE NO : 425-867-4744
11811 WILLOWS RD NE               SE DECISION MADE: 06-NOV-03
P.O. BOX 97006                    510(k) SUMMARY AVAILABLE FROM FDA
REDMOND, WA 98073-9706

DEVICE: DYNALOK CLASSIC SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK           510(k) NO: K033271(SPECIAL)
ATTN: RICHARD  TREHARNE           PHONE NO : 901-396-3133
1800 PYRAMID PLACE                SE DECISION MADE: 06-NOV-03
MEMPHIS, TN 38132                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CEDIA VANCOMYCIN ASSAY
MICROGENICS CORP.                 510(k) NO: K032811(TRADITIONAL)
ATTN: DAVID  CASAL                PHONE NO : 510-979-5012
46360 FREMONT BLVD.               SE DECISION MADE: 24-NOV-03
FREMONT, CA 94538                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100
MICROLIFE CORP.                   510(k) NO: K031024(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK      PHONE NO : 516-482-9001
55 NORTHERN BLVD.                 SE DECISION MADE: 14-NOV-03
SUITE 200                         510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021

DEVICE: SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2
MICRON CORP.                      510(k) NO: K032995(SPECIAL)
ATTN: TAKASHI  TERUI              PHONE NO : 81 3 37260396
1-34-14 HIGASHIYUKIGAYA           SE DECISION MADE: 20-NOV-03
OTA-KU, TOKYO, JAPAN 145-0065     510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: COLIBRI DISPOSABLE VITRECTOMY CUTTER
MICROWORLD MEDICAL INSTRUMENTS, IN510(k) NO: K033390(TRADITIONAL)
ATTN: SEMYON  GAMBARIN            PHONE NO : 510-534-7401
4640 MALAT ST.                    SE DECISION MADE: 04-NOV-03
OAKLAND, CA 94601                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MICRUS MICROCOIL SYSTEM
MICRUS CORP.                      510(k) NO: K032872(TRADITIONAL)
ATTN: MARGARET  WEBBER            PHONE NO : 408-830-5900
610 PALOMAR AVENUE                SE DECISION MADE: 28-NOV-03
MOUNTAIN VIEW, CA 94085           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881
MIELE, INC.                       510(k) NO: K031799(SPECIAL)
ATTN: STEVE  POLINSKI             PHONE NO : 609-419-9898
9 INDEPENDENCE WAY                SE DECISION MADE: 12-NOV-03
PRINCETON, NJ 08540               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PARADIGMPAL, MODEL MMT-7330
MINIMED, INC.                     510(k) NO: K031541(TRADITIONAL)
ATTN: GERDA P RESCH               PHONE NO : 818-362-5958
18000 DEVONSHIRE ST.              SE DECISION MADE: 18-NOV-03
NORTHRIDGE, CA 91325              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYDRAGEL CSF ISOFOCUSING KITS
MORAX                             510(k) NO: K033277(SPECIAL)
ATTN: BOREK  JANIK                PHONE NO : 734-475-2441
SUITE 400                         SE DECISION MADE: 04-NOV-03
1705 CORPORATE DRIVE              510(k) SUMMARY AVAILABLE FROM FDA
NORCROSS, GA 30093

DEVICE: MPS ACACIA SAFEGUARD HUBER DEVICE
MPS ACACIA                        510(k) NO: K032934(TRADITIONAL)
ATTN: FERGIE F FERGUSON           PHONE NO : 714-257-0470
499 NIBUS ST., SUITE E            SE DECISION MADE: 13-NOV-03
BREA, CA 92821                    510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS
MRI DEVICES CORP.                 510(k) NO: K033567(SPECIAL)
ATTN: THOMAS  SCHUBERT            PHONE NO : 262-524-1402
1515 PARAMOUNT DR.                SE DECISION MADE: 25-NOV-03
WAUKESHA, WI 53186                510(k) STATEMENT

DEVICE: ELECTRONIC MUSCLE MASSAGE, MODELS BE-550 AND BE-660
MULTINATIONAL                     510(k) NO: K031820(TRADITIONAL)
ATTN: GRACE  HOLLAND              PHONE NO : 949-262-0411
3722 AVE. SAUSALITO               SE DECISION MADE: 12-NOV-03
IRVINE, CA 92606                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHILEY FLEXTRA TRACHEOSTOMY TUBE
NELLCOR PURITAN BENNETT, INC.     510(k) NO: K030787(TRADITIONAL)
ATTN: GINA  TO                    PHONE NO : 925-463-4427
4280 HACIENDA DR.                 SE DECISION MADE: 14-NOV-03
PLEASANTON, CA 94588-2719         510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: SELECTIVA SB GUIDEWIRE
NEO METRICS, INC.                 510(k) NO: K033321(SPECIAL)
ATTN: MARK  PEDERSON              PHONE NO : 763-559-4440
14800 28TH AVENUE NORTH           SE DECISION MADE: 05-NOV-03
SUITE 150                         510(k) SUMMARY AVAILABLE FROM FDA
PLYMOUTH, MN 55447

DEVICE: MODIFICATION TO EN-BLOC BIOPSY SYSTEM
NEOTHERMIA CORP.                  510(k) NO: K033427(SPECIAL)
ATTN: SHERRIE  COVAL-GOLDSMITH    PHONE NO : 508-655-7820
ONE APPLE HILL                    SE DECISION MADE: 10-NOV-03
SUITE 316                         510(k) SUMMARY AVAILABLE FROM FDA
NATICK, MA 01760

DEVICE: MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE
NIPRO MEDICAL CORP.               510(k) NO: K032777(SPECIAL)
ATTN: RICHARD D BLISS             PHONE NO : 954-385-1690
510 STONEMONT DR.                 SE DECISION MADE: 14-NOV-03
WESTON, FL 33326                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERIOGLAS PLUS - SETTABLE BONE GRAFT SUBSTITUTE
NOVABONE PRODUCTS, LLC            510(k) NO: K031073(TRADITIONAL)
ATTN: DAVID M GAISSER             PHONE NO : 386-462-7660
ONE PROGRESS BLVD.                SE DECISION MADE: 05-NOV-03
SUITE 33                          510(k) SUMMARY AVAILABLE FROM FDA
ALACHUA, FL 32615

DEVICE: GE PRECISION MPI
NRT-NORDISK RONTGEN TEKNIK A/S    510(k) NO: K033486(TRADITIONAL)
ATTN: JAN  MALLING                PHONE NO : 458 628 3500
BIRKEGAARDSVEJ 16                 SE DECISION MADE: 19-NOV-03
HASSELAGER, DENMARK 8361          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: NUVASIVE MESH
NUVASIVE, INC.                    510(k) NO: K032476(SPECIAL)
ATTN: LAETITIA  BERNARD           PHONE NO : 858-229-9924
10065 OLD GROVE RD.               SE DECISION MADE: 13-NOV-03
SAN DIEGO, CA 92131               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NXSTAGE PUREFLOW SOLUTION
NXSTAGE MEDICAL, INC.             510(k) NO: K033386(SPECIAL)
ATTN: NORMA  LEMAY                PHONE NO : 978-687-4700
439 SOUTH UNION ST.               SE DECISION MADE: 26-NOV-03
SUITE 501                         510(k) SUMMARY AVAILABLE FROM FDA
LAWRENCE, MA 01843

DEVICE: ACCUMAP AUTOMATIC PERIMETER
OBJECTIVISION PTY LTD.            510(k) NO: K022304(TRADITIONAL)
ATTN: FRED  HENRY                 PHONE NO : 484-679-2400
185 JORDAN RD.                    SE DECISION MADE: 14-NOV-03
TROY, NY 12180                    510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C C
OLYMPUS AMERICA, INC.             510(k) NO: K031380(TRADITIONAL)
ATTN: MICHAEL  CAMPBELL           PHONE NO : 972-556-9697
3131 WEST ROYAL LN.               SE DECISION MADE: 14-NOV-03
IRVING, TX 75063-3104             510(k) STATEMENT

DEVICE: OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071
OLYMPUS AMERICA, INC.             510(k) NO: K032665(ABBREVIATED)
ATTN: MICHAEL  CAMPBELL           PHONE NO : 972-556-9697
3131 WEST ROYAL LN.               SE DECISION MADE: 21-NOV-03
IRVING, TX 75063-3104             510(k) STATEMENT

DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRA
ORTHO-CLINICAL DIAGNOSTICS, INC.  510(k) NO: K033300(TRADITIONAL)
ATTN: CHARLOTTE  BAKER            PHONE NO : 585-453-3730
100 INDIGO CREEK DR.              SE DECISION MADE: 05-NOV-03
ROCHESTER, NY 14626-5101          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITOSS-FILLED CARTRIDGE
ORTHOVITA, INC.                   510(k) NO: K032130(SPECIAL)
ATTN: ANDREINA ANGIE  IDE         PHONE NO : 610-407-5231
45 GREAT VALLEY PKWY.             SE DECISION MADE: 05-NOV-03
MALVERN, PA 19355                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEM
OSTEOMED L.P.                     510(k) NO: K031708(TRADITIONAL)
ATTN: DAWN T HOLDERMAN            PHONE NO : 972-677-4600
3885 ARAPAHO RD.                  SE DECISION MADE: 03-NOV-03
ADDISON, TX 75001                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PASCO MIC AND MIC/ID PANELS
PASCO LABORATORIES, INC.          510(k) NO: K033119(TRADITIONAL)
ATTN: LINDA E DILLON              PHONE NO : 303-390-3240
12750 WEST 42ND AVE.              SE DECISION MADE: 18-NOV-03
WHEAT RIDGE, CO 80033             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GLUCOSE TOLERANCE BEVERAGE
PERK SCIENTIFIC, INC.             510(k) NO: K032753(TRADITIONAL)
ATTN: MARK  BARTOSH               PHONE NO : 610-259-1009
520 COMMERCE DR.                  SE DECISION MADE: 18-NOV-03
YEADON, PA 19050                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE
PETER M. ROTHENBERG, M.D.         510(k) NO: K032613(TRADITIONAL)
ATTN: PETER M ROTHENBERG          PHONE NO : 949-489-9039
657 CAMINO DE LOS MARES           SE DECISION MADE: 20-NOV-03
SUITE 137                         510(k) SUMMARY AVAILABLE FROM FDA
SAN CLEMENTE, CA 92673

DEVICE: PHILIPS MEDICAL SYSTEMS, M3012A- HEMODYNAMIC EXTENSION TO THE MU
PHILIPS MEDICAL SYSTEMS           510(k) NO: K033444(SPECIAL)
ATTN: TAPAN D SHAH                PHONE NO : 978-659-7681
3000 MINUTEMAN RD.                SE DECISION MADE: 21-NOV-03
ANDOVER, MA 01810-1099            510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) A
PLAYTEX PRODUCTS, INC.            510(k) NO: K032636(TRADITIONAL)
ATTN: KAREN A COSTA               PHONE NO : 201-785-8090
75 COMMERCE DR.                   SE DECISION MADE: 14-NOV-03
ALLENDALE, NJ 07401               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERI
PORTEX LTD.                       510(k) NO: K032716(TRADITIONAL)
ATTN: STEVE  OGILVIE              PHONE NO : 00 440 1303260551
MILITARY ROAD                     SE DECISION MADE: 28-NOV-03
HYTHE, KENT, UNITED KINGDOM CT 21 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRYOCHECK WEAK LUPUS POSITIVE CONTROL
PRECISION BIOLOGIC                510(k) NO: K032804(TRADITIONAL)
ATTN: STEPHEN  DUFF               PHONE NO : 902 468 6422
900 WINDMILL RD., SUITE 100       SE DECISION MADE: 03-NOV-03
DARTMOUTH, N.S., CANADA B3B 1P7   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON
PRO-MED INSTRUMENTS GMBH          510(k) NO: K032331(TRADITIONAL)
ATTN: JIM  BAZZINOTTI             PHONE NO : 239-225-4086
1899 SAWYER LANE                  SE DECISION MADE: 20-NOV-03
ALVA, FL 33920                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARAMIS II DERMATOLOGICAL LASER
QUANTEL MEDICAL                   510(k) NO: K032260(TRADITIONAL)
ATTN: ROGER W BARNES              PHONE NO : 501-525-8612
342 SUNSET BAY RD.                SE DECISION MADE: 20-NOV-03
HOT SPRINGS, AR 71913             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUASAR, MODEL MD21
QUANTUM SKINCARE, INC.            510(k) NO: K032379(TRADITIONAL)
ATTN: J. HARVEY  KNAUSS           PHONE NO : 832-285-9423
11874 SOUTH EVELYN CIRCLE         SE DECISION MADE: 20-NOV-03
HOUSTON, TX 77071                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RELIANT LASER SYSTEM
RELIANT TECHNOLOGIES, INC.        510(k) NO: K031795(TRADITIONAL)
ATTN: HEATHER  TANNER             PHONE NO : 650-473-0200
260 SHERIDAN AVE.                 SE DECISION MADE: 10-NOV-03
PALO ALTO, CA 94306               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY
REMEL INC                         510(k) NO: K031834(TRADITIONAL)
ATTN: EARLEEN C PARKS             PHONE NO : 913-895-4185
12076 SANTA FE DRIVE              SE DECISION MADE: 10-NOV-03
LENEXA, KS 66215                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020
REMEL INC                         510(k) NO: K031942(TRADITIONAL)
ATTN: RICHARD  TYSON              PHONE NO : 763-712-2347
1400 UNITY ST. NORTHWEST          SE DECISION MADE: 18-NOV-03
RAMSEY, MN 55303                  510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020
REMEL INC                         510(k) NO: K031965(TRADITIONAL)
ATTN: RICHARD  TYSON              PHONE NO : 763-712-2347
1400 UNITY ST. NORTHWEST          SE DECISION MADE: 14-NOV-03
RAMSEY, MN 55303                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES
RENU MEDICAL, INC.                510(k) NO: K031559(TRADITIONAL)
ATTN: L. BRUCE  PIERSON           PHONE NO : 425-353-1110
9800 EVERGREEN WAY                SE DECISION MADE: 12-NOV-03
EVERETT, WA 98204                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PLV CONTINUUM VENTILATOR, MODEL P1000
RESPIRONICS CALIFORNIA, INC.      510(k) NO: K022750(TRADITIONAL)
ATTN: MARY  FUNK                  PHONE NO : 760-918-7300
2271 COSMOS CT.                   SE DECISION MADE: 20-NOV-03
CARLSBAD, CA 92009                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HOSPITAL SPACER
RESPIRONICS HEALTHSCAN, INC.      510(k) NO: K032809(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK      PHONE NO : 480-451-7502
55 NORTHERN BLVD.,                SE DECISION MADE: 13-NOV-03
SUITE 200                         510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021              THIRD PARTY REVIEW

DEVICE: MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100
REVIVANT CORP.                    510(k) NO: K032852(SPECIAL)
ATTN: BOB H KATZ                  PHONE NO : 408-524-3500
775 PALOMAR AVE.                  SE DECISION MADE: 12-NOV-03
SUNNYVALE, CA 94085               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECSYS PROBNP IMMUNOASSAY
ROCHE DIAGNOSTICS CORP.           510(k) NO: K032646(TRADITIONAL)
ATTN: KAY A TAYLOR                PHONE NO : 317-521-3544
9115 HAGUE RD.                    SE DECISION MADE: 12-NOV-03
INDIANAPOLIS, IN 46256            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)
ROCHE DIAGNOSTICS CORP.           510(k) NO: K033501(SPECIAL)
ATTN: SHERRI L COENEN             PHONE NO : 317-521-3831
9115 HAGUE RD.                    SE DECISION MADE: 20-NOV-03
INDIANAPOLIS, IN 46250            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
ROCHE DIAGNOSTICS CORP.           510(k) NO: K033548(SPECIAL)
ATTN: JENNIFER  TRIBBETT          PHONE NO : 317-521-3742
9115 HAGUE RD.                    SE DECISION MADE: 24-NOV-03
INDIANAPOLIS, IN 46250            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUTO-BAND LIGATOR
SCANDIMED. A.S.                   510(k) NO: K031236(TRADITIONAL)
ATTN: KRISTIAN K JENSEN           PHONE NO : 454 492 6444
SLOTSHERRENSVEJ 409               SE DECISION MADE: 14-NOV-03
GLOSTROP, DENMARK DK 2600         510(k) STATEMENT

 
DEVICE: PROFILE BBL SYSTEM
SCITON, INC.                      510(k) NO: K032460(TRADITIONAL)
ATTN: JAY M PATEL                 PHONE NO : 650-493-9155
845 COMMERCIAL ST.                SE DECISION MADE: 13-NOV-03
PALO ALTO, CA 94303               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UCR SPINAL SYSTEM
SEASPINE                          510(k) NO: K032739(SPECIAL)
ATTN: DIANA  SMITH                PHONE NO : 619-251-9132
727 PARK BLVD.                    SE DECISION MADE: 20-NOV-03
SAN DIEGO, CA 92101               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PLASTALGIN AND PLASTALGIN ORTHO
SEPTODONT                         510(k) NO: K032708(TRADITIONAL)
ATTN: WAYNE H MATELSKI, ESQ.      PHONE NO : 202-857-6340
1050 CONNECTICUT AVE., NW         SE DECISION MADE: 20-NOV-03
WASHINGTON, DC 20036              510(k) STATEMENT

DEVICE: NON-STERILE POWDER FREE GREEN LATEX PATIENT EXAM GLOVES WITH SUR
SGMP CO., LTD.                    510(k) NO: K023537(TRADITIONAL)
ATTN: JANNA P TUCKER              PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD        SE DECISION MADE: 20-NOV-03
SPARKS, NV 89434                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
SHEN WEI (USA), INC.              510(k) NO: K030583(TRADITIONAL)
ATTN: BELLE L CHOU                PHONE NO : 510-429-8692
2845 WHIPPLE RD.                  SE DECISION MADE: 10-NOV-03
UNION CITY, CA 94587              510(k) STATEMENT

DEVICE: FUGUAN (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG FUGUAN PLASTIC PRODUC510(k) NO: K032907(TRADITIONAL)
ATTN: CHEN  YUHONG                PHONE NO : 861 065 666660125
RM. 707, AVIC BLDG., NO.2         SE DECISION MADE: 20-NOV-03
DONG SAN HUAN NAN ROAD            510(k) SUMMARY AVAILABLE FROM FDA
CHAOYANG DISTRICT; BEIJING, CHINA 100022

DEVICE: FUGUAN (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG FUGUAN PLASTIC PRODUC510(k) NO: K032908(TRADITIONAL)
ATTN: CHEN  YUHONG                PHONE NO : 861 065 666660125
RM. 707, AVIC BLDG., NO.2         SE DECISION MADE: 20-NOV-03
DONG SAN HUAN NAN ROAD            510(k) SUMMARY AVAILABLE FROM FDA
CHAOYANG DISTRICT; BEIJING, CHINA 100022

DEVICE: LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
SIEMENS AG, MEDICAL SOLUTIONS     510(k) NO: K033374(SPECIAL)
ATTN: RUDIGER  KORNER             PHONE NO : 499 191 189355
SIEMENSSTRASSE 1                  SE DECISION MADE: 06-NOV-03
FORCHHEIM, GERMANY D 91301        510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND S
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K031340(TRADITIONAL)
ATTN: PENELOPE H GRECO            PHONE NO : 978-907-7500
16 ELECTRONICS AVE.               SE DECISION MADE: 25-NOV-03
DANVERS, MA 01923                 510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: SOMATON COMPUTED TOMOGRAPHY X-RAY SYSTEMS SLIDING GANTRY OPTION
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K032475(ABBREVIATED)
ATTN: NEALIE  HARTMAN             PHONE NO : 610-448-1769
51 VALLEY STREAM PKWY.            SE DECISION MADE: 10-NOV-03
MALVERN, PA 19355                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K032536(ABBREVIATED)
ATTN: NEALIE K HARTMAN            PHONE NO : 610-481-1769
51 VALLEY STREAM PKWY.            SE DECISION MADE: 10-NOV-03
MALVERN, PA 19355                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K033335(SPECIAL)
ATTN: DEBBIE  PEACOCK             PHONE NO : 610-448-1773
51 VALLEY STREAM PKWY.            SE DECISION MADE: 25-NOV-03
MALVERN, PA 19355                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOBILETTE XP AND MOBILETT XPHYBRID
SIEMENS MEDICAL SYSTEMS, INC.     510(k) NO: K033238(SPECIAL)
ATTN: NEALIE  HARTMAN             PHONE NO : 610-448-1769
51 VALLEY STREAM PARKWAY          SE DECISION MADE: 14-NOV-03
MALVERN, PA 19355                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RAINBOW GT-4A PAIN RELIEF MACHINE
SINO-US INFORMATION, INC          510(k) NO: K031546(TRADITIONAL)
ATTN: YITANG  SHENG               PHONE NO : 718-846-6868
85-13 88TH AVE.                   SE DECISION MADE: 13-NOV-03
WOODHAVEN, NY 11421               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES
SIRONA DENTAL SYSTEMS GMBH        510(k) NO: K032543(TRADITIONAL)
ATTN: MARY  MCNAMARA-CULLINANE    PHONE NO : 508-643-0434
49 PLAIN ST.                      SE DECISION MADE: 14-NOV-03
NORTH ATTLEBORO, MA 02760-4153    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REFLECTION CONSTRAINED LINER
SMITH & NEPHEW, INC.              510(k) NO: K033442(SPECIAL)
ATTN: KANU  VADODARIA             PHONE NO : 901-399-6261
1450 E. BROOKS RD.                SE DECISION MADE: 26-NOV-03
MEMPHIS, TN 38116                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO VERSABOND BONE CEMENT
SMITH & NEPHEW, INC.              510(k) NO: K033509(SPECIAL)
ATTN: DAVID  HENLEY               PHONE NO : 901-399-5153
1450 E. BROOKS RD.                SE DECISION MADE: 28-NOV-03
MEMPHIS, TN 38116                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PASCAL DYNAMIC CONTOUR TONOMETER
SMT SWISS MICROTECHNOLOGY AG      510(k) NO: K032967(TRADITIONAL)
ATTN: KEVIN  WALLS                PHONE NO : 720-962-5412
13 RED FOX LANE                   SE DECISION MADE: 14-NOV-03
LITTLETON, CO 80127               510(k) STATEMENT

 
DEVICE: TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEM, 18
SONOSITE,INC.                     510(k) NO: K033367(TRADITIONAL)
ATTN: MICHAEL A HOFFMAN           PHONE NO : 425-951-1297
21919 30TH DRIVE SE.              SE DECISION MADE: 05-NOV-03
BOTHELL, WA 98021-3904            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: AMBIT CONTINUOUS AMBULATORY INFUSION PUMP
SORENSON MEDICAL, INC.            510(k) NO: K033325(SPECIAL)
ATTN: DOUGLAS  BUESCHEL           PHONE NO : 801-352-6267
1375 WEST 8040 SOUTH              SE DECISION MADE: 06-NOV-03
WEST JORDAN, UT 84088-8320        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMBIT INTERMITTENT AMBULATORY INFUSION PUMP
SORENSON MEDICAL, INC.            510(k) NO: K033425(SPECIAL)
ATTN: DOUGLAS  BUESCHEL           PHONE NO : 801-352-6267
1375 WEST 8040 SOUTH              SE DECISION MADE: 06-NOV-03
WEST JORDAN, UT 84088-8320        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEUROLASE, MODELS 150V, 150C, 1064
SPECTRUM LASER & TECHNOLOGIES     510(k) NO: K032787(TRADITIONAL)
ATTN: THOMAS R RADEBAUGH          PHONE NO : 719-264-7632
4980 A CENTENNIAL BLVD.           SE DECISION MADE: 20-NOV-03
COLORADO SPRINGS, CO 80919        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GOOD MORNING TEST
STANDARD DIAGNOSTICS, INC.        510(k) NO: K031798(TRADITIONAL)
ATTN: RICHARD C LANZILLOTTO       PHONE NO : 631-744-0059
30 NORTHPORT ROAD                 SE DECISION MADE: 12-NOV-03
SOUND BEACH, NY 11789-1734        510(k) STATEMENT

DEVICE: STELKAST UNICONDYLAR KNEE SYSTEM
STELKAST COMPANY                  510(k) NO: K032824(TRADITIONAL)
ATTN: DONALD  STEVENS             PHONE NO : 724-941-6368
200 HIDDEN VALLEY ROAD            SE DECISION MADE: 13-NOV-03
MCMURRAY, PA 15317                510(k) STATEMENT

DEVICE: MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
STRYKER ENDOSCOPY                 510(k) NO: K033252(SPECIAL)
ATTN: MELISSA  MURPHY             PHONE NO : 408-754-2148
5900 OPTICAL CT.                  SE DECISION MADE: 13-NOV-03
SAN JOSE, CA 95138                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE
STRYKER INSTRUMENTS               510(k) NO: K032473(TRADITIONAL)
ATTN: ROBIN L ROWE                PHONE NO : 269-323-7700
4100 EAST MILHAM AVE.             SE DECISION MADE: 07-NOV-03
KALAMAZOO, MI 49001               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUMMIT STAIRWAY LIFT
SUMMIT LIFTS, INC.                510(k) NO: K032880(ABBREVIATED)
ATTN: KENT  PERRY                 PHONE NO : 913-498-1700
7300 W. 110TH STREET              SE DECISION MADE: 10-NOV-03
SUITE 260                         510(k) SUMMARY AVAILABLE FROM FDA
OVERLAND PARK, KS 66210

 
DEVICE: CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000
SURGITECH, INC.                   510(k) NO: K033358(TRADITIONAL)
ATTN: CHRISTOPHER  CROWELL        PHONE NO : 760-450-0194
2424 VISTA WAY, SUITE 300         SE DECISION MADE: 14-NOV-03
OCEANSIDE, CA 92054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PREMISE
SYBRON DENTAL SPECIALTIES, INC.   510(k) NO: K032921(TRADITIONAL)
ATTN: COLLEEN  BOSWELL            PHONE NO : 714-516-7484
1717 W. COLLINS AVE.              SE DECISION MADE: 13-NOV-03
ORANGE, CA 92867                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
SYNERGETICS, INC.                 510(k) NO: K032598(TRADITIONAL)
ATTN: DAN  REGAN                  PHONE NO : 636-939-5100
3845 CORPORATE CENTRE DR.         SE DECISION MADE: 24-NOV-03
ST. CHARLES, MO 63304             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLICK'X MONOAXIAL SCREWS AND HOOKS
SYNTHES (USA)                     510(k) NO: K031175(TRADITIONAL)
ATTN: JOHN  WALSH                 PHONE NO : 484-356-9621
1690 RUSSELL RD.                  SE DECISION MADE: 14-NOV-03
PAOLI, PA 19301                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM
SYNTHES (USA)                     510(k) NO: K033071(TRADITIONAL)
ATTN: LISA M BOYLE                PHONE NO : 610-647-9700
1690 RUSSELL RD.                  SE DECISION MADE: 05-NOV-03
PAOLI, PA 19301                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES
SYNTHES (USA)                     510(k) NO: K033158(TRADITIONAL)
ATTN: ANGLELA J SILVESTRI         PHONE NO : 610-647-9700
1690 RUSSELL RD.                  SE DECISION MADE: 05-NOV-03
PAOLI, PA 19301                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WI
SYNTHES (USA)                     510(k) NO: K033411(SPECIAL)
ATTN: BONNIE  SMITH               PHONE NO : 610-647-9700
1690 RUSSELL RD.                  SE DECISION MADE: 26-NOV-03
PAOLI, PA 19301                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TAIWAN KING STRONG POWERED WHEELCHAIR, TP 02
TAIWAN KING STRONG CO., LTD.      510(k) NO: K033097(TRADITIONAL)
ATTN: JEN  KE-MIN                 PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST.              SE DECISION MADE: 12-NOV-03
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) STATEMENT

DEVICE: GIARDIA II
TECHLAB, INC.                     510(k) NO: K033274(SPECIAL)
ATTN: DAVID M LYERLY              PHONE NO : 540-953-1664
1861 PRATT DR., STE. 1030         SE DECISION MADE: 04-NOV-03
BLACKSBURG, VA 24060-6364         510(k) STATEMENT

 
DEVICE: ORTRAUTEK TRAUMA SYSTEM
TEKKA                             510(k) NO: K032520(TRADITIONAL)
ATTN: FAYYAZ  MEMON               PHONE NO : 301-263-0544
6512 BANNOCKBURN DRIVE            SE DECISION MADE: 12-NOV-03
BETHESDA, MD 20817                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRIHA +
TEKNIMED SA                       510(k) NO: K031826(TRADITIONAL)
ATTN: J. D WEBB                   PHONE NO : 512-388-0199
1001 OAKWOOD BLVD                 SE DECISION MADE: 28-NOV-03
ROUNDROCK, TX 78681               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CEMSTOP CEMENT RESTRICTOR
TEKNIMED SA                       510(k) NO: K032685(TRADITIONAL)
ATTN: J.D.  WEBB                  PHONE NO : 512-388-0199
1001 OAKWOOD BLVD                 SE DECISION MADE: 26-NOV-03
ROUND ROCK, TX 78681              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHODEK
TELEFLEX MEDICAL                  510(k) NO: K033115(TRADITIONAL)
ATTN: STEPHEN  PAGE               PHONE NO : 508-677-6600
600 AIRPORT RD.                   SE DECISION MADE: 17-NOV-03
FALL RIVER, MA 02720-4740         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RHYTHM DIGITAL ELECTRONIC STETHOSCOPE
THINKLABS INC.                    510(k) NO: K032230(TRADITIONAL)
ATTN: RICHARD  LANZILLOTTO        PHONE NO : 631-744-0059
30 NORTHPORT ROAD                 SE DECISION MADE: 26-NOV-03
SOUND BEACH, NY 11789             510(k) STATEMENT

DEVICE: SPI EASY DENTAL IMPLANT PROTECTIVE CAP
THOMMEN MEDICAL, AG               510(k) NO: K033346(SPECIAL)
ATTN: FLOYD G LARSON              PHONE NO : 858-792-1235
4329 GRAYDON RD.                  SE DECISION MADE: 03-NOV-03
SAN DIEGO, CA 92130               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TLC MODELS ULK-H AND ULT-H INFRARED LAMPS
TLC MARKETING, INC.               510(k) NO: K033035(TRADITIONAL)
ATTN: ROBERT  MAZZAFERRO          PHONE NO : 301-216-2720
11 DELLCASTLE COURT               SE DECISION MADE: 20-NOV-03
MONTGOMERY VILLAGE, MD 20886      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO: HI-ART SYSTEM
TOMOTHERAPY INCORPORATED          510(k) NO: K033347(SPECIAL)
ATTN: KENNETH D BUROKER           PHONE NO : 608-824-2811
1240 DEMING WAY                   SE DECISION MADE: 12-NOV-03
MADISON, WI 53717                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K033418(TRADITIONAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714-730-5000
2441 MICHELLE DR.                 SE DECISION MADE: 10-NOV-03
P.O. BOX 2068                     510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068             THIRD PARTY REVIEW

 
DEVICE: LEGIONELLA PNEUMOPHILA IGG/IGM
TRINITY BIOTECH USA               510(k) NO: K033051(TRADITIONAL)
ATTN: BONNIE  DEJOY               PHONE NO : 716-483-3851
P.O. BOX 1059                     SE DECISION MADE: 26-NOV-03
JAMESTOWN, NY 14702-1059          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MYCOPLASMA IGG
TRINITY BIOTECH USA               510(k) NO: K033064(TRADITIONAL)
ATTN: BONNIE B DEJOY              PHONE NO : 716-483-3851
P.O. BOX 1059                     SE DECISION MADE: 26-NOV-03
JAMESTOWN, NY 14702-1059          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PYLORI IGG
TRINITY BIOTECH USA               510(k) NO: K033067(TRADITIONAL)
ATTN: BONNIE B DEJOY              PHONE NO : 716-483-3851
P.O. BOX 1059                     SE DECISION MADE: 26-NOV-03
JAMESTOWN, NY 14702-1059          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM
TRINITY BIOTECH USA               510(k) NO: K033070(TRADITIONAL)
ATTN: BONNIE B DEJOY              PHONE NO : 716-483-3851
P.O. BOX 1059                     SE DECISION MADE: 26-NOV-03
JAMESTOWN, NY 14702-1059          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHLAMYDIA IGG ELISA TEST SYSTEM
TRINITY BIOTECH USA               510(k) NO: K033079(TRADITIONAL)
ATTN: BONNIE B DEJOY              PHONE NO : 716-483-3851
P.O. BOX 1059                     SE DECISION MADE: 26-NOV-03
JAMESTOWN, NY 14702-1059          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
TRINITY BIOTECH USA               510(k) NO: K033083(TRADITIONAL)
ATTN: BONNIE B DEJOY              PHONE NO : 716-483-3851
P.O. BOX 1059                     SE DECISION MADE: 26-NOV-03
JAMESTOWN, NY 14702-1059          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HERPES GROUP IGG
TRINITY BIOTECH, INC.             510(k) NO: K033059(TRADITIONAL)
ATTN: BONNIE  DEJOY               PHONE NO : 716-483-3851
PO BOX 1059                       SE DECISION MADE: 26-NOV-03
JAMESTOWN, NY 14702               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S600
TUNG KENG ENTERPRISE CO., LTD.    510(k) NO: K033219(TRADITIONAL)
ATTN: JEN  KE-MIN                 PHONE NO : 886 3 5208829
NO. 58 FU-CHIUN ST.               SE DECISION MADE: 12-NOV-03
HSIN-CHU CITY, CHINA (TAIWAN) 427 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500
TUNG KENG ENTERPRISE CO., LTD.    510(k) NO: K033239(TRADITIONAL)
ATTN: KE-MIN  JEN                 PHONE NO : 886 3 5208829
NO. 58 FU-CHIUN ST.               SE DECISION MADE: 12-NOV-03
HSIN-CHU CITY, CHINA (TAIWAN) 427 510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S320
TUNG KENG ENTERPRISE CO., LTD.    510(k) NO: K033241(TRADITIONAL)
ATTN: KE-MIN  JEN                 PHONE NO : 886 3 5208829
NO. 58 FU-CHIUN ST.               SE DECISION MADE: 10-NOV-03
HSIN-CHU CITY, CHINA (TAIWAN) 427 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MONOJECT INSULIN SYRINGE
TYCO HEALTHCARE                   510(k) NO: K033373(SPECIAL)
ATTN: DAVID  OLSON                PHONE NO : 508-261-8530
15 HAMPSHIRE ST.                  SE DECISION MADE: 13-NOV-03
MANSFIELD, MA 02048               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRADENT CITRIC ACID 10% SOLUTION
ULTRADENT PRODUCTS, INC.          510(k) NO: K032627(TRADITIONAL)
ATTN: PETER  ALLRED               PHONE NO : 800-552-5512
505 WEST 10200 SOUTH              SE DECISION MADE: 12-NOV-03
SOUTH JORDAN, UT 84095            510(k) STATEMENT

DEVICE: CAPROSYN ABSORBABLE SUTURE
UNITED STATES SURGICAL, A DIVISION510(k) NO: K032586(ABBREVIATED)
ATTN: ROBERT  ZOTT                PHONE NO : 203-845-4515
150 GLOVER AVE.                   SE DECISION MADE: 17-NOV-03
NORWALK, CT 06856                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GROWTH GUIDANCE PLATE
UNIVERSITY OF UTAH/SCHOOL OF MEDIC510(k) NO: K031493(TRADITIONAL)
ATTN: PETER M STEVENS             PHONE NO : 801-588-3900
P.O. BOX #58246                   SE DECISION MADE: 20-NOV-03
SALT LAKE CITY, UT 84158          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG
UNOTECH DIAGNOSTICS, INC.         510(k) NO: K032987(TRADITIONAL)
ATTN: KEN  WU                     PHONE NO : 510-352-3070
2235 POLVOROSA AVE., SUITE 220    SE DECISION MADE: 17-NOV-03
SAN LEANDRO, CA 94577             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY
USA INSTRUMENTS, INC.             510(k) NO: K033353(SPECIAL)
ATTN: CHRISTIE  SHUMAKER          PHONE NO : 330-995-8572
1515 DANNER DR.                   SE DECISION MADE: 14-NOV-03
AURORA, OH 44202                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MALIS IRRIGATION MODULE 1000
VALLEY FORGE SCIENTIFIC CORP.     510(k) NO: K033499(SPECIAL)
ATTN: JERRY L MALIS               PHONE NO : 610-666-7500
136 GREEN TREE RD., STE. 100      SE DECISION MADE: 28-NOV-03
PO BOX 1179                       510(k) SUMMARY AVAILABLE FROM FDA
OAKS, PA 19456

DEVICE: GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER
VARIAN MEDICAL SYSTEMS, INC.      510(k) NO: K031524(TRADITIONAL)
ATTN: VY  TRAN                    PHONE NO : 650-424-5731
3100 HANSEN WAY                   SE DECISION MADE: 26-NOV-03
PALO ALTO, CA 94304-1129          510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE
VASCULAR SOLUTIONS, INC.          510(k) NO: K033237(TRADITIONAL)
ATTN: DEBORAH L JENSEN            PHONE NO : 763-656-4349
6464 SYCAMORE COURT               SE DECISION MADE: 20-NOV-03
MINNEAPOLIS, MN 55369             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPIROPRO SPO2
VIASYS HEALTHCARE GMBH            510(k) NO: K031515(TRADITIONAL)
ATTN: EARL  DRAPER                PHONE NO : 714-283-2228
22705 SAVI RANCH PKWY.            SE DECISION MADE: 14-NOV-03
YORBA LINDA, CA 92887             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIATRONIX V3D VASCULAR, REVISION 1.0
VIATRONIX, INC.                   510(k) NO: K033361(TRADITIONAL)
ATTN: FRANK  DACHILLE             PHONE NO : 631-444-6759
25 EAST LOOP RD., SUITE 204       SE DECISION MADE: 05-NOV-03
STONY BROOK, NY 11790             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: VITERION 100 TELEHEALTH MONITOR
VITERION TELEHEALTHCARE LLC       510(k) NO: K030419(TRADITIONAL)
ATTN: SEAN M CURRY                PHONE NO : 858-675-8200
16787 BERNARDO CENTER DR.         SE DECISION MADE: 06-NOV-03
SUITE A-1                         510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92128-2504

DEVICE: GRANDIO FLOW
VOCO GMBH                         510(k) NO: K033117(TRADITIONAL)
ATTN: GERALD W SHIPPS             PHONE NO : 541-389-5935
19379 BLUE LAKE LOOP              SE DECISION MADE: 25-NOV-03
BEND, OR 97702                    510(k) STATEMENT

DEVICE: GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
W. L. GORE & ASSOCIATES, INC.     510(k) NO: K032865(TRADITIONAL)
ATTN: MIKE  JOHNSON               PHONE NO : 928-864-3615
3450 WEST KILTIE LN.              SE DECISION MADE: 28-NOV-03
FLAGSTAFF, AZ 86002               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BESTALOY
WE DONG MYUNG DENTAL INDUSTRIAL CO510(k) NO: K033434(TRADITIONAL)
ATTN: RONALD D ARKIN              PHONE NO : 770-565-6166
1733 CANTON LN.                   SE DECISION MADE: 12-NOV-03
MARIETTA, GA 30062                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: E-SARANG 86, DM78, DM55
WE DONG MYUNG DENTAL INDUSTRIAL CO510(k) NO: K033435(TRADITIONAL)
ATTN: RONALD D ARKIN              PHONE NO : 770-565-6166
1733 CANTON LN.                   SE DECISION MADE: 12-NOV-03
MARIETTA, GA 30062                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

 
DEVICE: APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG
WE DONG MYUNG DENTAL INDUSTRIAL CO510(k) NO: K033446(TRADITIONAL)
ATTN: RONALD D ARKIN              PHONE NO : 770-565-6166
1733 CANTON LN.                   SE DECISION MADE: 13-NOV-03
MARIETTA, GA 30062                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ORTHOSPHERE CERAMIC SPHERICAL IMPLANT
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K030319(ABBREVIATED)
ATTN: KATIE  LOGEROT              PHONE NO : 901-867-4476
5677 AIRLINE RD.                  SE DECISION MADE: 26-NOV-03
ARLINGTON, TN 38002               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALOETOUCH POWDER FREE NEOPRENE SURGICAL GLOVES, STERILE, TURQUOI
WRP ASIA PACIFIC SDN. BHD.        510(k) NO: K032647(TRADITIONAL)
ATTN: TERENCE  LIM                PHONE NO : 60 03 87061486
LOT1,JALAN3,KAWASAN PERUSAHAAN    SE DECISION MADE: 07-NOV-03
BANDAR BARU SALAK TINGGI          510(k) SUMMARY AVAILABLE FROM FDA
SEPANG,SELANGOR DARUL EHSAN, MALAYSIA 43900

DEVICE: WU'S 4-WHEELED SCOOTER, WT-L4JR
WU'S TECH CO., LTD.               510(k) NO: K032617(TRADITIONAL)
ATTN: JEN  KE-MIN                 PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST.              SE DECISION MADE: 12-NOV-03
NSIN-CHU CITY, ROC, CHINA (TAIWAN)510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WU'S 3-WHEELED NEO SCOOTER, MODEL WT-M3JR
WU'S TECH CO., LTD.               510(k) NO: K033032(TRADITIONAL)
ATTN: KE-MIN  JEN                 PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST.              SE DECISION MADE: 10-NOV-03
HSIN-CHU CITY, CHINA (TAIWAN) ROC 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM
XITEC HOLDINGS LLC.               510(k) NO: K033066(SPECIAL)
ATTN: DANIEL J DILLON             PHONE NO : 508-643-0434
49 PLAIN STREET                   SE DECISION MADE: 12-NOV-03
NORTH ATTLEBORO, MA 02760         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Y.E.S POWERED WHEELCHAIR. T180
YEOU EIR SHUEN MACHINERY CO., LTD.510(k) NO: K032512(TRADITIONAL)
ATTN: JEN  KE-MIN                 PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST.              SE DECISION MADE: 12-NOV-03
HSIN-CHU CITY, ROC, CHINA (TAIWAN)510(k) STATEMENT

DEVICE: Y.E.S. POWERED WHEELCHAIR, MODEL T200
YEOU EIR SHUEN MACHINERY CO., LTD.510(k) NO: K032669(TRADITIONAL)
ATTN: KE-MIN  JEN                 PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST.              SE DECISION MADE: 12-NOV-03
HSIN-CHU CITY, CHINA (TAIWAN)     510(k) STATEMENT

DEVICE: BLUE SAIL (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
ZIBO BLUE SAIL PLASTIC & RUBBER PR510(k) NO: K032781(TRADITIONAL)
ATTN: CHEN  YUHONG                PHONE NO : 86 106 5666660125
RM 707, AVIC BLDG., NO. 2         SE DECISION MADE: 13-NOV-03
DONG SAN HUAN NAN ROAD            510(k) SUMMARY AVAILABLE FROM FDA
CHAOYANG DISTRICT, BEIJING, CHINA 100022

 
DEVICE: BLUE SAIL (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES
ZIBO BLUE SAIL PLASTIC & RUBBER PR510(k) NO: K032783(TRADITIONAL)
ATTN: CHEN  YUHONG                PHONE NO : 86 106 5666660125
RM 707, AVIC BLDG., NO. 2         SE DECISION MADE: 13-NOV-03
DONG SAN HUAN NAN ROAD            510(k) SUMMARY AVAILABLE FROM FDA
CHAOYANG DISTRICT, BEIJING, CHINA 100022

DEVICE: VERSYS BEADED FULLCOAT CALCAR HIP PROSTHESIS
ZIMMER, INC.                      510(k) NO: K033034(SPECIAL)
ATTN: KAREN  CAIN                 PHONE NO : 574-372-4219
P.O. BOX 708                      SE DECISION MADE: 05-NOV-03
WARSAW, IN 46581-0708             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHA
ZOLL MEDICAL CORP.                510(k) NO: K032439(ABBREVIATED)
ATTN: SCOTT  AUGUST               PHONE NO : 800-348-9011
269 MILL ROAD                     SE DECISION MADE: 05-NOV-03
CHELMSFORD, MA 01824-4105         510(k) STATEMENT

DEVICE: ZOLL AUTOCLAVABLE INTERNAL HANDLES
ZOLL MEDICAL CORP.                510(k) NO: K032691(TRADITIONAL)
ATTN: PAUL  DIAS                  PHONE NO : 978-421-9655
269 MILL ROAD                     SE DECISION MADE: 13-NOV-03
CHELMSFORD, MA 01824-4105         510(k) STATEMENT


 
                                                TOTAL 510(k)s THIS PERIOD   271
                                                TOTAL WITH SUMMARIES        236
                                                TOTAL WITH STATEMENTS        35
Updated December 8, 2003
horizonal rule
Center for Devices and Radiological Health / CDRH