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510(k)s Final Decisions Rendered for February 2001 |
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-FEB-2001 THROUGH 28-FEB-2001 DEVICE: OCO DENTAL IMPLANT "O" CO., INC. 510(k) NO: K010142(SPECIAL) ATTN: DAVID D DALISE PHONE NO : 505-293-0025 600 PAISANO, N.E., SUITE A SE DECISION MADE: 01-FEB-01 ALBUQUERQUE, NM 87123 510(k) STATEMENT DEVICE: UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450 A & A MEDICAL, INC. 510(k) NO: K010056(TRADITIONAL) ATTN: JIHAD MANSOUR PHONE NO : 770-343-8400 9370 INDUSTRIAL TRACE SE DECISION MADE: 01-FEB-01 ALPHARETTA, GA 30004-3383 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALI 3D TOOL MODULE FOR MEDICAL IMAGES A.L.I. TECHNOLOGIES, INC. 510(k) NO: K003762(TRADITIONAL) ATTN: ROBERT MACNEIL PHONE NO : 604 279 5422 130- 10711 CAMBIE ROAD SE DECISION MADE: 28-FEB-01 RICHMOND, B.C., CANADA V6X 3G5 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II A.R.C. LASER AG 510(k) NO: K003512(TRADITIONAL) ATTN: DANIEL HOEFER PHONE NO : 801-972-1311 2417 SOUTH 3850 WEST SE DECISION MADE: 08-FEB-01 SALT LAKE CITY, UT 84120 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACE SDS 3.75MM SCREW DENTAL IMPLANT ACE SURGICAL SUPPLY CO., INC. 510(k) NO: K002075(TRADITIONAL) ATTN: J. EDWARD CARCHIDI PHONE NO : 508-588-3100 1034 PEARL STREET SE DECISION MADE: 02-FEB-01 P.O. BOX 1710 510(k) STATEMENT BROCKTON, MA 02403 DEVICE: ACTHERM DIGITAL CLINICAL THERMOMETER, MODELS ACT2000, ACT2010, A ACTHERM, INC. 510(k) NO: K010238(TRADITIONAL) ATTN: RICHARD HSIEH PHONE NO : 886 355 37315 10TH F. #43 KUAN-MIN 6 ROAD SE DECISION MADE: 06-FEB-01 JUBEI, HSINCHU, CHINA (TAIWAN) 302510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: P3IMRT TM ADAC LABORATORIES 510(k) NO: K002237(TRADITIONAL) ATTN: JANICE E BROWN PHONE NO : 408-468-3766 540 ALDER DR. SE DECISION MADE: 02-FEB-01 MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY AESCULAP, INC. 510(k) NO: K003608(TRADITIONAL) ATTN: LISA M MILLINGTON PHONE NO : 800-258-1946 944 MARCON BLVD SE DECISION MADE: 20-FEB-01 ALLENTOWN, PA 18109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSPEED EC MOTORSYSTEM GD650/GD653 AESCULAP, INC. 510(k) NO: K003612(TRADITIONAL) ATTN: JOYCE THOMAS PHONE NO : 800-258-1946 3773 EXECUTIVE CENTER PARKWAY SE DECISION MADE: 20-FEB-01 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 2010 PLUS HOLTER FOR WINDOWS AGILENT TECHNOLOGIES 510(k) NO: K003940(SPECIAL) ATTN: GRETEL LUMLEY PHONE NO : 800-235-5941 1201 "B" N. RICE AVE SE DECISION MADE: 08-FEB-01 OXNARD, CA 93030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODU AGILENT TECHNOLOGIES DEUTSCHLAND G510(k) NO: K002758(TRADITIONAL) ATTN: EGON PFEIL PHONE NO : 031-464-7223 HERRENBERGER STRASSE 130 SE DECISION MADE: 22-FEB-01 D 71034 BOEBLINGEN 510(k) SUMMARY AVAILABLE FROM FDA BOEBLINGEN,, GERMANY D 71034 DEVICE: M2376A DEVICELINK SYSTEM AGILENT TECHNOLOGIES, INC. 510(k) NO: K010048(SPECIAL) ATTN: MIKE HUDON PHONE NO : 978-659-3173 3000 MINUTEMAN RD. SE DECISION MADE: 01-FEB-01 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M2376A DEVICELINK SYSTEM, MODEL M2376A AGILENT TECHNOLOGIES, INC. 510(k) NO: K010342(SPECIAL) ATTN: MIKE HUDON PHONE NO : 978-659-3173 3000 MINUTEMAN RD. SE DECISION MADE: 14-FEB-01 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERILE NITRILE POWDER-FREE EXAMINATION GLOVES ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K010211(SPECIAL) ATTN: ERICA SETHI PHONE NO : 847-473-1500 1500 WAUKEGAN RD. SE DECISION MADE: 15-FEB-01 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPLETE BRAND MULTI-PURPOSE SOLUTION ALLERGAN, INC. 510(k) NO: K003252(TRADITIONAL) ATTN: PAUL J NOWACKI PHONE NO : 714-246-6761 2525 DUPONT DR. SE DECISION MADE: 21-FEB-01 IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOJAVE CATARACT EXTRACTION SYSTEM ALLERGAN, INC. 510(k) NO: K003638(ABBREVIATED) ATTN: MARK O'DONNELL PHONE NO : 714-246-2226 2525 DUPONT DR. SE DECISION MADE: 13-FEB-01 IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT L AMERICAN BIOCURVE, INC. 510(k) NO: K001585(TRADITIONAL) ATTN: MARTIN DALSING PHONE NO : 970-243-5490 623 GLACIER DR. SE DECISION MADE: 13-FEB-01 GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOLY DRAGON ACUPUNCTURE NEEDLES ANC IMPORT & EXPORT CO. LTD. 510(k) NO: K002910(TRADITIONAL) ATTN: WILLIAM ZHANG PHONE NO : 817-572-6790 4309 MURWICK DRIVE SE DECISION MADE: 07-FEB-01 ARLINGTON, TX 76016 510(k) STATEMENT DEVICE: APPLIED BIOTECH, INC. SURESTEP ER DRUG SCREEN TEST APPLIED BIOTECH, INC. 510(k) NO: K003160(TRADITIONAL) ATTN: DAVE D SMITH PHONE NO : 858-713-9614 10237 FLANDERS CT. SE DECISION MADE: 08-FEB-01 SAN DIEGO, CA 92121 510(k) STATEMENT DEVICE: SUCTION IRRIGATOR APPLIED MEDICAL 510(k) NO: K003443(TRADITIONAL) ATTN: ANIL BHALANI PHONE NO : 949-713-8327 22872 AVENIDA EMPRESA SE DECISION MADE: 01-FEB-01 RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: X-SEPT TRANSSEPTAL SHEATH AND TRANSITION CATHETER, MODEL MV-03-0 APPRIVA MEDICAL, INC. 510(k) NO: K002054(TRADITIONAL) ATTN: MICHAEL KOLBER PHONE NO : 650-691-4595 777 NORTH PASTORIA AVENUE SE DECISION MADE: 16-FEB-01 SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AURORA AURORA IMAGING TECHNOLOGY, INC. 510(k) NO: K003651(TRADITIONAL) ATTN: JAMES J ROGERS PHONE NO : 800-858-8667 46 JONSPIN RD. SE DECISION MADE: 21-FEB-01 WILMINGTON, MA 01887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRASOUND SCANNER TYPE 2101 B-K MEDICAL A/S 510(k) NO: K003041(TRADITIONAL) ATTN: VILLY BRAENDER PHONE NO : 011 454 5970100 SANDTOFTEN 9 SE DECISION MADE: 07-FEB-01 GENTOFTE, DENMARK DK-2820 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN BANTA HEALTHCARE 510(k) NO: K003749(TRADITIONAL) ATTN: YOLNDA SMITH PHONE NO : 410-451-0639 PO BOX 4341 SE DECISION MADE: 23-FEB-01 CROFTON, MD 21114 510(k) STATEMENT DEVICE: SYNTRA DIALYZER, MODEL SYNTRA 120, 160 BAXTER HEALTHCARE CORP. 510(k) NO: K002210(TRADITIONAL) ATTN: ROBERT L WILKINSON PHONE NO : 847-473-6335 1620 WAUKEGAN RD., MPR-A2E SE DECISION MADE: 14-FEB-01 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVIA 120 HEMATOLOGY BAYER CORP. 510(k) NO: K003796(TRADITIONAL) ATTN: FREDRICK CLERIE PHONE NO : 914-524-2954 511 BENEDICT AVE. SE DECISION MADE: 05-FEB-01 TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CA BAYLIS MEDICAL CO., INC. 510(k) NO: K990284(TRADITIONAL) ATTN: KRIS SHAH PHONE NO : 905 602 4875 5160 EXPLORER DRIVE, UNIT 5 SE DECISION MADE: 01-FEB-01 MISSISSAUGA, CANADA L4W-4T7 510(k) STATEMENT DEVICE: BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE BD BECTON DICKINSON VACUTAINER SYS510(k) NO: K003461(TRADITIONAL) ATTN: M. WENDY BOSSHARDT PHONE NO : 201-847-6280 1 BECTON DR. SE DECISION MADE: 01-FEB-01 FRANKLIN LAKES, NJ 07417-1880 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190 BECKMAN COULTER, INC. 510(k) NO: K010064(SPECIAL) ATTN: STAN SUGRUE PHONE NO : 305-380-4552 11800 SW 147TH AVE. SE DECISION MADE: 07-FEB-01 MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 5C-ES CELL CONTROL, MODELS 7547191, 7547192 BECKMAN COULTER, INC. 510(k) NO: K010066(SPECIAL) ATTN: STAN SUGRUE PHONE NO : 305-380-4552 11800 SW 147TH AVE. SE DECISION MADE: 07-FEB-01 MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726 BENTEC MEDICAL, INC. 510(k) NO: K002650(TRADITIONAL) ATTN: DAVID TUCKER PHONE NO : 530-406-3333 1380 EAST BEAMER ST. SE DECISION MADE: 16-FEB-01 WOODLAND, CA 95776 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOLOK SCREW, BIOSTEON SCREW BIOCOMPOSITES LTD. 510(k) NO: K003641(TRADITIONAL) ATTN: J.STEPHEN BRATT PHONE NO : 441 782 206500 ETRUSCAN ST., ETRURIA SE DECISION MADE: 08-FEB-01 STOKE ON TRENT, UNITED KINGDOM ST1510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOLUCENT MAMMOGRAPHY CUSHION BIOLUCENT, INC. 510(k) NO: K003795(TRADITIONAL) ATTN: STEVE GEX PHONE NO : 949-349-1380 27121 ALISO CREEK ROAD SE DECISION MADE: 14-FEB-01 SUITE 125 510(k) SUMMARY AVAILABLE FROM FDA ALISO VIEJO, CA 92656 DEVICE: EZ-HCG URINE(PREGNANCY TEST) BIOMERICA, INC. 510(k) NO: K003856(TRADITIONAL) ATTN: JAY SINGH PHONE NO : 949-645-2111 1533 MONROVIA AVE. SE DECISION MADE: 21-FEB-01 NEWPORT BEACH, CA 92663 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3I CALCIUM SODIUM PHOSPHATE BONE CEMENT BIOMET, INC. 510(k) NO: K003493(TRADITIONAL) ATTN: SARA A BAILEY PHONE NO : 219-372-1568 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 09-FEB-01 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: OFFSET TIBIAL TRAY BIOMET, INC. 510(k) NO: K010212(SPECIAL) ATTN: CAROL LAUSTER PHONE NO : 219-267-6639 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 14-FEB-01 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040 BIONX IMPLANTS, INC. 510(k) NO: K003659(TRADITIONAL) ATTN: TUIJA ANNALA PHONE NO : 358 331 65600 HERMIANKATU 6-8 L SE DECISION MADE: 20-FEB-01 TAMPERE, FINLAND FIN-33720 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMOFX MESH BIONX IMPLANTS, LTD. 510(k) NO: K003757(TRADITIONAL) ATTN: TUIJA ANNALA PHONE NO : 358 331 65600 HERMIANKATU 6-8 L SE DECISION MADE: 07-FEB-01 TAMPERE, FINLAND FIN-33720 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINIQUANT D-DIMER, MODEL 1447 BIOPOOL INTL., INC. 510(k) NO: K002642(TRADITIONAL) ATTN: MICHAEL D BICK PHONE NO : 805-654-0643 6025 NICOLLE ST., SUITE D SE DECISION MADE: 05-FEB-01 VENTURA, CA 93003 510(k) STATEMENT DEVICE: MODIFICATION TO ARTOSCAN M BIOSOUND ESAOTE, INC. 510(k) NO: K010057(SPECIAL) ATTN: COLLEEN HITTLE PHONE NO : 317-849-1793 8000 CASTLEWAY DR. SE DECISION MADE: 02-FEB-01 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONSTELLATION CATHETER, MODEL 8031 BOSTON SCIENTIFIC CORP. 510(k) NO: K003782(SPECIAL) ATTN: ANDREA BOUMIS PHONE NO : 408-895-3625 2710 ORCHARD PARKWAY SE DECISION MADE: 14-FEB-01 SAN JOSE, CA 95134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Z-TOUCH BRAINLAB, AG 510(k) NO: K003268(TRADITIONAL) ATTN: PHONE NO : 100 MARINE PARKWAY SE DECISION MADE: 22-FEB-01 SUITE 305 510(k) SUMMARY AVAILABLE FROM FDA REDWOOD CITY, CA 94065 DEVICE: BMR DENTAL IMPLANT SYSTEM, MODEL 3.3XX, EITHER HA OR TPS COATED, BUCK MEDICAL RESEARCH 510(k) NO: K010343(TRADITIONAL) ATTN: REBECCA ELLIS PHONE NO : 214-522-5780 2811 LEMMON AVE., SUITE 201 SE DECISION MADE: 14-FEB-01 DALLAS, TX 75204 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER C.R. BARD, INC. 510(k) NO: K010169(SPECIAL) ATTN: CAROL VIERLING PHONE NO : 770-385-2347 13183 HARLAND DRIVE SE DECISION MADE: 13-FEB-01 COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVANTAGE SINGLE-USE ELECTROSURGICAL ATTACHMENT-J-HOOK TIP, L-HO C.R. BARD, INC. 510(k) NO: K010444(TRADITIONAL) ATTN: KERRY CHUNKO PHONE NO : 785-843-7782 700 EAST 22ND ST SE DECISION MADE: 28-FEB-01 LAWRENCE, KS 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CARDIOMEDICS ECP SYSTEM CARDIOMEDICS, INC. 510(k) NO: K010261(SPECIAL) ATTN: JOHN HUTCHINS PHONE NO : 949-863-2500 18872 BARDEEN AVE. SE DECISION MADE: 28-FEB-01 IRVINE, CA 92612 510(k) STATEMENT DEVICE: VISULAS YAG II CARL ZEISS, INC. 510(k) NO: K003885(TRADITIONAL) ATTN: SCOTT A MARGOLIN PHONE NO : 914-681-7880 ONE ZEISS DR. SE DECISION MADE: 22-FEB-01 THORNWOOD, NY 10594 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUAL LUMEN MIDLINE CATHETER CATHETER INNOVATIONS, INC. 510(k) NO: K010349(SPECIAL) ATTN: ROGER L RICHINS PHONE NO : 801-954-8444 3598 WEST 1820 SOUTH SE DECISION MADE: 28-FEB-01 SALT LAKE CITY, UT 84104-4859 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES CIBA-GEIGY CORP. 510(k) NO: K003586(TRADITIONAL) ATTN: STEVEN DOWDLEY PHONE NO : 678-415-3897 11460 JOHNS CREEK PKWY. SE DECISION MADE: 08-FEB-01 DULUTH, GA 30136-1518 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE COALESCENT SURGICAL 510(k) NO: K003958(TRADITIONAL) ATTN: MICHAEL A DANIEL PHONE NO : 415-407-0223 559 EAST WEDDELL DR. SE DECISION MADE: 06-FEB-01 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS CODMAN & SHURTLEFF, INC. 510(k) NO: K003549(TRADITIONAL) ATTN: JAMES M FLAHERTY PHONE NO : 508-880-8404 325 PARAMOUNT DR. SE DECISION MADE: 15-FEB-01 RAYNHAM, MA 02767-0350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TAPER-FIT TOTAL HIP SYSTEM CORIN U.S.A. 510(k) NO: K003666(TRADITIONAL) ATTN: JOEL K BATTS PHONE NO : 813-977-4469 10500 UNIVERSITY CENTER DR., SE DECISION MADE: 08-FEB-01 SUITE 190 510(k) SUMMARY AVAILABLE FROM FDA TAMPA, FL 33612 DEVICE: TRI-FIT FEMORAL STEM CORIN U.S.A. 510(k) NO: K010243(SPECIAL) ATTN: JOEL K BATTS PHONE NO : 813-977-4469 10500 UNIVERSITY CENTER DR., SE DECISION MADE: 15-FEB-01 SUITE 190 510(k) SUMMARY AVAILABLE FROM FDA TAMPA, FL 33612 DEVICE: SERENOCEM, MODEL BC 010 CORINTHIAN MEDICAL LTD. 510(k) NO: K003567(TRADITIONAL) ATTN: DAGMAR MASER PHONE NO : 312 042 89591 AMSTEL 320-1 SE DECISION MADE: 12-FEB-01 AMERSTDAM, NETHERLANDS 1017 AP 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORTEX METAMAX CORTEX BIOPHYSIK GMBH 510(k) NO: K001631(TRADITIONAL) ATTN: ART WARD PHONE NO : 813-645-2855 962 ALLEGRO LANE SE DECISION MADE: 22-FEB-01 APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONTROL MODULE ALGORITHM ENHANCEMENT FOR THE MODEL S500-ST AND M CURON MEDICAL, INC. 510(k) NO: K010210(SPECIAL) ATTN: THOMAS C WEHMAN PHONE NO : 408-733-9910 735 PALOMAR ST. SE DECISION MADE: 21-FEB-01 SUNNYVALE, CA 94086 510(k) STATEMENT DEVICE: RCRP FLEX REAGENT CARTRIDGE DADE BEHRING, INC. 510(k) NO: K003419(TRADITIONAL) ATTN: LORRAINE H PIETRAK PHONE NO : 302-631-6279 GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 14-FEB-01 BLDG. 500 MAIL BOX 514 510(k) SUMMARY AVAILABLE FROM FDA P.O. BOX 6101, NEWARK, DE 19714-6101 DEVICE: THROMBOREL S DADE BEHRING, INC. 510(k) NO: K003870(TRADITIONAL) ATTN: REBECCA S AYASH PHONE NO : 302-631-6276 P.O. BOX 6101 SE DECISION MADE: 20-FEB-01 NEWARK,, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION PSA FLEX REAGENT CARTRIDGE DADE BEHRING, INC. 510(k) NO: K003963(TRADITIONAL) ATTN: GEORGE M PLUMMER PHONE NO : 302-631-9798 GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 28-FEB-01 BLDG. 500 P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137 DADE BEHRING, INC. 510(k) NO: K010208(TRADITIONAL) ATTN: RICHARD M VAUGHT PHONE NO : 302-631-6567 GLASCO B500 M.S. 514 SE DECISION MADE: 20-FEB-01 P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: AML HIP PROSTHESIS DEPUY ORTHOPAEDICS, INC. 510(k) NO: K003800(TRADITIONAL) ATTN: MARCIA J ARENTZ PHONE NO : 219-371-4944 700 ORTHOPAEDIC DR. SE DECISION MADE: 09-FEB-01 P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: ELECTRICATOR MODEL 26000 DERMATOLOGIC LAB & SUPPLY, INC. 510(k) NO: K010025(TRADITIONAL) ATTN: DEBORAH GRAFELMAN PHONE NO : 712-323-3269 608 13TH AVE. SE DECISION MADE: 22-FEB-01 COUNCIL BLUFFS, IA 51501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE M DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K003597(TRADITIONAL) ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200 5700 WEST 96TH ST. SE DECISION MADE: 05-FEB-01 LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMU DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K004002(TRADITIONAL) ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200 5700 WEST 96TH ST. SE DECISION MADE: 14-FEB-01 LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASSERACHROM HPIA TEST KIT DIAGNOSTICA STAGO, INC. 510(k) NO: K003767(TRADITIONAL) ATTN: ANDREW LOC B LE PHONE NO : 973-631-1200 FIVE CENTURY DR. SE DECISION MADE: 12-FEB-01 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASE-A-CULT DIAGNOSTICA, INC. 510(k) NO: K002756(TRADITIONAL) ATTN: YOLANDA SMITH PHONE NO : 410-451-0639 P.O. BOX 4341 SE DECISION MADE: 23-FEB-01 CROFTON, MD 21114 510(k) STATEMENT DEVICE: DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID DISETRONIC MEDICAL SYSTEMS AG 510(k) NO: K003977(TRADITIONAL) ATTN: DAVID E CHADWICK PHONE NO : 763-795-5277 5151 PROGRAM AVENUE SE DECISION MADE: 15-FEB-01 ST. PAUL, MN 55112-1014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICTEC ENDOSCOPES AND ACCESSORIES DUFNER INSTRUMENTE GMBH 510(k) NO: K002877(ABBREVIATED) ATTN: DAGMAR MASER PHONE NO : 312 042 89591 AMSTEL 320-I SE DECISION MADE: 05-FEB-01 AMSTERDAM, NETHERLANDS 1017AP 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUO-DENT DENTAL IMPLANT DUO-DENT DENTAL IMPLANT SYSTEMS LL510(k) NO: K010386(SPECIAL) ATTN: MICHAEL H VOVOLKA PHONE NO : 847-856-0355 P.O. BOX 848 SE DECISION MADE: 27-FEB-01 GRAYSLAKE, IL 60030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBI VUECATH SPINAL ENDOSCOPIC SYSTEM EBI, L.P. 510(k) NO: K010179(SPECIAL) ATTN: JON CAPAROTTA PHONE NO : 973-299-9022 100 INTERPACE PKWY. SE DECISION MADE: 09-FEB-01 PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS EDAP TECHNOMED, INC. 510(k) NO: K003529(ABBREVIATED) ATTN: SCOTT J MINDREBO PHONE NO : 770-446-9950 100 PINNACLE WAY, SUITE 100 SE DECISION MADE: 12-FEB-01 NORCROSS, GA 30071 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS ENVIRONMENTAL TEST SYSTEMS, INC. 510(k) NO: K003615(SPECIAL) ATTN: BRUCE G PIEKARSKI PHONE NO : 219-262-2060 P.O. BOX 4659 SE DECISION MADE: 01-FEB-01 ELKHART, IN 46514 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FREEDLAND TENSION SYSTEM ETZEM TECHNOLOGIES, INC. 510(k) NO: K003648(TRADITIONAL) ATTN: AHAVA SHEIN PHONE NO : 972 976 70002 20 HATA'AS ST. SE DECISION MADE: 23-FEB-01 BEIT HAPA'AMON BOX 124 510(k) STATEMENT KFAR SABA, ISRAEL 44425 DEVICE: CEMEX SYSTEM GUN APPLICATION VERSION EXACTECH, INC. 510(k) NO: K000943(TRADITIONAL) ATTN: GARY J MILLER PHONE NO : 352-377-1140 2320 N.W. 66TH COURT SE DECISION MADE: 08-FEB-01 GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS EXACTECH, INC. 510(k) NO: K010081(SPECIAL) ATTN: LISA SIMPSON PHONE NO : 352-377-1140 2320 N.W. 66TH CT. SE DECISION MADE: 05-FEB-01 GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIE EXACTECH, INC. 510(k) NO: K010120(SPECIAL) ATTN: GARY J MILLER PHONE NO : 352-377-1140 2320 N.W. 66TH CT. SE DECISION MADE: 09-FEB-01 GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EEG WITH VIDEO, MODEL EX-NW EXCEL TECH. LTD. 510(k) NO: K010091(SPECIAL) ATTN: SONJA MARKEZ PHONE NO : 905 829 5300 2568 BRISTOL CIRCLE SE DECISION MADE: 01-FEB-01 OAKVILLE, ONTARIO, CANADA L6H 5S1510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 64 CHANNEL EEG / MODEL NUMBER EX-NW-64 EXCEL TECH. LTD. 510(k) NO: K010150(SPECIAL) ATTN: SONJA MARKEZ PHONE NO : 2568 BRISTOL CIRCLE SE DECISION MADE: 09-FEB-01 OAKVILLE, ONTARIO, CANADA L6H 5S1510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET EXELINT INTERNATIONAL COMPANY 510(k) NO: K003627(TRADITIONAL) ATTN: ARMAND HAMID PHONE NO : 310-649-0707 5840 W. CENTINELA AVENUE SE DECISION MADE: 08-FEB-01 LOS ANGELES, CA 90231-3194 510(k) STATEMENT DEVICE: EYETECT TREMOR MONITOR UNIT (TMU) EYETECT, L.L.C. 510(k) NO: K003644(TRADITIONAL) ATTN: REBECCA M CUETO PHONE NO : 618-235-8609 10 MADONNA COURT SE DECISION MADE: 01-FEB-01 BELLEVILLE,, IL 62223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FADASSI MEDICAL FM-1 NO BLENDER FADASIS MEDICAL, INC. 510(k) NO: K003665(TRADITIONAL) ATTN: RAYMOND RIDDLE PHONE NO : 608-831-0025 7601-B MURPHY DRIVE SE DECISION MADE: 23-FEB-01 MIDDLETOWN, WI 53562 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: (DISPOSABLE) VAGINAL SPECULUM FEMINICA INC. 510(k) NO: K003540(TRADITIONAL) ATTN: DENIS H DUBOIS PHONE NO : 514 875 4422 3216 MONSABRE SE DECISION MADE: 09-FEB-01 MONTREAL, QUEBEC, CANADA H1N 2L5 510(k) STATEMENT DEVICE: MICROTARGETING DRIVE SYSTEM FHC, INC. 510(k) NO: K003776(TRADITIONAL) ATTN: FREDERICK HAER PHONE NO : 207-666-8190 9 MAIN STREET SE DECISION MADE: 23-FEB-01 BOWDOINHAM, ME 04008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL GE MEDICAL SYSTEMS 510(k) NO: K003946(TRADITIONAL) ATTN: LARRY A KROGER PHONE NO : 414-544-3894 P.O. BOX 414, W-709 SE DECISION MADE: 27-FEB-01 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVANTAGE WINDOWS CT/PET FUSION GE MEDICAL SYSTEMS, INC. 510(k) NO: K010336(TRADITIONAL) ATTN: LARRY A KROGER PHONE NO : 262-544-3894 P.O. BOX 414 SE DECISION MADE: 16-FEB-01 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09 GEBAUER CO. 510(k) NO: K002596(TRADITIONAL) ATTN: DENISE E SPELLMAN PHONE NO : 216-271-0910 9410 ST. CATHERINE AVE. SE DECISION MADE: 15-FEB-01 CLEVELAND, OH 44104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: URETEROSCOPES GLOBAL ENDOSCOPY, INC. 510(k) NO: K003806(TRADITIONAL) ATTN: NICK MIRCEA PHONE NO : 847-301-2733 914 W. ESTES CT. SE DECISION MADE: 22-FEB-01 SCHAUMBURG, IL 60193-4426 510(k) STATEMENT DEVICE: CYSTOSCOPES GLOBAL ENDOSCOPY, INC. 510(k) NO: K003807(TRADITIONAL) ATTN: NICK MIRCEA PHONE NO : 847-301-2733 914 W. ESTES CT. SE DECISION MADE: 22-FEB-01 SCHAUMBURG, IL 60193-4426 510(k) STATEMENT DEVICE: ANCURE LLIAC BALLOON CATHETER GUIDANT CARDIAC AND VASCULAR SURGE510(k) NO: K003495(TRADITIONAL) ATTN: JACQUELINE J JACKSON PHONE NO : 650-470-6200 1525 O'BRIEN DR. SE DECISION MADE: 07-FEB-01 MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITRILE EXAMINATION GLOVES (POWERED) GUTHRIE MEDICARE PRODUCTS (NS) SDN510(k) NO: K003922(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 15-FEB-01 GREAT NECK, NY 11021 510(k) STATEMENT DEVICE: POWDERFREE NITRILE PATIENT EXMINATION GLOVE GUTHRIE MEDICARE PRODUCTS (NS) SDN510(k) NO: K003985(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 09-FEB-01 GREAT NECK, NY 11021 510(k) STATEMENT DEVICE: MAC ACUPUNCTURE NEEDLE HAENGLIM SEOWON CORP. 510(k) NO: K002827(TRADITIONAL) ATTN: YUN CHOL CHO PHONE NO : 718-886-4469 34-69 LEAVITT ST. SE DECISION MADE: 28-FEB-01 FLUSHING, NY 11354 510(k) STATEMENT DEVICE: TRITON HIP SYSTEM HAYES MEDICAL, INC. 510(k) NO: K003649(TRADITIONAL) ATTN: WILLIAM J GRIFFIN PHONE NO : 916-355-7156 1115 WINDFIELD WAY, SUITE 100 SE DECISION MADE: 23-FEB-01 EL DORADO HILLS, CA 95762-9623 510(k) STATEMENT DEVICE: MEDRELIEF HEALTHONICS, INC. 510(k) NO: K003507(TRADITIONAL) ATTN: T. WHIT ATHEY PHONE NO : 301-770-9590 12300 TWINBROOK PARKWAY SE DECISION MADE: 21-FEB-01 SUITE 625 510(k) SUMMARY AVAILABLE FROM FDA ROCKVILLE, MD 20852 DEVICE: ACCUFUSER; ACCUFUSER PLUS HELPTECHNOLOGIES 510(k) NO: K003915(TRADITIONAL) ATTN: ROBERT J BARD PHONE NO : 949-240-1290 24312 ARMADA DR. SE DECISION MADE: 15-FEB-01 DANA POINT, CA 92629 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXTIME MAGNUM 360 HERAEUS KULZER, INC. 510(k) NO: K003930(TRADITIONAL) ATTN: CHERYL ZIMMERMAN PHONE NO : 219-299-6662 4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 01-FEB-01 SOUTH BEND, IN 46614-2517 510(k) STATEMENT DEVICE: MODULAR HEYER AMERICA, INC. 510(k) NO: K001988(TRADITIONAL) ATTN: ART WARD PHONE NO : 813-645-2855 962 ALLEGRO LANE SE DECISION MADE: 05-FEB-01 APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VORTEX ACCESS SYSTEM HORIZON MEDICAL PRODUCTS, INC. 510(k) NO: K010189(SPECIAL) ATTN: PENNY M NORTHCUTT PHONE NO : 706-846-3126 1 HORIZON WAY SE DECISION MADE: 12-FEB-01 MANCHESTER, GA 31816 510(k) STATEMENT DEVICE: TEKNIQUE HOVEROUND CORP. 510(k) NO: K010075(SPECIAL) ATTN: TONY DIGIOVANNI PHONE NO : 941-739-6200 2151 WHITFIELD INDUSTRIAL WAY SE DECISION MADE: 14-FEB-01 SARASOTA, FL 34243 510(k) STATEMENT DEVICE: ENHANCED POLYETHYLENE KNEE PROSTHESES HOWMEDICA OSTEONICS CORP. 510(k) NO: K001147(TRADITIONAL) ATTN: MARY-CATHERINE DILLON PHONE NO : 201-760-8117 59 ROUTE 17 SE DECISION MADE: 15-FEB-01 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES I.C. MEDICAL, INC. 510(k) NO: K003840(TRADITIONAL) ATTN: CRAIG HARSHMAN PHONE NO : 623-780-0700 2002 WEST QUAIL AVE SE DECISION MADE: 01-FEB-01 PHOENIX, AZ 85027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECIALTY 55 & MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC CONT IGEL VISIONCARE PTE LTD. 510(k) NO: K003833(TRADITIONAL) ATTN: JOHN M SZABOCSIK PHONE NO : 312-553-0828 203 NORTH WABASH AVENUE SE DECISION MADE: 13-FEB-01 SUITE 1200 510(k) SUMMARY AVAILABLE FROM FDA CHICAGO, IL 60601 DEVICE: INTRAVASCULAR ADMINISTRATION SET INFUSION DEVICES, INC. 510(k) NO: K003854(TRADITIONAL) ATTN: PAUL E DRYDEN PHONE NO : 317-335-3780 6329 W. WATERVIEW CT. SE DECISION MADE: 05-FEB-01 MCCORDSVILLE, IN 46055 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIO-EYE II ORBITAL IMPLANT INTEGRATED ORBITAL IMPLANTS, INC. 510(k) NO: K003338(TRADITIONAL) ATTN: FLOYD G LARSON PHONE NO : 858-792-1235 4329 GRAYDON ROAD SE DECISION MADE: 07-FEB-01 SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHALLENGER DIRECT COMPOSITE INTERNATIONAL DENTAL RESEARCH 510(k) NO: K010219(SPECIAL) ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552 5 WHITCOMB AVE. SE DECISION MADE: 21-FEB-01 AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOTAL BILIRUBIN REAGENT INTERSECT SYSTEMS, INC. 510(k) NO: K003892(TRADITIONAL) ATTN: JOAN CATHEY PHONE NO : 360-577-1062 P.O. BOX 2219 SE DECISION MADE: 20-FEB-01 LONGVIEW, WA 98632 510(k) STATEMENT DEVICE: MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LY INVACARE CORP. 510(k) NO: K010135(TRADITIONAL) ATTN: RAE A FARROW PHONE NO : 440-329-6356 ONE INVACARE WAY SE DECISION MADE: 16-FEB-01 ELYRIA, OH 44036 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUTUREGROOVE WEIGHT SIZING SET IOP, INC. 510(k) NO: K003646(TRADITIONAL) ATTN: JASON MALECKA PHONE NO : 714-549-1185 3151 AIRWAY AVE., BLDG. I-1 SE DECISION MADE: 22-FEB-01 COSTA MESA, CA 92626 510(k) STATEMENT DEVICE: MXR-2000 MOBILE X-RAY UNIT IROM IMAGING, INC. 510(k) NO: K010304(TRADITIONAL) ATTN: ROMAN KRYSTYNIAK PHONE NO : 303-762-1950 3720 SOUTH LIPAN ST. SE DECISION MADE: 12-FEB-01 ENGLEWOOD, CO 80110 510(k) STATEMENT DEVICE: NUCAMMA BI90 IS2 RESEARCH INC. 510(k) NO: K003882(TRADITIONAL) ATTN: VICTOR WOODBURN PHONE NO : 613 228 8755 20 GURDWARA RD., BAYS 3-6 SE DECISION MADE: 21-FEB-01 NEPEAN, ONTARIO, CANADA K2E 8B3 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE ITAMAR MEDICAL (C.M.) 1997 LTD. 510(k) NO: K001852(TRADITIONAL) ATTN: AHAVA STEIN PHONE NO : 972 979 20673 P.O.B. 454 SE DECISION MADE: 21-FEB-01 GINOT SHOMRON 44853, ISRAEL 44853 510(k) STATEMENT DEVICE: EXCITE DSC IVOCLAR NORTH AMERICA, INC. 510(k) NO: K003293(TRADITIONAL) ATTN: ANDY GULATI PHONE NO : 716-691-0010 175 PINEVIEW DR. SE DECISION MADE: 06-FEB-01 AMHERST, NY 14228 510(k) STATEMENT DEVICE: TETRIC CERAM HB IVOCLAR NORTH AMERICA, INC. 510(k) NO: K010250(TRADITIONAL) ATTN: ANDY GULATI PHONE NO : 716-691-0010 175 PINEVIEW DR. SE DECISION MADE: 28-FEB-01 AMHERST, NY 14228 510(k) STATEMENT DEVICE: TOTAL BILIRUBIN JAS DIAGNOSTIC, INC. 510(k) NO: K003829(TRADITIONAL) ATTN: DAVID JOHNSTON PHONE NO : 305-418-2320 7220 NW 58TH ST. SE DECISION MADE: 12-FEB-01 MIAMI, FL 33166 510(k) STATEMENT DEVICE: PHOSPHORUS REAGENT JAS DIAGNOSTIC, INC. 510(k) NO: K003912(TRADITIONAL) ATTN: DAVID JOHNSTON PHONE NO : 305-418-2320 7220 NW 58TH ST. SE DECISION MADE: 21-FEB-01 MIAMI, FL 33166 510(k) STATEMENT DEVICE: COSMIC JENERIC/PENTRON, INC. 510(k) NO: K010044(TRADITIONAL) ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397 53 NO.PLAINES INDUSTRIAL ROAD SE DECISION MADE: 09-FEB-01 WALLINGFORD, CT 06492-0724 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JK GLOVES PRE-POWDERED LATEX EXAMINATION GLOVE JK GLOVES SDN. BHD. 510(k) NO: K010231(TRADITIONAL) ATTN: TAI SAI LEONG PHONE NO : 607 598 2568 LOT 26738 & 26740-K8 & P2 SE DECISION MADE: 09-FEB-01 JALAN TEE TECK SA 510(k) STATEMENT SENAI, JOHOR, MALAYSIA 81400 DEVICE: X-RAY SYSTEM XR-MX KARL STORZ ENDOSCOPY 510(k) NO: K004037(TRADITIONAL) ATTN: JENNIFER S PORTUGAL PHONE NO : 800-421-0837 600 CORPORATE POINTE SE DECISION MADE: 02-FEB-01 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODULITH LITHOTRIPSY, MODEL SLX FOR THE FRAGMENTATION OF URINARY KARL STORZ LITHOTRIPSY-AMERICA, IN510(k) NO: K010340(TRADITIONAL) ATTN: MARIKA ANDERSON PHONE NO : 310-338-8100 600 CORPORATE POINTE SE DECISION MADE: 13-FEB-01 CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOPILOT KINAMED, INC. 510(k) NO: K003347(TRADITIONAL) ATTN: JOEL SLOMOFF PHONE NO : 301-983-1707 9229 CRANFORD DRIVE SE DECISION MADE: 23-FEB-01 POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATAB KYPHON INC. 510(k) NO: K010246(TRADITIONAL) ATTN: KAREN TALMADGE PHONE NO : 408-548-6500 1350 BORDEAUX DRIVE SE DECISION MADE: 14-FEB-01 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TAI-CHI ACUPUNCTURE NEEDLES LHASA MEDICAL, INC. 510(k) NO: K003760(TRADITIONAL) ATTN: KYUNG P RIIHIMAKI PHONE NO : 781-340-1070 234 LIBBEY PARKWAY SE DECISION MADE: 06-FEB-01 WEYMOUTH, MA 02189 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET LIFEMED OF CALIFORNIA 510(k) NO: K001329(TRADITIONAL) ATTN: PATRICIA BRINKER PHONE NO : 310-638-6167 1216 S. ALLEC ST. SE DECISION MADE: 14-FEB-01 ANAHEIM, CA 92805 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERSONAL GLUCOSE CONTROL CHARTING SYSTEM LXN CORP. 510(k) NO: K002688(TRADITIONAL) ATTN: SANDRA F SELVAGGI PHONE NO : 858-320-4434 6325 LUSK BLVD. SE DECISION MADE: 01-FEB-01 SAN DIEGO, CA 92121 510(k) STATEMENT DEVICE: MAEDA NEW NEEDLE DISPOSABLE MAEDA TOYOKICHI SHOTEN 510(k) NO: K000581(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 410-451-0639 P.O. BOX 4341 SE DECISION MADE: 23-FEB-01 CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ODYSSEY LX, MODEL 211320 MARCONI MEDICAL SYSTEMS 510(k) NO: K003437(TRADITIONAL) ATTN: RONALD J MARTONE PHONE NO : 440-483-7651 595 MINER RD. SE DECISION MADE: 02-FEB-01 HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100 MARCONI MEDICAL SYSTEMS 510(k) NO: K003853(TRADITIONAL) ATTN: DUANE PRASCHAN PHONE NO : 440-483-5743 595 MINER RD. SE DECISION MADE: 13-FEB-01 HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DURABOND NON-PRECIOUS CERAMIC ALLOY MATECH, INC. 510(k) NO: K010069(TRADITIONAL) ATTN: PAUL L SAXTON PHONE NO : 818-367-2472 13000 SAN FERNANDO RD. SE DECISION MADE: 15-FEB-01 SYLMAR, CA 91342 510(k) STATEMENT DEVICE: SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE) MAXXIM MEDICAL 510(k) NO: K010297(SPECIAL) ATTN: WUNAN HUANG PHONE NO : 864-369-7391 308 CHURCH ST. SE DECISION MADE: 16-FEB-01 HONEA PATH, SC 29654 510(k) STATEMENT DEVICE: MEDLOGICS ML 4000, MODEL 4000 MED-LOGICS, INC. 510(k) NO: K002515(TRADITIONAL) ATTN: GARY MOCNIK PHONE NO : 949-363-2953 30001 GOLDEN LANTERN #334 SE DECISION MADE: 22-FEB-01 LAGUNA NIGUEL, CA 92677 510(k) STATEMENT DEVICE: MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE MEDGE PLATFORMS, INC 510(k) NO: K003672(TRADITIONAL) ATTN: GUSTAVO EDUARDO ABELLA PHONE NO : 212-808-4848 90 PARK AVENUE SE DECISION MADE: 22-FEB-01 17TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA NEW YORK, NY 10016-1301 DEVICE: DIAMOND ALOE VERA, STERILE MEDI-TECH INTL. CORP. 510(k) NO: K002666(TRADITIONAL) ATTN: HERBERT A PERRY PHONE NO : 718-875-4535 26 COURT ST. SE DECISION MADE: 27-FEB-01 BROOKLYN, NY 11242 510(k) STATEMENT DEVICE: EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER MEDICA CORP. 510(k) NO: K002407(TRADITIONAL) ATTN: PHOTIOS MAKRIS PHONE NO : 781-275-4892 14 DEANGELO DR. SE DECISION MADE: 02-FEB-01 BEDFORD, MA 01730 510(k) STATEMENT DEVICE: CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K010111(TRADITIONAL) ATTN: DARWIN RICHARDSON PHONE NO : 800-582-3095 5300 ADOLFO RD. SE DECISION MADE: 28-FEB-01 CAMARILLO, CA 93012 510(k) STATEMENT DEVICE: MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S MEDICAL COMPONENTS, INC. 510(k) NO: K010021(TRADITIONAL) ATTN: FLORENCE A CAIKOSKI PHONE NO : 215-256-4201 1499 DELP DR. SE DECISION MADE: 23-FEB-01 HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARIETEX COMPOSITE (PCO) MESH MEDICAL DEVICE CONSULTANTS, INC. 510(k) NO: K002699(TRADITIONAL) ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 15-FEB-01 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602 MEDICAL DEVICES, INC. 510(k) NO: K002280(TRADITIONAL) ATTN: WARREN R WALTERS PHONE NO : 515-244-1212 2500 BELL AVENUE SE DECISION MADE: 05-FEB-01 DES MOINES, IA 50321 510(k) STATEMENT DEVICE: NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGE MEDICAL ILLUMINATION INTERNATIONAL510(k) NO: K003489(TRADITIONAL) ATTN: DAVID GLOVER PHONE NO : 818-899-2888 547 LIBRARY ST. SE DECISION MADE: 02-FEB-01 SAN FERNANDO, CA 91340 510(k) STATEMENT DEVICE: KIMAX, MODEL 1024 MEDICAL METRICS, INC. 510(k) NO: K010187(ABBREVIATED) ATTN: ANN TUNSTALL PHONE NO : 301-652-6110 4600 NORTH PARK AVE. SE DECISION MADE: 14-FEB-01 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA CHEVY CHASE, MD 20815-4518 DEVICE: MULTI-FUNCTION DEFIBRILLATION ELECTRODE MEDICOTEST A/S 510(k) NO: K002079(TRADITIONAL) ATTN: EMALEE G MURPHY PHONE NO : 202-496-7255 1900 K STREET N.W. SE DECISION MADE: 22-FEB-01 WASHINGTON, DC 20006-1108 510(k) STATEMENT DEVICE: MEDIVISION IGS SYSTEM MEDISONIC U.S.A., INC. 510(k) NO: K003699(TRADITIONAL) ATTN: SANDRA WILLIAMSON PHONE NO : 610-647-9700 1301 GOSHEN PARKWAY SE DECISION MADE: 27-FEB-01 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDITHERM MED2000 MEDITHERM INC. 510(k) NO: K003332(TRADITIONAL) ATTN: PETER LEANDO PHONE NO : 954-575-1076 7407 DOVER LANE SE DECISION MADE: 21-FEB-01 PARKLAND, FL 33067 510(k) STATEMENT DEVICE: MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPES MEDLINE INDUSTRIES, INC. 510(k) NO: K003755(TRADITIONAL) ATTN: LARA N SIMMONS PHONE NO : 847-949-2639 ONE MEDLINE PL. SE DECISION MADE: 16-FEB-01 MUNDELEIN, IL 60060-4486 510(k) STATEMENT DEVICE: PROFILE II ER MEDTOX DIAGNOSTICS, INC. 510(k) NO: K010138(SPECIAL) ATTN: MICHAEL TURANCHIK PHONE NO : 336-226-6311 1238 ANTHONY RD. SE DECISION MADE: 14-FEB-01 BURLINGTON, NC 27215 510(k) STATEMENT DEVICE: MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP MEDTRONIC CARDIAC SURGICAL PRODUCT510(k) NO: K000776(TRADITIONAL) ATTN: JAMES BALUN PHONE NO : 616-643-5283 620 WATSON S.W. SE DECISION MADE: 07-FEB-01 GRAND RAPIDS, MI 49504 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043 MEDTRONIC FUNCTIONAL DIAGNOSTICS A510(k) NO: K010130(SPECIAL) ATTN: TOVE KJAER PHONE NO : 454 457 9000 16-18 TONSBAKKEN SE DECISION MADE: 07-FEB-01 SKOVLUNDE, DENMARK DK-2740 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES MEDTRONIC PS MEDICAL 510(k) NO: K003914(ABBREVIATED) ATTN: JANET MCAULEY PHONE NO : 805-968-1546 125 CREMONA DR. SE DECISION MADE: 22-FEB-01 GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TITANIUM CEMENT RESTRICTOR (TCR) MEDTRONIC SOFAMOR DANEK 510(k) NO: K003718(TRADITIONAL) ATTN: RICHARD W TREHARNE PHONE NO : 901-344-0807 1800 PYRAMID PLACE SE DECISION MADE: 14-FEB-01 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K010249(SPECIAL) ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 23-FEB-01 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STYLET KIT, MODELS 6254,6282,6293 MEDTRONIC, INC. 510(k) NO: K003535(TRADITIONAL) ATTN: KAREN CLEMENT PHONE NO : 763-514-9933 4000 LEXINGTON AVE., NORTH SE DECISION MADE: 08-FEB-01 SHOREVIEW, MN 55126-2893 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVEAL PLUS INSERTABLE LOOP RECORDER MEDTRONIC, INC. 510(k) NO: K003667(TRADITIONAL) ATTN: STACEY P WESSMAN PHONE NO : 763-514-9840 7000 CENTRAL AVENUE N.E. SE DECISION MADE: 14-FEB-01 MINNEAPOLIS, MN 55432-3576 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460 METRON MEDICAL AUSTRALIA P/L 510(k) NO: K003260(SPECIAL) ATTN: ROB HOPKINS PHONE NO : 039 775 1234 57 ASTER AVE. SE DECISION MADE: 22-FEB-01 CARRUM DOWNS, VICTORIA, AUSTRALIA 510(k) STATEMENT DEVICE: SONIC MODEL SO-300 METRON MEDICAL AUSTRALIA P/L 510(k) NO: K010102(SPECIAL) ATTN: ROB HOPKINS PHONE NO : 613 977 51234 57 ASTER AVE. SE DECISION MADE: 09-FEB-01 CARRUM DOWNS, VICTORIA, AUSTRALIA 510(k) STATEMENT DEVICE: FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065 MICRO THERAPEUTICS, INC. 510(k) NO: K010004(SPECIAL) ATTN: EBEN GORDEN PHONE NO : 949-837-3700 2 GOODYEAR SE DECISION MADE: 13-FEB-01 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 MICRO-MEDICAL DEVICES, INC. 510(k) NO: K003695(TRADITIONAL) ATTN: GEORGE COLEMAN PHONE NO : 216-229-8332 11000 CEDAR AVENUE SE DECISION MADE: 14-FEB-01 SUITE 445 510(k) SUMMARY AVAILABLE FROM FDA CLEVELAND, OH 44106 DEVICE: MITEK 2GII MENISCAL REPAIR SYSTEM MITEK PRODUCTS 510(k) NO: K002406(TRADITIONAL) ATTN: CAROL CHAOUI PHONE NO : 781-251-2700 249 VANDERBILT AVE. SE DECISION MADE: 15-FEB-01 NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHS-63 PEDIATRIC HEAD AND SPINE ARRAY COIL MRI DEVICES CORP. 510(k) NO: K003655(TRADITIONAL) ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402 1515 PARAMOUNT DRIVE SE DECISION MADE: 02-FEB-01 WAUKESHA, WI 53186 510(k) STATEMENT DEVICE: HRH-127 HEAD ARRAY COIL MRI DEVICES CORP. 510(k) NO: K010140(TRADITIONAL) ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402 1515 PARAMOUNT DRIVE SE DECISION MADE: 22-FEB-01 WAUKESHA, WI 53186 510(k) STATEMENT DEVICE: CURRY MULTIMODAL NEUROIMAGING SOFTWARE NEUROSOFT, INC. 510(k) NO: K001781(TRADITIONAL) ATTN: DAVID B JONES PHONE NO : 915-845-5600 5700 CROMO DRIVE SE DECISION MADE: 05-FEB-01 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA EL PASO, TX 79912 DEVICE: TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 NEW ENGLAND MEDICAL CORP. 510(k) NO: K002042(TRADITIONAL) ATTN: STEVEN FODOR PHONE NO : 845-778-4200 2274 ALBANY POST RD. SE DECISION MADE: 01-FEB-01 WALDEN, NY 12586 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORG-9200A NIHON KOHDEN AMERICA, INC. 510(k) NO: K002068(TRADITIONAL) ATTN: BONNIE BISHOP PHONE NO : 949-580-1555 90 ICON STREET SE DECISION MADE: 08-FEB-01 FOOTHILL RANCH, CA 92610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS NORTH AMERICAN MEDICAL PRODUCTS, I510(k) NO: K001965(TRADITIONAL) ATTN: ARTHUR GIANAKOS PHONE NO : 518-218-0402 3 WALKER WAY SE DECISION MADE: 02-FEB-01 ALBANY, NY 12205 510(k) STATEMENT DEVICE: COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX NOVARTIS NUTRITION CORP. 510(k) NO: K001916(TRADITIONAL) ATTN: SHARON MARTIN PHONE NO : 612-591-2976 5320 WEST 23RD STREET SE DECISION MADE: 16-FEB-01 PO BOX 370 510(k) SUMMARY AVAILABLE FROM FDA MINNEAPOLIS, MN 55440 DEVICE: SELECT SEED I-125 NUCLETRON CORPORATION 510(k) NO: K002429(TRADITIONAL) ATTN: ROBERT APPLEBAUM PHONE NO : 410-312-4103 7080 COLUMBIA GATEWAY DRIVE SE DECISION MADE: 02-FEB-01 COLUMBIA, MD 21046 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUF OCU-EASE OPTICAL PRODUCTS, INC. 510(k) NO: K003996(TRADITIONAL) ATTN: CHARLES R VERMETTE PHONE NO : 800-521-8984 629 TENNENT AVE SE DECISION MADE: 21-FEB-01 PINOLE, CA 94564 510(k) STATEMENT DEVICE: OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOX OCU-EASE OPTICAL PRODUCTS, INC. 510(k) NO: K004000(TRADITIONAL) ATTN: CHARLES R VERMETTE PHONE NO : 800-521-8984 629 TENNENT AVE SE DECISION MADE: 21-FEB-01 PINOLE, CA 94564 510(k) STATEMENT DEVICE: OLYMPUS ENDOSCOPIC LIGATION DEVICE OLYMPUS AMERICA, INC. 510(k) NO: K001744(TRADITIONAL) ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688 TWO CORPORATE CENTER DR. SE DECISION MADE: 27-FEB-01 MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SALUTE ONUX MEDICAL, INC. 510(k) NO: K003522(TRADITIONAL) ATTN: GREGORY E SANCOFF PHONE NO : 603-929-6200 5 MERRILL DR. SE DECISION MADE: 13-FEB-01 HAMPTON, NH 03842 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OPTOVENT AB 510(k) NO: K003704(TRADITIONAL) ATTN: CLAES RYMOND PHONE NO : 201-224-3688 1350 15TH STREET, SUITE 4H SE DECISION MADE: 05-FEB-01 FORT LEE, NJ 07024 510(k) STATEMENT DEVICE: PROCLUDE-SENSITIVE ORTEK THERAPEUTICS, INC. 510(k) NO: K003482(TRADITIONAL) ATTN: JULES T MITCHEL PHONE NO : 212-681-2100 305 MADISON AVENUE SE DECISION MADE: 01-FEB-01 SUITE 2501 510(k) SUMMARY AVAILABLE FROM FDA NEW YORK, NY 10165 DEVICE: LIVESURE THC SCREEN TEST PAN PROBE, INC. 510(k) NO: K010001(TRADITIONAL) ATTN: ALICE H YU PHONE NO : 858-689-9936 8515 ARJONS DR., SUITE A SE DECISION MADE: 05-FEB-01 SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FLUOROPERM 151-OK, PARAGON HDS 100-OK PARAGON VISION SCIENCES 510(k) NO: K010109(TRADITIONAL) ATTN: WILLIAM E MEYERS PHONE NO : 480-507-7606 947 EAST IMPALA AVE. SE DECISION MADE: 28-FEB-01 MESA, AZ 85204 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARE ENDOSCOPIC SUTURING SYSTEM PARE SURGICAL, INC. 510(k) NO: K003102(TRADITIONAL) ATTN: RICHARD P FLEENOR PHONE NO : 303-689-0187 7332 SOUTH ALTON WAY, UNIT H SE DECISION MADE: 27-FEB-01 ENGLEWOOD, CO 80112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LA PERUSAHAAN GETAH ASAS SDN BHD 510(k) NO: K003737(TRADITIONAL) ATTN: TAN KONG CHANG PHONE NO : 603 391 1949 LOT 754, JALAN HAJI SIRAT SE DECISION MADE: 01-FEB-01 SELANGOR, MALAYSIA 41720 510(k) STATEMENT DEVICE: MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175 PHAMATECH 510(k) NO: K003858(TRADITIONAL) ATTN: CARL A MONGIOVI PHONE NO : 858-635-5840 9520 PADGETT STREET #101 SE DECISION MADE: 12-FEB-01 SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANNULATED SCREW SYSTEM PIONEER LABORATORIES, INC. 510(k) NO: K003496(TRADITIONAL) ATTN: AMY H MOMMAERTS PHONE NO : 906-226-9909 375 RIVER PARK CIRCLE SE DECISION MADE: 08-FEB-01 MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY POLYMER TECHNOLOGY 510(k) NO: K003932(TRADITIONAL) ATTN: NANCY ABRAHAM PHONE NO : 716-338-8227 1400 N GOODMAN STREET SE DECISION MADE: 16-FEB-01 ROCHESTER, NY 14603-0450 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY POLYMER TECHNOLOGY 510(k) NO: K003933(TRADITIONAL) ATTN: NANCY ABRAHAM PHONE NO : 716-338-8227 1400 N GOODMAN STREET SE DECISION MADE: 16-FEB-01 ROCHESTER, NY 14603-0450 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENVIVE MINIFORMS PROCTER & GAMBLE CO. 510(k) NO: K003843(TRADITIONAL) ATTN: KATHLEEN C BLIEZNER PHONE NO : 513-634-3265 6110 CENTER HILL AVENUE SE DECISION MADE: 08-FEB-01 CINCINNATI, OH 45224 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION G PWA INDUSTRIES SDN. BHD. 510(k) NO: K010077(TRADITIONAL) ATTN: K. KARUNAKARAN PHONE NO : 001 609 5670835 LOT 93, SEMAMBU INDUST. ESTATE SE DECISION MADE: 28-FEB-01 KUANTAN, PAHANG, MALAYSIA 25350 510(k) STATEMENT DEVICE: COMFOR-CLINER RECLINER CARE, INC. 510(k) NO: K010194(TRADITIONAL) ATTN: MARK D BROWN PHONE NO : 210-496-0915 122 AVENIDA DEL SOL SE DECISION MADE: 15-FEB-01 SAN ANTONIO, TX 78232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REMVIEW SLEEP RECORDER, MODEL 320 RESPIRONICS, INC. 510(k) NO: K003499(ABBREVIATED) ATTN: DAVID J VANELLA PHONE NO : 724-733-5866 1001 MURRY RIDGE LANE SE DECISION MADE: 09-FEB-01 MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COBAS INTEGRA AMPHETAMINES ROCHE DIAGNOSTICS CORP. 510(k) NO: K003865(TRADITIONAL) ATTN: JENNIFER TRIBBETT PHONE NO : 317-576-3742 9115 HAGUE RD. SE DECISION MADE: 28-FEB-01 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS HCG+B CALCHECK ROCHE DIAGNOSTICS CORP. 510(k) NO: K010237(TRADITIONAL) ATTN: HELEN T TORNEY PHONE NO : 317-576-7643 9115 HAGUE RD. SE DECISION MADE: 14-FEB-01 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WRISTWATCH BLOOD PRESSURE MONITOR, MODEL A43 ROSSMAX INTERNATIONL LTD. 510(k) NO: K010190(SPECIAL) ATTN: MICHAEL YEH PHONE NO : 011 886 226597888 12F, NO. 189, KANG CHIEN RD. SE DECISION MADE: 08-FEB-01 TAIPEI, CHINA (TAIWAN) 114 510(k) STATEMENT DEVICE: RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM RUSCH INTL. 510(k) NO: K010068(ABBREVIATED) ATTN: KARENANN J BROZOWSKI PHONE NO : 603-532-7706 50 PLANTATION DRIVE SE DECISION MADE: 08-FEB-01 JAFFERY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LC PROVIFILL S & C POLYMER GMBH 510(k) NO: K010012(TRADITIONAL) ATTN: JURGEN ENGELBRECHT PHONE NO : 004 941 214830 ROBERT-BOSCH-STRASSE 5 SE DECISION MADE: 14-FEB-01 ELMSHORN, GERMANY D-25335 510(k) STATEMENT DEVICE: THERMO TEK IR FOREHEAD THERMOMETER, MODEL 718F S.A.A.T., LTD. 510(k) NO: K002712(TRADITIONAL) ATTN: SHOSHANA FRIEDMAN PHONE NO : 972 977 18130 117 AHUZAH ST. SE DECISION MADE: 08-FEB-01 PUSH-MED LTD 510(k) SUMMARY AVAILABLE FROM FDA RA'ANANNA, ISRAEL 43373 DEVICE: MODEL THERMO TEK QUICKCARE SAAT LTD. 510(k) NO: K010502(TRADITIONAL) ATTN: E. J SMITH PHONE NO : 410-451-0639 1468 HARWELL AVENUE SE DECISION MADE: 27-FEB-01 CROFTON,, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NONSTERILE POWDERED PURPLE LATEX EXAMINATION GLOVES, WITH & WITH SGMP CO., LTD. 510(k) NO: K010095(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 09-FEB-01 SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHANGHAI CHINASTAR POWER-FREE BLUE NITRIL EXAMINATION GLOVES SHANGHAI CHINASTAR CORP. 510(k) NO: K010247(TRADITIONAL) ATTN: LEE HUNG TE CHIH PHONE NO : 886 227 138677 NO. 283, CHE XING ROAD SE DECISION MADE: 06-FEB-01 CHE DUN ZHEN,SONG JIANG COUNTY 510(k) SUMMARY AVAILABLE FROM FDA SHANGHAI, CHINA THIRD PARTY REVIEW DEVICE: ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-220 SHIMADZU MEDICAL SYSTEMS 510(k) NO: K003514(TRADITIONAL) ATTN: MASAAKI SHIBATA PHONE NO : 310-217-8855 20101 SOUTH VERMONT AVE. SE DECISION MADE: 12-FEB-01 TORRANCE, CA 90502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-120 SHIMADZU MEDICAL SYSTEMS 510(k) NO: K003515(TRADITIONAL) ATTN: MASAAKI SHIBATA PHONE NO : 310-217-8855 20101 SOUTH VERMONT AVE. SE DECISION MADE: 12-FEB-01 TORRANCE, CA 90502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REGUTHERM 952 THERMOGRAPHIC SYSTEM SIE-MED, INC. 510(k) NO: K003130(TRADITIONAL) ATTN: CHARLES H KYPER PHONE NO : 301-776-3546 11902 SIMPSON ROAD SE DECISION MADE: 16-FEB-01 CLARKSVILLE, MD 21029 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPDIMA SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K003945(TRADITIONAL) ATTN: PRAVEEN NADKARNI PHONE NO : 732-321-4950 186 WOOD AVENUE SOUTH SE DECISION MADE: 02-FEB-01 ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORBITER II CCI/SPECT ORBITER I SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K010137(SPECIAL) ATTN: RONALD NOLTE PHONE NO : 847-304-7504 2501 NORTH BARRINGTON RD. SE DECISION MADE: 13-FEB-01 HOFFMAN ESTATES, IL 60195-7372 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECTROSTATIC HYDROPHOBIC BREATHING FILTER SIMS PORTEX, INC. 510(k) NO: K002201(TRADITIONAL) ATTN: TIMOTHY J TALCOTT PHONE NO : 603-352-3812 10 BOWMAN DR. SE DECISION MADE: 05-FEB-01 KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS SMITH & NEPHEW, INC. 510(k) NO: K003566(TRADITIONAL) ATTN: DAVID HENLEY PHONE NO : 901-399-6487 1450 E. BROOKS ROAD SE DECISION MADE: 14-FEB-01 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYONICS CONTROL RF SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K003572(TRADITIONAL) ATTN: MARK KIERAS PHONE NO : 978-749-1121 160 DASCOMB RD. SE DECISION MADE: 15-FEB-01 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW SUTURE ANCHOR SMITH & NEPHEW, INC. 510(k) NO: K003599(TRADITIONAL) ATTN: WILLIAM MCCALLUM PHONE NO : 508-261-3620 160 DASCOMB RD. SE DECISION MADE: 15-FEB-01 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048; DYONI SMITH & NEPHEW, INC. 510(k) NO: K003710(TRADITIONAL) ATTN: JANICE HASELTON PHONE NO : 978-749-1494 160 DASCOMB RD. SE DECISION MADE: 02-FEB-01 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONOSITE HAND-CARRIED ULTRASOUND SYSTEM SONOSITE,INC. 510(k) NO: K010374(TRADITIONAL) ATTN: MICHAEL A HOFFMAN PHONE NO : 425-951-1297 21919 30TH DRIVE SE. SE DECISION MADE: 21-FEB-01 BOTHELL, WA 98021-3904 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SPECIALTY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS SPECIALTY ULTRAVISION, INC. 510(k) NO: K003526(TRADITIONAL) ATTN: GAROLD L EDWARDS PHONE NO : 408-341-0700 307 ORCHARD CITY DRIVE SE DECISION MADE: 12-FEB-01 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA CAMPBELL, CA 95008 DEVICE: SPECIALITY 56 UV (HEFILCON C) SOFT (HYDROPHILLIC) CONTACT LENS F SPECIALTY ULTRAVISION, INC. 510(k) NO: K003789(TRADITIONAL) ATTN: DEBBIE MCINTIRE PHONE NO : 408-341-0700 307 ORCHARD CITY DRIVE SE DECISION MADE: 21-FEB-01 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA CAMPBELL, CA 95008 DEVICE: ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055 ST. FRANCIS MEDICAL EQUIPMENT CO.,510(k) NO: K003423(TRADITIONAL) ATTN: FRANCIS HONG PHONE NO : 886 222 781555 P.O. BOX 129 SE DECISION MADE: 22-FEB-01 SHIEN CHUANG 24299 510(k) SUMMARY AVAILABLE FROM FDA TAIPEI SHIEN, TAIWAN, R.O.C., CHINA (TAIWAN) DEVICE: PROTRACT PRESS FIT HIP STEM-HA COATED STELKAST CO. 510(k) NO: K010241(SPECIAL) ATTN: DONALD A STEVENS PHONE NO : 412-322-8280 800 VINIAL ST. #210 SE DECISION MADE: 08-FEB-01 PITTSBURGH, PA 15212 510(k) STATEMENT DEVICE: LATERAL OFFSET PROTRACT PRESS FIT HIP STEM STELKAST CO. 510(k) NO: K010282(SPECIAL) ATTN: DONALD A STEVENS PHONE NO : 412-322-8280 800 VINIAL ST. #210 SE DECISION MADE: 09-FEB-01 PITTSBURGH, PA 15212 510(k) STATEMENT DEVICE: VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 6000 STERINC 510(k) NO: K002912(TRADITIONAL) ATTN: GARY FRUGARD PHONE NO : 949-493-5829 3520 W. WARNER AVENUE SE DECISION MADE: 21-FEB-01 SANTA ANTA, CA 92704 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L STERITEC PRODUCTS, INC. 510(k) NO: K003533(ABBREVIATED) ATTN: LINDA NELSON PHONE NO : 303-660-4201 599 TOPEKA WAY, SUITE 700 SE DECISION MADE: 07-FEB-01 CASTLE ROCK, CO 80104 510(k) STATEMENT DEVICE: STRYKER HEATED INSUFFLATOR TUBE SET STRYKER CORP. 510(k) NO: K003792(TRADITIONAL) ATTN: MICHAEL BAYCURA PHONE NO : 408-567-9100 2590 WALSH AVE. SE DECISION MADE: 21-FEB-01 SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANATOMICAL PRESS-FIT HUMERAL STEM SULZER ORTHOPEDICS, INC. 510(k) NO: K003801(TRADITIONAL) ATTN: MITCHELL A DHORITY PHONE NO : 512-432-9202 9900 SPECTRUM DR. SE DECISION MADE: 28-FEB-01 AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERILE POWDERED LATEX SURGEON GLOVES SUPERMAX GLOVE MANUFACTURING SDN B510(k) NO: K010198(TRADITIONAL) ATTN: STANLEY THAI PHONE NO : 603 615 72328 47000 SUNGAI BULOH SE DECISION MADE: 23-FEB-01 SELANGOR, MALAYSIA 510(k) STATEMENT DEVICE: SURGI-VISION GUIDEWIRE COIL SURGI-VISION, INC. 510(k) NO: K003436(TRADITIONAL) ATTN: NANCY E TALOR PHONE NO : 410-730-8998 9250 RUMSEY RD., SUITE 100 SE DECISION MADE: 02-FEB-01 COLUMBIA, MD 21045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIRSTSAVE BIPHASIC MODEL #9200 AND 9210 SURVIVALINK CORP. 510(k) NO: K010214(SPECIAL) ATTN: SEW-WAH TAY PHONE NO : 952-939-4181 5420 FELTL RD. SE DECISION MADE: 22-FEB-01 MINNEAPOLIS, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINIENDO III SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K003640(TRADITIONAL) ATTN: COLLEEN BOSELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVENUE SE DECISION MADE: 22-FEB-01 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERMLASTIC 3 SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K003650(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVENUE SE DECISION MADE: 15-FEB-01 ORANGE, CA 92667 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR SYNERGENT BIOCHEM INC.-CLINICAL CO510(k) NO: K010030(TRADITIONAL) ATTN: JAMES F GODFREY PHONE NO : 800-585-8580 12038 CENTRAILIA AVE SE DECISION MADE: 14-FEB-01 SUITE C 510(k) SUMMARY AVAILABLE FROM FDA HAWAIIAN GARDENS, CA 90716 DEVICE: SYNTHES HAMSTRING LOOP SYNTHES (USA) 510(k) NO: K003700(TRADITIONAL) ATTN: THOMAS M MAGUIRE PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 20-FEB-01 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM SYNTHES (USA) 510(k) NO: K003743(TRADITIONAL) ATTN: ANGELA J SILVESTRI PHONE NO : 610-647-9700 1690 RUSSELL ROAD SE DECISION MADE: 09-FEB-01 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMF RESORBABLE MESHES AND SHEETS SYNTHES (USA) 510(k) NO: K003786(TRADITIONAL) ATTN: THOMAS M MAGUIRE PHONE NO : 610-647-9700 P.O. BOX 1766 SE DECISION MADE: 27-FEB-01 1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301-1222 DEVICE: STERILE BUTTON PLATE SYNTHES (USA) 510(k) NO: K010121(SPECIAL) ATTN: THOMAS M MAGUIRE PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 09-FEB-01 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TAUT-INSUFFLATION NEEDLE TAUT, INC. 510(k) NO: K003703(TRADITIONAL) ATTN: RONALD KENSETH PHONE NO : 630-232-2507 2571 KANEVILLE COURT SE DECISION MADE: 22-FEB-01 GENEVA, IL 60134 510(k) STATEMENT DEVICE: ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP TAUT, INC. 510(k) NO: K010007(TRADITIONAL) ATTN: RONALD KENSETH PHONE NO : 630-232-8005 2571 KANEVILLE COURT SE DECISION MADE: 22-FEB-01 GENEVA, IL 60134 510(k) STATEMENT DEVICE: TE ME NA EPIDURAL CATHETER TE ME NA S.A.R.L. 510(k) NO: K991259(TRADITIONAL) ATTN: ARTHUR WARD PHONE NO : 813-645-2855 390 SCARLET BLVD SE DECISION MADE: 21-FEB-01 OLDSMAR, FL 34677 510(k) STATEMENT DEVICE: A & I WHEELCHAIRS TECH-MED SERVICES, INC. 510(k) NO: K010094(TRADITIONAL) ATTN: RICHARD GRAVER PHONE NO : 631-582-7320 933A MOTOR PARKWAY SE DECISION MADE: 15-FEB-01 HAUPPAQUE, NY 11788 510(k) STATEMENT DEVICE: TENSCARE, MODEL TENS XL-2 TENS CARE LTD. 510(k) NO: K003591(TRADITIONAL) ATTN: BERNARD J TREMAINE PHONE NO : 441 019 804310 76, STOCKPORT ROAD SE DECISION MADE: 14-FEB-01 TIMPERLRY, UNITED KINGDOM WA15 7SN510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MTP RESESURFACING JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/930 TERRAY CORP. 510(k) NO: K003629(TRADITIONAL) ATTN: STEVE WANG PHONE NO : 613 623 3310 49 JACKSON LANE SE DECISION MADE: 22-FEB-01 ARNPRIOR, CANADA K7S3G8 510(k) STATEMENT DEVICE: ADAPTERS WITH X-COATING TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K003604(TRADITIONAL) ATTN: GARRY A COURTNEY PHONE NO : 800-283-7866 125 BLUE BALL ROAD SE DECISION MADE: 07-FEB-01 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLIRANS E-SERIES HOLLOW FIBER DIALYZERS TERUMO MEDICAL CORPORATION 510(k) NO: K003425(TRADITIONAL) ATTN: YUK-TING LEWIS PHONE NO : 410-392-7213 125 BLUE BALL ROAD SE DECISION MADE: 01-FEB-01 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML S TERUMO MEDICAL CORPORATION 510(k) NO: K003571(ABBREVIATED) ATTN: BARBARA SMITH PHONE NO : 410-392-7241 125 BLUE BALL ROAD SE DECISION MADE: 12-FEB-01 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KAPPA IMMAGE FREELITE KIT THE BINDING SITE, LTD. 510(k) NO: K003669(TRADITIONAL) ATTN: JAY H GELLER PHONE NO : 310-449-1399 WEST TOWER, SUITE 4000 SE DECISION MADE: 01-FEB-01 2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT SANTA MONICA, CA 90404 DEVICE: LAMBDA IMMAGE FREELITE KIT THE BINDING SITE, LTD. 510(k) NO: K003671(TRADITIONAL) ATTN: JAY H GELLER PHONE NO : 310-449-1399 WEST TOWER, SUITE 4000 SE DECISION MADE: 01-FEB-01 2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT SANTA MONICA, CA 90404 DEVICE: ANA EIA DIAGNOSTIC TEST KIT THE BINDING SITE, LTD. 510(k) NO: K004019(TRADITIONAL) ATTN: JAY H GELLER PHONE NO : 310-449-1399 WEST TOWER, SUITE 4000 SE DECISION MADE: 15-FEB-01 2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT SANTA MONICA, CA 90404 DEVICE: ENA SCREEN EIA KIT THE BINDING SITE, LTD. 510(k) NO: K010148(TRADITIONAL) ATTN: JAY H GELLER PHONE NO : 310-449-1399 WEST TOWER, SUITE 4000 SE DECISION MADE: 23-FEB-01 2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT SANTA MONICA, CA 90404 DEVICE: ACTICOAT FOAM DRESSING, ALGISITE M CALCIUM ALGINATE DRESSING THE WESTAIM CORP. 510(k) NO: K002896(TRADITIONAL) ATTN: STEVEN CHARTIER PHONE NO : 603-775-7300 1 HAMPTON RD., #302 SE DECISION MADE: 21-FEB-01 EXETER, NH 03833-4807 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN C TILLOTSON HEALTHCARE CORPORATION 510(k) NO: K004048(TRADITIONAL) ATTN: F.W. PERRELLA PHONE NO : 603-472-6600 360 ROUTE 101 SE DECISION MADE: 06-FEB-01 BEDFORD, NH 03110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PALFIQUE ESTELITE LV CLEAR TOKUYAMA AMERICA, INC. 510(k) NO: K010267(TRADITIONAL) ATTN: DANIEL J MANELLI PHONE NO : 202-261-1040 2000 M STREET (SUITE 700) SE DECISION MADE: 27-FEB-01 WASHINGTON, DC 20036 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING TOMTEC IMAGING SYSTEMS, GMBH 510(k) NO: K003936(TRADITIONAL) ATTN: FLORIAN EISENBERGER PHONE NO : 011 49 8932175830 EDISONSTRASSE 6 SE DECISION MADE: 14-FEB-01 UNTERSCHLEISSHEIM, GERMANY D-85716510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WATER PURIFICATION SYSTEM FOR HEMODIALYSIS TOTAL WATER TREATMENT SYSTEMS, INC510(k) NO: K002045(TRADITIONAL) ATTN: KENNETH J CLARK PHONE NO : 608-221-2236 4806 EAST BROADWAY SE DECISION MADE: 16-FEB-01 MADISON, WI 53716 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K003834(TRADITIONAL) ATTN: CYNTHIA C KNAPP PHONE NO : 800-216-9036 29299 CLEMENS RD., SUITE 1-K SE DECISION MADE: 23-FEB-01 WESTLAKE, OH 44145 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSITIRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K003868(TRADITIONAL) ATTN: CYNTHIA C KNAPP PHONE NO : 800-216-9036 29299 CLEMENS RD., SUITE 1-K SE DECISION MADE: 27-FEB-01 WESTLAKE, OH 44145 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870 TUTTNAUER CO. LTD. 510(k) NO: K003470(ABBREVIATED) ATTN: MARK YACURA PHONE NO : 202-452-7949 1776 K STREET N.W. SE DECISION MADE: 20-FEB-01 SUITE 800 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20006-2365 DEVICE: TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP TUTTNAUER USA CO. LTD. 510(k) NO: K993856(TRADITIONAL) ATTN: MARK M YACURA PHONE NO : 202-452-7949 1776 K STREET, N.W. SE DECISION MADE: 09-FEB-01 SUITE 800 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20006-7910 DEVICE: PALMLIGHT ULTRADENT PRODUCTS, INC. 510(k) NO: K003383(TRADITIONAL) ATTN: MARKUS R GEE PHONE NO : 800-552-5512 505 WEST 10200 SOUTH SE DECISION MADE: 06-FEB-01 SOUTH JORDAN, UT 84065 510(k) STATEMENT DEVICE: MODIFICATION TO CAVERMAP SURGICAL AID UROMED CORP. 510(k) NO: K010098(SPECIAL) ATTN: FREDERICK TOBIA PHONE NO : 781-762-2080 1400 PROVIDENCE HWY. SE DECISION MADE: 01-FEB-01 NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORTALVISION VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K003636(TRADITIONAL) ATTN: LINDA S NASH PHONE NO : 650-424-6990 3100 HANSEN WAY SE DECISION MADE: 02-FEB-01 PALO ALTO, CA 94304-1129 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASCULAR ARCHITECTS PERISCOPE DEVICE VASCULAR ARCHITECTS, INC. 510(k) NO: K003719(TRADITIONAL) ATTN: JEAN M CAILLOUETTE PHONE NO : 408-392-7437 1830 BERING DR. SE DECISION MADE: 28-FEB-01 SAN JOSE, CA 95112-4226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM VIDAMED, INC. 510(k) NO: K002583(TRADITIONAL) ATTN: TOM MCGAFFIGAN PHONE NO : 510-492-4930 46107 LANDING PKWY. SE DECISION MADE: 13-FEB-01 FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500 VISUALIZATION TECHNOLOGY, INC. 510(k) NO: K003510(TRADITIONAL) ATTN: NORMA LEMAY PHONE NO : 978-933-1000 200 RESEARCH DR. SE DECISION MADE: 12-FEB-01 WILMINGTON, MA 01887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONYX-RAD TELEMEDICINE PACS VIZTEK, INC. 510(k) NO: K003607(TRADITIONAL) ATTN: JOSIP CERMIN PHONE NO : 904-733-3656 6491 POWERS AVE. SE DECISION MADE: 15-FEB-01 JACKSONVILLE, FL 32217 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERCUSSIVENEB, MODEL PN-2001 VORTRAN MEDICAL TECHNOLOGY 1, INC.510(k) NO: K003684(SPECIAL) ATTN: GORDON A WONG PHONE NO : 916-733-6870 3941 J ST., SUITE 354 SE DECISION MADE: 23-FEB-01 SACRAMENTO, CA 95819 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) W & H DENTALWERK BUERMOOS GMBH 510(k) NO: K002469(TRADITIONAL) ATTN: HERBERT TRASCHWANDTNER PHONE NO : 011 436 27462360 IGNAZ GLASER STR. 53 SE DECISION MADE: 07-FEB-01 A-5111 510(k) STATEMENT BUERMOOS, AUSTRIA A-5111 DEVICE: GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES W.L. GORE & ASSOCIATES,INC 510(k) NO: K010228(SPECIAL) ATTN: R. LARRY PRATT PHONE NO : 800-528-1866 3750 WEST KILTIE LN. SE DECISION MADE: 21-FEB-01 FLAGSTAFF, AZ 86002-0900 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DELFIA NEONATAL IRT KIT, MODEL A005-110 WALLAC OY 510(k) NO: K003664(TRADITIONAL) ATTN: GUNNEL LAAKSONEN PHONE NO : 358 226 78111 MUSTIONKATU 6 SE DECISION MADE: 14-FEB-01 TURKU, FINLAND 20750 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTODELFIA NEONATAL IRT KIT, MODEL B005-112 WALLAC OY 510(k) NO: K003668(TRADITIONAL) ATTN: GUNNEL LAAKSONEN PHONE NO : 358 226 78111 MUSTIONKATU 6 SE DECISION MADE: 12-FEB-01 TURKU, FINLAND 20750 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LORENZ RESORBABLE DISTRACTOR SYSTEM WALTER LORENZ SURGICAL, INC. 510(k) NO: K002083(TRADITIONAL) ATTN: STEVE HERRINGTON PHONE NO : 904-741-4400 1520 TRADEPORT DR. SE DECISION MADE: 12-FEB-01 JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE WANDY RUBBER INDUSTRIAL CO., LTD 510(k) NO: K002219(TRADITIONAL) ATTN: JANIS YANG PHONE NO : 886 269 43184 NO. 22, ALLAY 37, LANE 266 SE DECISION MADE: 02-FEB-01 FU TEH I RD. 510(k) STATEMENT SHI-CHIH, TAIPEI, CHINA (TAIWAN) DEVICE: WANDY SILICONE CONDUCTIVE RUBBER PAD WANDY RUBBER INDUSTRIAL CO., LTD 510(k) NO: K002227(TRADITIONAL) ATTN: JANIS YANG PHONE NO : 886 269 43184 NO. 22, ALLAY 37, LANE 266 SE DECISION MADE: 02-FEB-01 FU TEH I RD. 510(k) STATEMENT SHI-CHIH, TAIPEI, CHINA (TAIWAN) DEVICE: CLEAN SCRAPE WEBB RESEARCH II, INC. 510(k) NO: K003773(TRADITIONAL) ATTN: STEVEN KRUPNICK PHONE NO : 215-336-5570 1241 CARPENTER STREET SE DECISION MADE: 02-FEB-01 PHILADELPHIA, PA 19147 510(k) STATEMENT DEVICE: ACTICOAT COMPOSITE DRESSING WESTAIM BIOMEDICAL, INC. 510(k) NO: K002466(TRADITIONAL) ATTN: STEVE CHARTIER PHONE NO : 603-775-7300 ONE HAMPTON RD. SUITE 302 SE DECISION MADE: 16-FEB-01 EXETER, NH 03833 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENGPLUS WESTERN SYSTEMS RESEARCH, INC. 510(k) NO: K010059(TRADITIONAL) ATTN: LINDA DAVIS-O'LEARY PHONE NO : 626-578-7363 260 S. LOS ROBLES AVE. STE 106 SE DECISION MADE: 27-FEB-01 PASADENA, CA 91101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERFECTA AND EXTEND WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K004032(ABBREVIATED) ATTN: EHAB M ESMAIL PHONE NO : 901-867-4732 5677 AIRLINE RD. SE DECISION MADE: 15-FEB-01 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER ZCV ,INC. 510(k) NO: K010099(SPECIAL) ATTN: JING ZHANG PHONE NO : 732-225-3800 298 FERNWOOD AVE. SE DECISION MADE: 01-FEB-01 EDISON, NJ 08837 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIOLOGY ACETABULAR SYSTEM 46MM LARGE HEAD LINERS, MODEL 6310 ZIMMER, INC. 510(k) NO: K003478(TRADITIONAL) ATTN: KAREN CAIN PHONE NO : 219-372-4219 P.O. BOX 708 SE DECISION MADE: 05-FEB-01 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZOLL M SERIES ZOLL MEDICAL CORP. 510(k) NO: K010257(SPECIAL) ATTN: PAUL DIAS PHONE NO : 781-229-0020 32 SECOND AVE. SE DECISION MADE: 28-FEB-01 BURLINGTON, MA 01803 510(k) STATEMENT TOTAL 510(k)s THIS PERIOD 265 TOTAL WITH SUMMARIES 190 TOTAL WITH STATEMENTS 75
Updated 5/10/2002
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