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510(k)s Final Decisions Rendered for February 1999 |
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-FEB-99 THROUGH 28-FEB-99 DEVICE: AARON ESU FOOT-CONTROL ADAPTER #A1205A AARON MEDICAL INDUSTRIES 510(k) NO: K984236(TRADITIONAL) ATTN: J. ROBERT SARON PHONE NO : 727-384-2323 7100 30TH AVE. NORTH SE DECISION MADE: 10-FEB-99 ST. PETERSBURG, FL 33710-2902 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SLICKTIP SOLID LAPAROSCOPIC ELECTRODE, MODELS LH01Z, LB02Z, LN03 AARON MEDICAL INDUSTRIES 510(k) NO: K984239(TRADITIONAL) ATTN: J. ROBERT SARON PHONE NO : 727-384-2323 7100 30TH AVE. NORTH SE DECISION MADE: 10-FEB-99 ST. PETERSBURG, FL 33710-2902 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYSTEM U3 AB BIODISK 510(k) NO: K983890(TRADITIONAL) ATTN: ANNE BOLSTROM PHONE NO : 468 730 0760 DALVAGEN 10, S-169 56 SE DECISION MADE: 18-FEB-99 SOLNA, SWEDEN 510(k) STATEMENT DEVICE: SYSTEM U3 FOR AMPICILLIN AB BIODISK 510(k) NO: K984087(TRADITIONAL) ATTN: ANNE BOLMSTROM PHONE NO : 46 8 730 07 60 DALVAGEN 10 SE DECISION MADE: 08-FEB-99 SOLNA, SWEDEN 16956 510(k) STATEMENT DEVICE: SYSTEM U3 FOR AMOXICILLIN/CLAVULANIC ACID AB BIODISK 510(k) NO: K984144(TRADITIONAL) ATTN: ANNE BOLMSTROM PHONE NO : 468 730 0760 DALVAGEN 10, S-169 56 SE DECISION MADE: 09-FEB-99 SOLNA, SWEDEN 510(k) STATEMENT DEVICE: CK ABBOTT LABORATORIES 510(k) NO: K983070(TRADITIONAL) ATTN: LINDA MORRIS PHONE NO : 972-518-6711 1920 HURD SE DECISION MADE: 16-FEB-99 IRVING, TX 75062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABBOTT ARCHITECT B12 ABBOTT LABORATORIES 510(k) NO: K984108(TRADITIONAL) ATTN: LAURA L GRANITZ PHONE NO : 847-938-0092 200 ABBOTT PARK ROAD SE DECISION MADE: 03-FEB-99 ABBOTT PARK, IL 60064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABBOTT ARCHITECT FOLATE ABBOTT LABORATORIES 510(k) NO: K984301(TRADITIONAL) ATTN: LAURA L GRANITZ PHONE NO : 847-937-3340 200 ABBOTT PARK ROAD SE DECISION MADE: 05-FEB-99 ABBOTT PARK, IL 60064-3537 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FACT PLUS ONE STEP PREGNANCY TEST ABBOTT LABORATORIES 510(k) NO: K990373(SPECIAL) ATTN: KATHERINE M WORTLEY PHONE NO : 847-938-7707 DEPT 49C, BIDG. AP31 SE DECISION MADE: 22-FEB-99 200 ABBOTT PARK ROAD 510(k) SUMMARY AVAILABLE FROM FDA ABBOTT PARK, IL 60064-6200 DEVICE: SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES ACCUMED INTL., INC. 510(k) NO: K984489(TRADITIONAL) ATTN: CYNTHIA C KNAPP PHONE NO : 800-871-8909 29299 CLEMENS RD., SUITE 1-K SE DECISION MADE: 16-FEB-99 WESTLAKE, OH 44145 510(k) STATEMENT DEVICE: ACIST INJECTOR SYSTEM, MODEL CL100 H ACIST MEDICAL SYSTEMS 510(k) NO: K984058(TRADITIONAL) ATTN: KATE ANDERSON PHONE NO : 612-941-3507 10250 VALLEY VIEW RD., #117 SE DECISION MADE: 11-FEB-99 EDEN PRAIRIE, MN 55344 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHOFIL NONABSORBABLE PET SURGICAL SUTURE AESCULAP 510(k) NO: K990088(TRADITIONAL) ATTN: STEVE REITZLER PHONE NO : 619-702-0700 ONE AMERICA PLAZA, SUITE 900 SE DECISION MADE: 10-FEB-99 600 WEST BROADWAY 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92101-3302 DEVICE: AESCULAP AXIAL CLIP APPLIER AESCULAP, INC. 510(k) NO: K984109(TRADITIONAL) ATTN: LIA S JONES PHONE NO : 650-624-5073 1000 GATEWAY BLVD. SE DECISION MADE: 12-FEB-99 SOUTH SAN FRANCISCO, CA 94080-7030510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AESCULAP XENON LIGHT SOURCE AESCULAP, INC. 510(k) NO: K984124(TRADITIONAL) ATTN: MARY ELLEN HOLDEN PHONE NO : 650-624-5072 1000 GATEWAY BLVD. SE DECISION MADE: 01-FEB-99 SOUTH SAN FRANCISCO, CA 94080-7030510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II ALARIS MEDICAL SYSTEMS, INC. 510(k) NO: K983626(ABBREVIATED) ATTN: GARY N MILLS PHONE NO : 503-681-9000 7431 NW EVERGREEN PARKWAY SE DECISION MADE: 05-FEB-99 HILLSBORO, OR 97124-5898 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BROWNE SPORICIDIN PHENOL INDICATOR FOR SPORICIDIN STERILIZING AN ALBERT BROWNE LTD. 510(k) NO: K984613(TRADITIONAL) ATTN: CYNTHIA NOLTE PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 04-FEB-99 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BROWNE SPORICIDIN GLUTARALDEHYDE INDICATOR FOR SPORICIDIN STERIL ALBERT BROWNE LTD. 510(k) NO: K984616(TRADITIONAL) ATTN: CYNTHIA J.M. NOLTE PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 04-FEB-99 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K984075(TRADITIONAL) ATTN: NAISHU WANG PHONE NO : 619-350-9798 11494 SORRENTO VALLEY RD., SE DECISION MADE: 16-FEB-99 SUITE F/M 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92121 DEVICE: INSTANT-VIEW PREGNANCY URINE TEST ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K984076(TRADITIONAL) ATTN: NAISHU WANG PHONE NO : 619-350-9798 11494 SORRENTO VALLEY RD., SE DECISION MADE: 16-FEB-99 SUITE F/M 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92121 DEVICE: INSTANT-VIEW PREGNANCY COMBO TEST ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K984077(TRADITIONAL) ATTN: NAISHU WANG PHONE NO : 619-350-9798 11494 SORRENTO VALLEY RD., SE DECISION MADE: 16-FEB-99 SUITE F/M 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92121 DEVICE: INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K984079(TRADITIONAL) ATTN: NAISHU WANG PHONE NO : 619-350-9798 11494 SORRENTO VALLEY RD., SE DECISION MADE: 16-FEB-99 SUITE F/M 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92121 DEVICE: INSTANT-VIEW PREGNANCY COMBO DIP-STRIP TEST ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K984080(TRADITIONAL) ATTN: NAISHU WANG PHONE NO : 619-350-9798 11494 SORRENTO VALLEY RD., SE DECISION MADE: 16-FEB-99 SUITE F/M 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92121 DEVICE: SUPRASHIELD EXPRESS STERILIZATION WRAP ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K990300(SPECIAL) ATTN: PATRICIA SHARPE-GREGG PHONE NO : 847-578-3636 1500 WAUKEGAN RD. SE DECISION MADE: 10-FEB-99 WILLIAM MERZ BUILDING 510(k) STATEMENT MCGAW PARK, IL 60085 DEVICE: THE GOLDEN TIP ELECTRO-SURGICAL PROBE AMADA SURGICAL 510(k) NO: K984275(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 01-FEB-99 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: "RAPID DRUG SCREEN" 5-PANEL WITH METHAMPHETAMINE TEST AMERICAN BIO MEDICA CORP. 510(k) NO: K984525(TRADITIONAL) ATTN: HENRY WELLS PHONE NO : 800-227-1243 300 FAIRVIEW AVE. SE DECISION MADE: 26-FEB-99 HUDSON, NY 12534 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNISEAL POWDER-FREE LATEX EXAMINATION GLOVES (BLUE & GREEN COLOR AMERICAN HEALTHCARE PRODUCTS (M) S510(k) NO: K983614(TRADITIONAL) ATTN: TARANI DEVI PHONE NO : 603 323 4618 SERULING 59, TAMAN KLANG JAYA SE DECISION MADE: 04-FEB-99 KLANG, MALAYSIA 510(k) STATEMENT DEVICE: DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY ANSELL PERRY 510(k) NO: K984558(TRADITIONAL) ATTN: JAMES R CHATTERTON PHONE NO : 330-833-2811 1875 HARSH AVENUE, S.E. SE DECISION MADE: 26-FEB-99 MASSILLON, OH 44646-7199 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELITE POWDER-FREE POLYURETHANE SYNTHETIC SURGICAL GLOVES (CHEMOT ANSELL PERRY 510(k) NO: K984559(TRADITIONAL) ATTN: JAMES R CHATTERTON PHONE NO : 330-833-2811 1875 HARSH AVENUE, S.E. SE DECISION MADE: 26-FEB-99 MASSILLON, OH 44646-7199 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APPLIED BIOTECH SURESTEP H.PYLORI APPLIED BIOTECH, INC. 510(k) NO: K984393(TRADITIONAL) ATTN: JAMES TUNG PHONE NO : 619-587-6771 10237 FLANDERS CT. SE DECISION MADE: 09-FEB-99 SAN DIEGO, CA 92121 510(k) STATEMENT DEVICE: CARE BAND ANTIBACTERIAL BANDAGES ASO CORP. 510(k) NO: K983368(TRADITIONAL) ATTN: JOAN RUBENDALL PHONE NO : 941-379-0300 300 SARASOTA CENTER BLVD. SE DECISION MADE: 17-FEB-99 SARASOTA, FL 34240 510(k) STATEMENT DEVICE: PERFUSOR COMPACT B. BRAUN MEDICAL, INC. 510(k) NO: K983005(TRADITIONAL) ATTN: GARY A GULYAS PHONE NO : 1601 WALLACE DR., SUITE 150 SE DECISION MADE: 04-FEB-99 CARROLLTON, TX 75006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARDEX LUBRI-SIL FOLEY CATHETER BARD MEDICAL DIV. 510(k) NO: K984084(TRADITIONAL) ATTN: DONNA J WILSON PHONE NO : 770-784-6135 8195 INDUSTRIAL BLVD. SE DECISION MADE: 01-FEB-99 COVINGTON, GA 30209 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARDEX LUBRI-SIL I.C. FOLEY CATHETER BARD MEDICAL DIV. 510(k) NO: K984136(TRADITIONAL) ATTN: DONNA J WILSON PHONE NO : 770-784-6135 8195 INDUSTRIAL BLVD. SE DECISION MADE: 16-FEB-99 COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BURETROL SOLUTION SETS BAXTER HEALTHCARE CORP. 510(k) NO: K984381(TRADITIONAL) ATTN: JUDY KANNENBERG PHONE NO : 847-270-5976 RT. 120 AND WILSON ROAD SE DECISION MADE: 19-FEB-99 ROUND LAKE, IL 60073-0490 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORL-E-92 SURGICAL DRILL SYSTEM BIEN-AIR 510(k) NO: K984244(TRADITIONAL) ATTN: CAROL PATTERSON PHONE NO : 619-451-0642 18140 SMOKESIGNAL DRIVE SE DECISION MADE: 23-FEB-99 SAN DIEGO, CA 92127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES BIO-DETEK, INC. 510(k) NO: K990106(TRADITIONAL) ATTN: MICHAEL R DUPELLE PHONE NO : 401-729-1400 525 NARRAGANSETT PARK DRIVE SE DECISION MADE: 26-FEB-99 PAWTUCKET, RI 02861-4323 510(k) STATEMENT DEVICE: LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220 BIO-RAD LABORATORIES 510(k) NO: K984594(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO RD. SE DECISION MADE: 02-FEB-99 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCHITECT ESTRADIOL MASTERCHEK, MODEL # 6C22-05 BIO-RAD LABORATORIES 510(k) NO: K984604(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-594-1285 9500 JERONIMO ROAD SE DECISION MADE: 02-FEB-99 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCHITECT FOLATE MASTERCHEK, MODEL # 6C12-05 BIO-RAD LABORATORIES 510(k) NO: K984625(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-594-1285 9500 JERONIMO ROAD SE DECISION MADE: 02-FEB-99 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION OF MILLENNIUM BIOLASE TECHNOLOGY, INC. 510(k) NO: K990219(TRADITIONAL) ATTN: ANDREW KIMMEL PHONE NO : 714-361-1200 981 CALLE AMANECER SE DECISION MADE: 24-FEB-99 SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APF POROUS COATED LINE EXTENSION BIOMET, INC. 510(k) NO: K984154(TRADITIONAL) ATTN: FRED MCCLURE PHONE NO : 219-267-6639 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 11-FEB-99 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS S BIOMET, INC. 510(k) NO: K984209(TRADITIONAL) ATTN: DALENE HUFZIGER BINKLEY PHONE NO : 219-372-1612 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 03-FEB-99 WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LATERALIZED INTERGRAL POROUS PRIMARY FEMORAL COMPONENT BIOMET, INC. 510(k) NO: K984296(TRADITIONAL) ATTN: DARLENE HUFZIGER BINKLEY PHONE NO : 219-267-6639 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 18-FEB-99 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: 130 MODIFIED INTEGRAL FEMORAL COMPONENT BIOMET, INC. 510(k) NO: K984408(TRADITIONAL) ATTN: PATRICIA SANDBORN BERES PHONE NO : 219-297-6639 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 12-FEB-99 WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODULAR PROTUSIO CUP BIOMET, INC. 510(k) NO: K990032(TRADITIONAL) ATTN: DALENE HUFZIGER BINKLEY PHONE NO : 219-372-1612 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 18-FEB-99 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR FIXATION SYSTEM BIONX IMPLANTS, INC. 510(k) NO: K982721(TRADITIONAL) ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 13TH STREET, N.W. SE DECISION MADE: 17-FEB-99 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTICOAT T4 EIA KIT BIOTECX LABORATORIES, INC. 510(k) NO: K982298(TRADITIONAL) ATTN: MOHAN MEHRA PHONE NO : 713-643-0606 6023 SOUTH LOOP EAST SE DECISION MADE: 03-FEB-99 HOUSTON, TX 77033 510(k) STATEMENT DEVICE: BIPORE BALLOON DILATATION CATHETER BIPORE, INC. 510(k) NO: K983650(TRADITIONAL) ATTN: DURMUS KOCH PHONE NO : 201-767-1993 31 INDUSTRIAL PKWY. SE DECISION MADE: 17-FEB-99 NORTHVALE, NJ 07647 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E-FAX SYSTEM BLAKBAG, LTD., DIVISION OF COHEREN510(k) NO: K982034(TRADITIONAL) ATTN: J. HARVEY KNAUSS PHONE NO : 713-723-8169 11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 19-FEB-99 HOUSTON, TX 77071-3404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCU-CHEK HQ SYSTEM BOEHRINGER MANNHEIM CORP. 510(k) NO: K983047(TRADITIONAL) ATTN: MIKE FLIS PHONE NO : 800-428-5074 9115 HAGUE RD. SE DECISION MADE: 05-FEB-99 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECYS IGE ASSAY BOEHRINGER MANNHEIM CORP. 510(k) NO: K984326(TRADITIONAL) ATTN: PRISCILLA A HAMILL PHONE NO : 317-576-3723 9115 HAGUE ROAD SE DECISION MADE: 08-FEB-99 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS IGE CALCHECK BOEHRINGER MANNHEIM CORP. 510(k) NO: K984419(TRADITIONAL) ATTN: PRISCILLA A HAMILL PHONE NO : 317-576-3723 9115 HAGUE RD. SE DECISION MADE: 02-FEB-99 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OASIS THROMBECTOMY CATHETER SYSTEM BOSTON SCIENTIFIC CORP. 510(k) NO: K982363(TRADITIONAL) ATTN: LAURA MONDANO PHONE NO : 508-650-8173 ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 23-FEB-99 NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANDELA GENTLELASE II DERMATOLOGICAL LASER CANDELA CORP. 510(k) NO: K984601(TRADITIONAL) ATTN: JAY CAPLAN PHONE NO : 508-358-7637 530 BOSTON POST RD. SE DECISION MADE: 04-FEB-99 WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION OF VENTURI VENTILATOR CARDIOPULMONARY CORP. 510(k) NO: K990429(SPECIAL) ATTN: JOHN LAVIOLA PHONE NO : 203-301-6212 200 CASCADE BLVD. SE DECISION MADE: 24-FEB-99 MILFORD, CT 06460 510(k) STATEMENT DEVICE: CARE TENS CARE REHAB, INC. 510(k) NO: K984025(TRADITIONAL) ATTN: CHRISTIAN HUNT PHONE NO : 703-448-9644 1124 DOMINION COURT SE DECISION MADE: 10-FEB-99 MCLEAN, VA 22102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARESIDE AMYLASE CARESIDE, INC. 510(k) NO: K990025(TRADITIONAL) ATTN: KENNETH B ASARCH PHONE NO : 310-338-6767 6100 BRISTOL PARKWAY SE DECISION MADE: 08-FEB-99 CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERITITE PROCESS INDICATOR ACCESSORIES CASE MEDICAL, INC. 510(k) NO: K982151(TRADITIONAL) ATTN: MARCIA FRIEZE PHONE NO : 201-313-1999 65 RAILROAD AVE. SE DECISION MADE: 09-FEB-99 RIDGEFIELD, NJ 07657-0402 510(k) STATEMENT DEVICE: CERALAS DIODE LASER SYSTEM (MODEL H) CERAMOPTEC, INC. 510(k) NO: K983950(TRADITIONAL) ATTN: JOHNATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH STREET, NW SE DECISION MADE: 03-FEB-99 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VECTRA COMBO CHATTANOOGA GROUP, INC. 510(k) NO: K982317(TRADITIONAL) ATTN: CHERYL G DYER PHONE NO : 423-870-2281 4717 ADAMS RD. SE DECISION MADE: 01-FEB-99 CHATTANOOGA, TN 37343 510(k) STATEMENT DEVICE: VECTRA STIM MODELS 200 AND 400 CHATTANOOGA GROUP, INC. 510(k) NO: K982321(TRADITIONAL) ATTN: CHERYL G DYER PHONE NO : 423-870-2281 4717 ADAMS RD. SE DECISION MADE: 01-FEB-99 CHATTANOOGA, TN 37343 510(k) STATEMENT DEVICE: VECTRA PRO MODELS 2 AND 4 CHATTANOOGA GROUP, INC. 510(k) NO: K982324(TRADITIONAL) ATTN: CHERYL G DYER PHONE NO : 423-870-2281 4717 ADAMS RD. SE DECISION MADE: 01-FEB-99 CHATTANOOGA, TN 37343 510(k) STATEMENT DEVICE: PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY CHEMBIO DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K981913(TRADITIONAL) ATTN: RAYMOND DATTWYLER PHONE NO : 516-444-2348 25 EAST LOOP ROAD SE DECISION MADE: 12-FEB-99 STONEYBROOK, NY 11790 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IS ANTI-TPO IGG ELISA TEST SYSTEM COLUMBIA BIOSCIENCE, INC. 510(k) NO: K984228(TRADITIONAL) ATTN: NORMAN JENKINS PHONE NO : 410-995-0450 8775 M CENTRE PARK DR. SE DECISION MADE: 02-FEB-99 #559 510(k) SUMMARY AVAILABLE FROM FDA COLUMBIA, MD 21045 DEVICE: MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND: YAG L CONTINUUM BIOMEDICAL, MEDICAL DIV.510(k) NO: K983054(TRADITIONAL) ATTN: LAURIE A RIDENER PHONE NO : 925-828-3210 6533 SIERRA LANE SE DECISION MADE: 10-FEB-99 DUBLIN, CA 94568 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSMYOMETRIAL EMBRYO TRANSFER SET COOK OB/GYN 510(k) NO: K983595(TRADITIONAL) ATTN: BRENDA DAVIS PHONE NO : 812-829-6500 1100 W. MORGAN STREET SE DECISION MADE: 08-FEB-99 SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES COOK OB/GYN 510(k) NO: K983596(TRADITIONAL) ATTN: DEBBIE SCHMITT PHONE NO : 812-829-6500 1100 W. MORGAN STREET SE DECISION MADE: 05-FEB-99 SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOK MINI-INCUBATOR COOK OB/GYN 510(k) NO: K983642(TRADITIONAL) ATTN: BRENDA DAVIS PHONE NO : 812-829-6500 1100 W. MORGAN STREET SE DECISION MADE: 01-FEB-99 SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AN COOK, INC. 510(k) NO: K982333(TRADITIONAL) ATTN: APRIL LAVENDER PHONE NO : 800-346-2686 925 SOUTH CURRY PIKE SE DECISION MADE: 12-FEB-99 P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA BLOOMINGTON, IN 47402 DEVICE: 7F HYDROLYSER THROMBECTOMY CATHETER CORDIS CORPORATION 510(k) NO: K983534(TRADITIONAL) ATTN: ARIEL MACTAVISH PHONE NO : 305-824-2332 14201 N.W. 60TH AVE. SE DECISION MADE: 26-FEB-99 MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE (LPGD) CORPAK MEDSYSTEMS 510(k) NO: K990127(SPECIAL) ATTN: STEPHANIE WASIELEWSKI PHONE NO : 847-537-4061 100 CHADDICK DRIVE SE DECISION MADE: 10-FEB-99 WHEELING, IL 60090 510(k) STATEMENT DEVICE: NITRILE POWDER FREE EXAMINATION GLOVES CRANBERRY (M) SDN. BHD. 510(k) NO: K983334(TRADITIONAL) ATTN: CHONG YOON TAT PHONE NO : 055 451 055/546105 LOT 85, JALAN PORTLAND SE DECISION MADE: 19-FEB-99 TASEK INDUSTRIAL ESTATE 510(k) STATEMENT 31400 IPOH, PERAK, MALAYSIA DEVICE: CROSSTEX NON-WOVEN SPONGES CROSSTEX INTERNATIONAL 510(k) NO: K984187(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 55 NORTHERN BLVD., SUITE 410 SE DECISION MADE: 18-FEB-99 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION DRUG CALIBRATOR II, MODEL DC49B DADE BEHRING, INC. 510(k) NO: K990255(TRADITIONAL) ATTN: CATHY P CRAFT PHONE NO : 302-631-6280 BLDG. 500 MAIL BOX 514 SE DECISION MADE: 16-FEB-99 P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: ENIGMA DENTURE TEETH DAVIS SCHOTTLANDER & DAVIS, LTD. 510(k) NO: K984128(TRADITIONAL) ATTN: CLYDE E INGERSOLL PHONE NO : 716-693-6591 54 RIVERVIEW AVE SE DECISION MADE: 09-FEB-99 TONAWANDA, NY 14150-5260 510(k) STATEMENT DEVICE: NATURA DENTURE TEETH DAVIS SCHOTTLANDER & DAVIS, LTD. 510(k) NO: K984134(TRADITIONAL) ATTN: CYDE E INGERSOLL PHONE NO : 716-693-6591 54 RIVERVIEW AVE SE DECISION MADE: 12-FEB-99 TONAWANDA, NY 14150-5260 510(k) STATEMENT DEVICE: HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, DAVOL, INC., SUB. C.R. BARD, INC. 510(k) NO: K982867(TRADITIONAL) ATTN: ROBIN DRAGO PHONE NO : 401-463-7000 100 SOCKANOSSETT CROSSROAD SE DECISION MADE: 19-FEB-99 CRANSTON, RI 02920 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMNICORDER, MODEL 464 DEL MAR AVIONICS 510(k) NO: K990027(ABBREVIATED) ATTN: RAPHAEL HENKIN PHONE NO : 949-250-3200 1621 ALTON PARKWAY SE DECISION MADE: 09-FEB-99 IRVINE, CA 92714 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDART 455 SCANNER SYSTEM DEL MAR TECHNOLOGIES INC. 510(k) NO: K984339(TRADITIONAL) ATTN: JAN K ENEMAERK PHONE NO : 619-350-6066 11772 SORRENTO VALLEY RD. #237 SE DECISION MADE: 18-FEB-99 SAN DIEGO, CA 92121 510(k) STATEMENT DEVICE: 1ST IMPRESSION DEN-MAT CORP. 510(k) NO: K983106(TRADITIONAL) ATTN: W R GLACE PHONE NO : 805-922-8491 2727 SKYWAY DRIVE SE DECISION MADE: 09-FEB-99 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE DEPUY ACE MEDICAL CO. 510(k) NO: K990120(SPECIAL) ATTN: KATHLEEN DRAGOVICH PHONE NO : 310-414-6213 2260 EAST EL SEGUNDO BLVD. SE DECISION MADE: 01-FEB-99 EL SEGUNDO, CA 90245 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG DIAGNOSTIC PRODUCTS CORPORATION 510(k) NO: K990222(TRADITIONAL) ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200 5700 WEST 96TH STREET SE DECISION MADE: 26-FEB-99 LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IS EBV-EBNA-1 IGG ELISA TEST SYSTEM DIAMEDIX CORP. 510(k) NO: K981829(TRADITIONAL) ATTN: NORMAN JENKINS PHONE NO : 410-995-0450 8775 M CENTRE PARK DRIVE SE DECISION MADE: 16-FEB-99 #559 510(k) SUMMARY AVAILABLE FROM FDA COLUMBIA, MD 21045 DEVICE: IS EBV-EA-D IGG ELISA TEST SYSTEM DIAMEDIX CORP. 510(k) NO: K981831(TRADITIONAL) ATTN: NORMAN JENKINS PHONE NO : 410-995-0450 8775 M CENTRE PARK DRIVE SE DECISION MADE: 16-FEB-99 #559 510(k) SUMMARY AVAILABLE FROM FDA COLUMBIA, MD 21045 DEVICE: DIOSCAN DIOMED, INC. 510(k) NO: K990014(TRADITIONAL) ATTN: MAUREEN O'CONNELL PHONE NO : 954-349-6909 30-31 UNION WHARF, 3RD FLR. SE DECISION MADE: 26-FEB-99 BOSTON, MA 02109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM DISETRONIC MEDICAL SYSTEMS 510(k) NO: K990259(SPECIAL) ATTN: LEE LEICHTER PHONE NO : 941-768-1118 7690 CAMERON CIRCLE SE DECISION MADE: 12-FEB-99 FT. MEYERS, FL 33912 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAX IT DOREA, INC. 510(k) NO: K983438(TRADITIONAL) ATTN: RICHARD V MOSES,JR. PHONE NO : 912-377-1185 19 4TH AVENUE, S.E. SE DECISION MADE: 08-FEB-99 CAIRO, GA 31728 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DORNIER MEDILAS R DORNIER 510(k) NO: K984349(TRADITIONAL) ATTN: CAROL WERNECKE PHONE NO : 770-426-1315 1155 ROBERTS BOULEVARD SE DECISION MADE: 04-FEB-99 KENNESAW, GA 30144 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DS30 HCY HOMOCYSTEINE ASSAY KIT DREW SCIENTIFIC LTD. 510(k) NO: K982003(TRADITIONAL) ATTN: ANDREW KENNEY PHONE NO : 012 229 432089 PARK RD., TELEMETER BLDG. SE DECISION MADE: 11-FEB-99 BARROW IN FURNESS, UNITED KINGDOM 510(k) STATEMENT DEVICE: DISPOSABLE ELECTROSURGERY GROUNDING PAD E & M ENGINEERING, INC. 510(k) NO: K984276(TRADITIONAL) ATTN: ROGER STRUBE PHONE NO : 804-353-7160 1705 DABNEY RD. SE DECISION MADE: 10-FEB-99 RICHMOND, VA 23230 510(k) STATEMENT DEVICE: EDI VERIS SYSTEM ELECTRO-DIAGNOSTIC IMAGING, INC 510(k) NO: K983983(TRADITIONAL) ATTN: SHEILA W PICKERING PHONE NO : 650-969-6114 2081 LONGDEN CIRCLE SE DECISION MADE: 03-FEB-99 LOS ALTOS, CA 94024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA EMBOL-X, INC. 510(k) NO: K980631(TRADITIONAL) ATTN: JEAN CHANG PHONE NO : 650-390-0280 645 CLYDE AVENUE SE DECISION MADE: 02-FEB-99 MOUNTAIN VIEW, CA 94043-2208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STIMULAN- CALCIUM SULFATE BONE VOID FILLER ENCORE ORTHOPEDICS 510(k) NO: K982663(TRADITIONAL) ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-834-6237 9800 METRIC BOULEVARD SE DECISION MADE: 26-FEB-99 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXPOSURE RETRACTOR ENDIUS INC. 510(k) NO: K983144(TRADITIONAL) ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 24-FEB-99 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZY ENTERIC PRODUCTS, INC. 510(k) NO: K984544(TRADITIONAL) ATTN: JEFFREY PEACOCK PHONE NO : 800-233-8583 25 EAST LOOP DRIVE SE DECISION MADE: 18-FEB-99 STONY BROOK, NY 11790 510(k) STATEMENT DEVICE: ERCO-VAC -C ERCONS, INC. 510(k) NO: K990006(TRADITIONAL) ATTN: YAKOV ALTSHULER PHONE NO : 212-927-3275 66 OVERLOOK TERRACE, SUITE 2E SE DECISION MADE: 24-FEB-99 NEW YORK, NY 10040 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ERCO-RIBBON -C ERCONS, INC. 510(k) NO: K990008(TRADITIONAL) ATTN: YAKOV ALTSHULER PHONE NO : 212-927-3275 66 OVERLOOK TERRACE, SUITE 2E SE DECISION MADE: 24-FEB-99 NEW YORK, NY 10040 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIODE LASER ESC MEDICAL SYSTEMS LTD. 510(k) NO: K982119(TRADITIONAL) ATTN: ZVI LADIN PHONE NO : 011 972 49599000 YOKNEAM INDUSTRIAL PARK SE DECISION MADE: 04-FEB-99 P.O. BOX 240 510(k) SUMMARY AVAILABLE FROM FDA YOKNEAM, ISRAEL 20692 DEVICE: ELIPAR TRILIGHT ESPE DENTAL AG 510(k) NO: K984247(TRADITIONAL) ATTN: ANDREAS PETERMANN PHONE NO : 49 815 2700395 ESPE PLATZ SE DECISION MADE: 25-FEB-99 SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOPATH ULTRA VERESS NEEDLE ETHICON ENDO-SURGERY, INC. 510(k) NO: K983925(TRADITIONAL) ATTN: EDWIN O BILLIPS PHONE NO : 513-786-7162 4545 CREEK RD. SE DECISION MADE: 03-FEB-99 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORB ETHICON, INC. 510(k) NO: K984220(TRADITIONAL) ATTN: GREGORY R JONES PHONE NO : 908-218-2481 ROUTE 22 WEST SE DECISION MADE: 23-FEB-99 SOMERVILLE, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EWC: ECG II CABLE LEADWIRE SYSTEM EWC 510(k) NO: K984263(ABBREVIATED) ATTN: TIM DAVIS PHONE NO : 800-786-3707 N26W23315 PAUL ROAD SE DECISION MADE: 02-FEB-99 PEWAUKEE, WI 53072-4061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM EXACTECH, INC. 510(k) NO: K990197(SPECIAL) ATTN: GARY J MILLER PHONE NO : 352-377-1140 2320 N.W. 66TH CT. SE DECISION MADE: 04-FEB-99 GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM FIBRA SONICS, INC. 510(k) NO: K984143(TRADITIONAL) ATTN: ROBERT BROHM PHONE NO : 773-286-7377 5312 NORTH ELSTON AVE. SE DECISION MADE: 16-FEB-99 CHICAGO, IL 60630 510(k) STATEMENT DEVICE: EXONIX FIBRA SONICS, INC. 510(k) NO: K984199(TRADITIONAL) ATTN: ROBERT BROHM PHONE NO : 773-286-7377 5312 NORTH ELSTON AVE. SE DECISION MADE: 17-FEB-99 CHICAGO, IL 60630 510(k) STATEMENT DEVICE: MODIFICATION OF BIONECT HYDROGEL GAUZE PADS FIDIA PHARMACEUTICAL CORP. 510(k) NO: K984262(TRADITIONAL) ATTN: ROBERTO FIORENTINI PHONE NO : 202-371-1325 2000 K STREET,N.W SE DECISION MADE: 10-FEB-99 SUITE 700 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20006 DEVICE: MODIFICATION OF BIONECT CLEAR HYDROGEL FIDIA PHARMACEUTICAL CORP. 510(k) NO: K984264(TRADITIONAL) ATTN: ROBERTO FIORENTINI PHONE NO : 202-371-1325 2000 K STREET,N.W SE DECISION MADE: 10-FEB-99 SUITE 700 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20006 DEVICE: MODIFICATION OF BIONECT HYDROGEL SPRAY FIDIA PHARMACEUTICAL CORP. 510(k) NO: K984266(TRADITIONAL) ATTN: ROBERTO FIORENTINI PHONE NO : 202-371-1325 2000 K STREET,N.W SE DECISION MADE: 10-FEB-99 SUITE 700 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20006 DEVICE: MODIFICATION OF BIONECT HYDROGEL FOAM FIDIA PHARMACEUTICAL CORP. 510(k) NO: K984267(TRADITIONAL) ATTN: ROBERTO FIORENTINI PHONE NO : 202-371-1325 2000 K STREET,N.W SE DECISION MADE: 10-FEB-99 SUITE 700 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20006 DEVICE: BIONECT HYDROGEL FIDIA PHARMACEUTICAL CORP. 510(k) NO: K984413(TRADITIONAL) ATTN: ROBERTO FIORENTINI PHONE NO : 202-371-1325 2000 K STREET,N.W SE DECISION MADE: 10-FEB-99 SUITE 700 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20006 DEVICE: C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, AT FRESENIUS HEMOTECHNOLOGY, INC. 510(k) NO: K984233(TRADITIONAL) ATTN: VIRGINIA R SINGER PHONE NO : 925-688-0990 110 MASON CIRCLE SUITE A SE DECISION MADE: 01-FEB-99 CONCORD, CA 94520-1238 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM FRIDDLE'S ORTHOPEDIC APPLIANCES, I510(k) NO: K980689(TRADITIONAL) ATTN: PHONE NO : 12306 BELTON HONEA PATH HWY. SE DECISION MADE: 18-FEB-99 HONEA PATH, SC 29654 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GUIDEWIRE GALT MEDICAL CORP. 510(k) NO: K982559(TRADITIONAL) ATTN: JIM EDINGS PHONE NO : 972-271-5177 2475 MERRITT DR. SE DECISION MADE: 01-FEB-99 GARLAND, TX 75041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), GAMBRO HEALTHCARE 510(k) NO: K980386(TRADITIONAL) ATTN: JEFFREY R SHIDEMAN PHONE NO : 612-835-4018 1185 OAK ST. SE DECISION MADE: 24-FEB-99 LAKEWOOD, CO 80215-4498 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GC UNIFAST TRAD GC AMERICA, INC. 510(k) NO: K984365(TRADITIONAL) ATTN: TERRY L JORITZ PHONE NO : 708-597-0900 3737 WEST 127TH STREET SE DECISION MADE: 25-FEB-99 ALSIP, IL 60803 510(k) STATEMENT DEVICE: MIRACLE MIX POWDER/LIQUID GC AMERICA, INC. 510(k) NO: K984505(TRADITIONAL) ATTN: TERRY L JORITZ PHONE NO : 708-597-0900 3737 WEST 127TH STREET SE DECISION MADE: 04-FEB-99 ALSIP, IL 60803 510(k) STATEMENT DEVICE: GE LOGIQ700 DIAGNOSTIC ULTRASOUND SYSTEM WITH B-FLOW GE MEDICAL SYSTEMS, INC. 510(k) NO: K990226(TRADITIONAL) ATTN: ALLEN SCHUH PHONE NO : 414-647-4385 P.O. BOX 414 SE DECISION MADE: 09-FEB-99 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIGNA 1.5T PHOSPHORUS (P) TRANSMIT/RECEIVE FLEX COIL GENERAL ELECTRIC MEDICAL SYSTEM 510(k) NO: K983139(TRADITIONAL) ATTN: LARRY A KROGER PHONE NO : 414-544-3894 3200 N. GRANDVIEW BLVD. SE DECISION MADE: 19-FEB-99 WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLIADIN ANTIBODIES ELISA GENESIS DIAGNOSTICS LTD. 510(k) NO: K973910(TRADITIONAL) ATTN: MICHAEL WALKER PHONE NO : 013 538 62220 EDEN RESEARCH PARK SE DECISION MADE: 17-FEB-99 HENRY CRABB ROAD 510(k) STATEMENT LITTLEPORT, CAMBRIDGESHIRE, UNITED KINGDOM CB6 1SE DEVICE: GENICON TROCAR GENICON 510(k) NO: K982472(TRADITIONAL) ATTN: GARY W HABERLAND PHONE NO : 407-273-7619 573 WATERSCAPE WAY SE DECISION MADE: 04-FEB-99 ORLANDO, FL 32808 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR GEREONICS, INC. 510(k) NO: K983449(TRADITIONAL) ATTN: GERALD A ROST PHONE NO : 760-731-9003 4650-143 DULIN ROAD SE DECISION MADE: 08-FEB-99 FALLBROOK, CA 92028 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HSV 1+2 IGG ELISA TEST GULL LABORATORIES, INC. 510(k) NO: K983541(TRADITIONAL) ATTN: FRED W RACHFORD PHONE NO : 801-263-3524 1011 MURRAY HOLLADAY RD. SE DECISION MADE: 26-FEB-99 SALT LAKE CITY, UT 84117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GUTHRIE PRIME POWDER-FREE GUTHRIE MEDICARE PRODUCTS (NS) SDN510(k) NO: K990228(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 19-FEB-99 GREAT NECK, NY 11021 510(k) STATEMENT DEVICE: AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL HAND BIOMECHANICS LAB, INC. 510(k) NO: K984442(TRADITIONAL) ATTN: TIMOTHY STALLINGS PHONE NO : 916-923-5073 77 SCRIPPS DR., SUITE 104 SE DECISION MADE: 12-FEB-99 SACRAMENTO, CA 95825 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESIN 4 HARRY J. BOSWORTH CO. 510(k) NO: K981862(TRADITIONAL) ATTN: MILDRED M GOLDSTEIN PHONE NO : 847-679-3400 7227 NORTH HAMLIN AVE. SE DECISION MADE: 09-FEB-99 SKOKIE, IL 60076 510(k) STATEMENT DEVICE: HARWILL MEDICAL U-KLIP UMBILICAL CLAMP HARWILL MEDICAL (PTY) LTD. 510(k) NO: K983204(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 410-451-0639 P O BOX 4341 SE DECISION MADE: 26-FEB-99 CROFTON, MD 21114 510(k) STATEMENT DEVICE: GLUMA ONE BOND HERAEUS KULZER, INC. 510(k) NO: K990143(TRADITIONAL) ATTN: CHERYL V ZIMMERMAN PHONE NO : 219-299-6662 4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 25-FEB-99 SOUTH BEND, IN 46614-2517 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONOS 5500 IMAGING SYSTEM M2424A VERSION B.O HEWLETT-PACKARD CO. 510(k) NO: K990339(TRADITIONAL) ATTN: ANN FAY MICHAELS PHONE NO : 978-659-2980 3000 MINUTEMAN RD. SE DECISION MADE: 18-FEB-99 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LINEAR ARRAY TRANSDUCER,MODEL HP 21376, M2410A ULTRASOUND IMAGI HEWLETT-PACKARD CO. 510(k) NO: K990400(TRADITIONAL) ATTN: STEPHEN B SINGLAR PHONE NO : 978-659-2101 3000 MINUTEMAN RD. SE DECISION MADE: 24-FEB-99 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K984280(TRADITIONAL) ATTN: JAMES JOCHEN ROGERS PHONE NO : 800-800-3106 1959 SUMMIT COMMERCE PARK SE DECISION MADE: 08-FEB-99 TWINSBURG, OH 44087-2371 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOWMEDICA HUMERAL INTERCALARY SYSTEM HOWMEDICA INC. 510(k) NO: K984202(TRADITIONAL) ATTN: FRANK MAAS PHONE NO : 201-507-7875 359 VETERANS BOULEVARD SE DECISION MADE: 05-FEB-99 RUTHERFORD, NJ 07070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XIA SPINE SYSTEM HOWMEDICA INC. 510(k) NO: K984251(TRADITIONAL) ATTN: VIVIAN KELLY PHONE NO : 201-507-7830 359 VETERANS BOULEVARD SE DECISION MADE: 24-FEB-99 RUTHERFORD, NJ 07070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZETA MULTIZONE LOCKING NAIL SYSTEM HOWMEDICA INC. 510(k) NO: K984305(TRADITIONAL) ATTN: JOSEPH VOLPE PHONE NO : 201-507-6695 359 VETERANS BOULEVARD SE DECISION MADE: 01-FEB-99 RUTHERFORD, NJ 07070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DALL-MILES CABLE GRIP (A-GRIP) HOWMEDICA OSTEONICS 510(k) NO: K984432(TRADITIONAL) ATTN: FRANK MAAS PHONE NO : 201-507-7875 359 VETERANS BOULEVARD SE DECISION MADE: 24-FEB-99 RUTHERFORD, NJ 07070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACTITORIC (OCUFILCON A) SOFT (HYDROPHILIC) TORIC CONTACT LENS FO HYDRON LIMITED 510(k) NO: K983160(TRADITIONAL) ATTN: JULIAN B HOLLOWAY PHONE NO : 011 441 252554500 HAWLEY LANE SE DECISION MADE: 18-FEB-99 FARNBOROUGH, HANTS, UNITED KINGDOM510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARAGON BASAL/BOLUS ADMINISTRATION SET I-FLOW CORP. 510(k) NO: K984063(TRADITIONAL) ATTN: ROBERT J BARD PHONE NO : 949-206-2700 20202 WINDROW DR. SE DECISION MADE: 09-FEB-99 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARAGON INFUSION I-FLOW CORP. 510(k) NO: K984146(TRADITIONAL) ATTN: ROBERT J BARD PHONE NO : 949-206-2700 20202 WINDROW DR. SE DECISION MADE: 09-FEB-99 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KVO CHECK VALVE ACCESSORY, MODEL EV-0001 I-FLOW CORP. 510(k) NO: K984441(TRADITIONAL) ATTN: SHANE P NOEHRE PHONE NO : 949-206-2700 20202 WINDROW DR. SE DECISION MADE: 22-FEB-99 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARAGON BOLUS ACCESSORY SET I-FLOW CORP. 510(k) NO: K984638(TRADITIONAL) ATTN: ROBERT J BARD PHONE NO : 949-206-2700 20202 WINDROW DR. SE DECISION MADE: 09-FEB-99 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS IGEL VISION CARE PTE LTD 510(k) NO: K984523(TRADITIONAL) ATTN: JOHN M SZABOCSIK PHONE NO : 312-553-0828 203 N. WABASH, STE 1200 SE DECISION MADE: 16-FEB-99 CHICAGO,, IL 60601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRAJECTORY GUIDE, MODEL # TGX-XXX IMAGE-GUIDED NEUROLOGICS, INC. 510(k) NO: K983539(TRADITIONAL) ATTN: MICHAEL J RENNER PHONE NO : 651-702-1095 570 HALE AVENUE NORTH SE DECISION MADE: 12-FEB-99 OAKDALE, MN 55128 510(k) STATEMENT DEVICE: IMPLEX SCREW AND WASHER SYSTEM IMPLEX CORP. 510(k) NO: K982751(TRADITIONAL) ATTN: ROBERT POGGIE PHONE NO : 201-818-1800 80 COMMERCE DR. SE DECISION MADE: 01-FEB-99 ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONTINUUM KNEE SYSTEM COBALT CHROMIUM ALLOY TIBIAL COMPONENT IMPLEX CORP. 510(k) NO: K984291(TRADITIONAL) ATTN: JOHN SCHALAGO PHONE NO : 201-818-1800 80 COMMERCE DR. SE DECISION MADE: 01-FEB-99 ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRAIGHT-IN-ORTHOPEDIC BONE SCREW FIXATION SYSTEM INFLUENCE, INC. 510(k) NO: K990095(TRADITIONAL) ATTN: PETER BICK PHONE NO : 415-546-7700 555 THIRTEENTH STREET, N.W. SE DECISION MADE: 01-FEB-99 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROTAC-BONE ANCHOR SYSTEM INFLUENCE, INC. 510(k) NO: K990160(SPECIAL) ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH STREET, N.W. SE DECISION MADE: 16-FEB-99 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INNOVA TELESCOPIC DISTRACTOR INNOVA CORP. 510(k) NO: K984117(TRADITIONAL) ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813 C/O HOGAN & HARTSON SE DECISION MADE: 10-FEB-99 555 THIRTEENTH STREET, N.W. 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20004 DEVICE: TEL-ECHO SYSTEM INNOVATIVE MEDICAL SOLUTIONS 510(k) NO: K990052(TRADITIONAL) ATTN: LAWRENCE E SIEB,JR PHONE NO : 414-569-5716 1250 NEWPORT DRIVE SE DECISION MADE: 19-FEB-99 OCONOMOWOC, WI 53066 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTA LITE GBM ELISA INOVA DIAGNOSTICS, INC. 510(k) NO: K984336(TRADITIONAL) ATTN: BRYS C MYERS PHONE NO : 619-586-9900 10180 SCRIPPS RANCH BLVD. SE DECISION MADE: 08-FEB-99 SAN DIEGO, CA 92131 510(k) STATEMENT DEVICE: QUANTEX ASO-CRP-RP CONTROL II INSTRUMENTATION LABORATORIES, INC.510(k) NO: K984437(TRADITIONAL) ATTN: CAROL MARBLE PHONE NO : 781-861-4467 113 HARTWELL AVENUE SE DECISION MADE: 02-FEB-99 LEXINGTON, MA 02173-3190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIPERSOFT INTEGRA MEDICAL 510(k) NO: K984030(TRADITIONAL) ATTN: W. EDWARD JOHANSEN PHONE NO : 310-826-4902 11661 SAN VICENTE BLVD. SE DECISION MADE: 10-FEB-99 LOS ANGELES, CA 90049 510(k) STATEMENT DEVICE: MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHE INTERVASCULAR, INC. 510(k) NO: K984294(TRADITIONAL) ATTN: JAMES S MILLER PHONE NO : 727-539-0833 16331 BAY VISTA DRIVE SE DECISION MADE: 22-FEB-99 CLEARWATER, FL 34620 510(k) STATEMENT DEVICE: ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000 INTRACOM CORPORATION 510(k) NO: K984405(TRADITIONAL) ATTN: JAMES A NATIONS PHONE NO : 408-569-3860 1309 S. MARY AVENUE SE DECISION MADE: 08-FEB-99 SUNNYVALE, CA 94087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL TOP END TERMINATOR SS MANUAL WHEELCHAIR INVACARE CORP. 510(k) NO: K990157(TRADITIONAL) ATTN: EDWARD A KROLL PHONE NO : 440-329-6595 ONE INVACARE WAY SE DECISION MADE: 03-FEB-99 ELYRIA, OH 44035-2125 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLASTOCYST MEDIUM IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K983580(TRADITIONAL) ATTN: ROBERTA L JOHNSON PHONE NO : 800-437-5706 2511 DAIMLER ST. SE DECISION MADE: 18-FEB-99 SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HUMAN SERUM ALBUMIN (HSA) IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K983584(TRADITIONAL) ATTN: ROBERTA L JOHNSON PHONE NO : 800-437-5706 2511 DAIMLER ST. SE DECISION MADE: 08-FEB-99 SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HTF MEDIUM, MODIFIED HTF MEDIUM- HEPES, HTF POWDER (WITHOUT ANTI IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K983586(TRADITIONAL) ATTN: ROBERTA L JOHNSON PHONE NO : 800-437-5706 2511 DAIMLER ST. SE DECISION MADE: 18-FEB-99 SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: P-1 (PREIMPLANTATION STAGE ONE) MEDIUM IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K983589(TRADITIONAL) ATTN: ROBERTA L JOHNSON PHONE NO : 800-437-5706 2511 DAIMLER ST. SE DECISION MADE: 18-FEB-99 SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: D-SIGN III (R&D PROJECT DW264#7) IVOCLAR NORTH AMERICA, INC. 510(k) NO: K990077(TRADITIONAL) ATTN: PETER P MANCUSO PHONE NO : 716-691-0010 175 PINEVIEW DR. SE DECISION MADE: 12-FEB-99 AMHERST, NY 14228 510(k) STATEMENT DEVICE: D-SIGN IV (R&D PROJECT DW265#37) IVOCLAR NORTH AMERICA, INC. 510(k) NO: K990078(TRADITIONAL) ATTN: PETER P MANCUSO PHONE NO : 716-691-0010 175 PINEVIEW DR. SE DECISION MADE: 12-FEB-99 AMHERST, NY 14228 510(k) STATEMENT DEVICE: KSEA HF-SNARE KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K983901(TRADITIONAL) ATTN: KEVIN KENNAN PHONE NO : 310-410-2769 600 CORPORATE POINTE SE DECISION MADE: 01-FEB-99 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYDRO-CAST VERSA-TEMP NON-EUGENOL PROVISIONAL CEMENT, MODEL 7001 KAY SEE DENTAL MFG. CO. 510(k) NO: K990155(TRADITIONAL) ATTN: CLARK SMITH PHONE NO : 816-842-2817 124 EAST MISSOURI AVE. SE DECISION MADE: 25-FEB-99 KANSAS CITY, MO 64106-1294 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED LATEX EXAMINATION GLOVES, NON-STERILE KILANG BARANGAN GETAH DIOH 510(k) NO: K984125(TRADITIONAL) ATTN: NORLI MANAFF PHONE NO : 06 481 6145 LOT 9, KAWASAN PERINDUSTRIAN SE DECISION MADE: 09-FEB-99 DIOH, KUALA PILAH 510(k) STATEMENT NEGERI SEMBILAN, MALAYSIA 72000 DEVICE: KMI WRIST FUSION SYSTEM KINETIKOS MEDICAL, INC. 510(k) NO: K990094(TRADITIONAL) ATTN: MICHAEL COLLINS PHONE NO : 619-558-2233 4115 SORRENTO VALLEY BLVD. SE DECISION MADE: 18-FEB-99 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARFIL SE BOND KURARAY COMPANY 510(k) NO: K990040(TRADITIONAL) ATTN: KOJI FUJITA PHONE NO : 212-986-2230 200 PARK AVE. SE DECISION MADE: 04-FEB-99 NEW YORK, NY 10166 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAGLOVE BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FRE LAGLOVE (M) SDN. BHD. 510(k) NO: K990268(TRADITIONAL) ATTN: G. BASKARAN PHONE NO : 603 833 5411 LOT 478, JALAN SIMPANG BALAK, SE DECISION MADE: 24-FEB-99 OFF BATU 13, JALAN CHERAS 510(k) STATEMENT KAJANG, SELANGOR, D.E., MALAYSIA 43000 DEVICE: LAGLOVE BRAND LATEX EXAMINATION GLOVE (POWDER FREE) LAGLOVE (M) SDN. BHD. 510(k) NO: K990270(TRADITIONAL) ATTN: G. BASKARAN PHONE NO : 603 833 5411 LOT 478, JALAN SIMPANG BALAK, SE DECISION MADE: 18-FEB-99 OFF BATU 13, JALAN CHERAS 510(k) STATEMENT KAJANG, SELANGOR, D.E., MALAYSIA 43000 DEVICE: LAGLOVE BRAND LATEX EXAMINATION GLOVES (LOW PROTEIN) LAGLOVE (M) SDN. BHD. 510(k) NO: K990285(TRADITIONAL) ATTN: G BASKARAN PHONE NO : 603 833 5411 LOT 478, JALAN SIMPANG BALAK, SE DECISION MADE: 18-FEB-99 OFF BATU 13, JALAN CHERAS 510(k) STATEMENT KAJANG, SELANGOR, D.E., MALAYSIA 43000 DEVICE: SMOOTHLASE ALEXANDRITE LASER SYSTEM LEISEGANG MEDICAL, INC. 510(k) NO: K990043(TRADITIONAL) ATTN: LORNA K LINVILLE PHONE NO : 727-544-2322 6401 CONGRESS AVE. SE DECISION MADE: 11-FEB-99 BOCA RATON, FL 33487-2883 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADEC DENTAL UNIT, MODELS CENTURY PLUS & CASCADE, DCI DENTAL UNIT LITE SPECIALTY METAL WORKS, INC. 510(k) NO: K984609(TRADITIONAL) ATTN: DAVID R COLE PHONE NO : 503-592-9235 20460 SW AVERY COURT SE DECISION MADE: 09-FEB-99 TUALATIN, OR 97062 510(k) STATEMENT DEVICE: LOBOB UNIVERSAL CONTACT LENS CLEANER LOBOB LABORATORIES, INC. 510(k) NO: K990044(TRADITIONAL) ATTN: DANIEL J MANELLI PHONE NO : 202-261-1000 2000 M STREET (#700) SE DECISION MADE: 11-FEB-99 WASHINGTON, DC 20036 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHEER GLYDE DAMS LOUISE C. MYERS 510(k) NO: K990067(TRADITIONAL) ATTN: LOUISE C MYERS PHONE NO : 425-867-0892 14808 N.E. 66TH STREET SE DECISION MADE: 19-FEB-99 REDMOND, WA 98052-4712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDCO ASPIRATOR IV MEDCO MANUFACTURING 510(k) NO: K982371(ABBREVIATED) ATTN: ELAINE MARTIN PHONE NO : 281-379-3100 8319 THORA #A1 SE DECISION MADE: 12-FEB-99 SPRING, TX 77379 510(k) STATEMENT DEVICE: BIRTCHER UV LAMP MEDFAXX, INC. 510(k) NO: K973865(TRADITIONAL) ATTN: BOB JOHNSON PHONE NO : 800-937-3993 P.O. BOX 17827 SE DECISION MADE: 26-FEB-99 RALEIGH, NC 27619-7827 510(k) STATEMENT DEVICE: PREPARE HOME INFUSION PUMP MEDICAL INFUSION TECHNOLOGIES, INC510(k) NO: K983634(TRADITIONAL) ATTN: THOMAS L PARKER PHONE NO : 716-667-3318 6576 EAST QUAKER ST. SE DECISION MADE: 24-FEB-99 ORCHARD PARK, NY 14127-2593 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLARICEL STERILIZATION POUCHES AND STERILIZATION REELS MEDICEL, S.A. DE C.V. 510(k) NO: K972719(TRADITIONAL) ATTN: T. WHIT ATHEY PHONE NO : 301-770-9590 12300 TWINBROOK PARKWAY SE DECISION MADE: 04-FEB-99 SUITE 625 510(k) STATEMENT ROCKVILLE, MD 20852 DEVICE: LITE-TOUCH SYRINGE MEDICORE 510(k) NO: K983430(TRADITIONAL) ATTN: BONNIE J KAPLAN PHONE NO : 800-327-8894 2647 WEST 81 ST. SE DECISION MADE: 09-FEB-99 HIALEAH, FL 33016 510(k) STATEMENT DEVICE: UP-GRADE MEDISIM LTD. 510(k) NO: K983887(TRADITIONAL) ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH ST, NW SE DECISION MADE: 12-FEB-99 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: (1) DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-250; (2) FULLY AUTO MEDITEC CO., LTD. 510(k) NO: K990380(TRADITIONAL) ATTN: PHONE NO : SE DECISION MADE: 22-FEB-99 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MEDTRONIC FUNCTIONAL DIAGNOSTICS A510(k) NO: K981733(TRADITIONAL) ATTN: ANN-CHRISTINE JONSSON PHONE NO : 011 454 4579000 16-18 TONSBAKKEN SE DECISION MADE: 04-FEB-99 SKOVLUNDE, DENMARK DK-2740 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRONIC MODEL 7495 EXTENSION KIT MEDTRONIC NEUROLOGICAL 510(k) NO: K990104(SPECIAL) ATTN: LISA L PRITCHARD PHONE NO : 612-514-5624 800 53RD AVE., N.E. SE DECISION MADE: 09-FEB-99 MINNEAPOLIS, MN 55421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM MEDTRONIC PS MEDICAL 510(k) NO: K984053(TRADITIONAL) ATTN: JEFFREY HENDERSON PHONE NO : 805-968-1546 125 CREMONA DR. SE DECISION MADE: 04-FEB-99 GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYS STIM 294, MODEL ME 294 METTLER ELECTRONICS CORP. 510(k) NO: K984114(TRADITIONAL) ATTN: ROBERT E FLEMING PHONE NO : 800-854-9305 1333 SOUTH CLAUDINA ST. SE DECISION MADE: 09-FEB-99 ANAHEIM, CA 92805 510(k) STATEMENT DEVICE: SONICATOR PLUS 992, MODEL NUMBER ME 992 AND SONICATOR PLUS 994, METTLER ELECTRONICS CORP. 510(k) NO: K984142(TRADITIONAL) ATTN: ROBERT E FLEMING PHONE NO : 800-854-9305 1333 SOUTH CLAUDINA ST. SE DECISION MADE: 09-FEB-99 ANAHEIM, CA 92805 510(k) STATEMENT DEVICE: FUSICRYL MICRO DENTAL LABORATORIES 510(k) NO: K984467(TRADITIONAL) ATTN: NICOLAS E AZAR PHONE NO : 925-556-2500 6665 AMADOR PLAZA RD., #200 SE DECISION MADE: 24-FEB-99 DUBLIN, CA 94568 510(k) STATEMENT DEVICE: MICROLIFE IT2CA1 MICROLIFE SYSTEMS AG 510(k) NO: K990168(ABBREVIATED) ATTN: SCOT J DUBE PHONE NO : 353-314-2599 1330 WEST CITIZENS BLVD., SE DECISION MADE: 25-FEB-99 SUITE 402-404 510(k) SUMMARY AVAILABLE FROM FDA LEESBURG, FL 34748 DEVICE: MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE MICROMEDICAL INDUSTRIES, LTD. 510(k) NO: K990266(SPECIAL) ATTN: DEAN E SYNDER PHONE NO : 847-446-8518 189 HAPP ROAD SE DECISION MADE: 02-FEB-99 NORTHFIELD, IL 60093 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAHO AUTOCLAVABLE LAPAROSCOPE MICROPTIX INT'L, LLC. 510(k) NO: K982276(TRADITIONAL) ATTN: GEORGE N HALLACK PHONE NO : 203-466-1256 310 MAIN ST. SE DECISION MADE: 18-FEB-99 EAST HAVEN, CT 06512 510(k) STATEMENT DEVICE: NORMLGEL 0.9% ISOTONIC SALINE GEL MOLNLYCKE HEALTH CARE 510(k) NO: K984368(TRADITIONAL) ATTN: MIGUEL A NEGRON PHONE NO : 610-499-3383 500 BALDWIN TOWER SE DECISION MADE: 22-FEB-99 EDDYSTONE, PA 19022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE MOSS TUBES, INC. 510(k) NO: K984310(TRADITIONAL) ATTN: HARRY A SCHLAKMAN PHONE NO : 908-355-6032 304 VERONA AVENUE SE DECISION MADE: 24-FEB-99 ELIZABETH, NJ 07208 510(k) STATEMENT DEVICE: SUBCUTANEOUS INFUSION SETS, MSR MODEL A & B MSR, INC. 510(k) NO: K984561(TRADITIONAL) ATTN: MARY MCNAMARA PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 04-FEB-99 NORTH ATTLEBORO, MA 02760-4153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUROVASX SUB-MICROINFUSION CATHETER NEUROVASX, INC. 510(k) NO: K984258(TRADITIONAL) ATTN: JEFFREY A LEE PHONE NO : 612-476-8106 2355 POLARIS LANE NO. SE DECISION MADE: 11-FEB-99 SUITE 116 510(k) SUMMARY AVAILABLE FROM FDA PLYMOUTH, MN 55447 DEVICE: NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY NICHOLS INSTITUTE DIAGNOSTICS 510(k) NO: K984186(TRADITIONAL) ATTN: JIMMY WONG PHONE NO : 949-240-5260 33608 ORTEGA HIGHWAY SE DECISION MADE: 02-FEB-99 SAN JUAN CAPISTRANO, CA 92690-6130510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL NICHOLS INSTITUTE DIAGNOSTICS 510(k) NO: K984520(TRADITIONAL) ATTN: JIM WONG PHONE NO : 949-240-5260 33051 CALLE AVIADOR SE DECISION MADE: 05-FEB-99 SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELK LASER FILM DIGITIZER NISHIMOTO SANGYO CO., LTD 510(k) NO: K984409(TRADITIONAL) ATTN: GARY J ALLSEBROOK PHONE NO : 510-276-2648 16303 PANORAMIC WAY SE DECISION MADE: 12-FEB-99 SAN LEANDRO, CA 94578-1116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NORIAN PERIODONTAL/DENTAL CEMENT (PDC) NORIAN CORP. 510(k) NO: K983104(TRADITIONAL) ATTN: KIM TOMPKINS PHONE NO : 408-252-6800 10260 BUBB ROAD SE DECISION MADE: 12-FEB-99 CUPERTINO, CA 95014-4166 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMNIFLATOR 7640 MODEL 7-640-00 NORTHGATE TECHNOLOGIES, INC. 510(k) NO: K983326(TRADITIONAL) ATTN: CASSEY KUREK PHONE NO : 847-608-8900 600 CHURCH RD. SE DECISION MADE: 05-FEB-99 ELGIN, IL 60123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TCM 3000 AND TCM ENDO NOUVAG AG 510(k) NO: K981679(TRADITIONAL) ATTN: MARGIT ESCHBAUMER PHONE NO : 083 419 15050 SUDETENSTR. 5 SE DECISION MADE: 09-FEB-99 KAUFBEUREN D87600, GERMANY D87600510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUMOBAG NUMOTECH, INC. 510(k) NO: K981949(TRADITIONAL) ATTN: W. PATRICK NOONAN PHONE NO : 818-887-5600 21800 OXNARD ST., SUITE 840 SE DECISION MADE: 03-FEB-99 WARNER CENTER PLAZA 510(k) STATEMENT WOODLAND HILLS, CA 91367 DEVICE: PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM NYCOMED AMERSHAM IMAGING 510(k) NO: K983314(TRADITIONAL) ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 19-FEB-99 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIPOLAR GRASPING FORCEPS BIQ+ OLYMPUS AMERICA, INC. 510(k) NO: K984417(TRADITIONAL) ATTN: LAURA STORMS-TYLER PHONE NO : 516-844-5688 TWO CORPORATE CENTER DR. SE DECISION MADE: 24-FEB-99 MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: B-400 CEILING MOUNTED POSSITIONER, MODEL B-400 OMEGA MEDICAL IMAGING, INC. 510(k) NO: K990055(TRADITIONAL) ATTN: DOUGLAS M COON PHONE NO : 407-323-9400 675 HICKMAN CIRCLE SE DECISION MADE: 02-FEB-99 SANFORD, FL 32771 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE FREMSTAD RING OPHTHALMIC SOLUTIONS, LLC 510(k) NO: K982599(TRADITIONAL) ATTN: DARIA A FREMSTAD PHONE NO : 770-939-9040 2179 NORTHLAKE PARKWAY SE DECISION MADE: 16-FEB-99 BUILDING 5, SUITE 115 510(k) SUMMARY AVAILABLE FROM FDA TUCKER, GA 30084 DEVICE: CORSAIRE OPTIWAY TECHNOLOGY, INC. 510(k) NO: K982750(ABBREVIATED) ATTN: FRANK W LAVALLEY PHONE NO : 202-672-5300 3000 K STREET N.W. SE DECISION MADE: 01-FEB-99 SUITE 500 510(k) STATEMENT WASHINGTON, DC 20007 DEVICE: PANORAMIC200 OPTHALMOSCOPE OPTOS PLC 510(k) NO: K983999(TRADITIONAL) ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813 555 THIRTEENTH STREET N.W. SE DECISION MADE: 03-FEB-99 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700 OPTOVENT, INCORPORATED 510(k) NO: K981725(TRADITIONAL) ATTN: CLAES RYMOND PHONE NO : 201-224-3688 1350 FIFTEENTH STREET SE DECISION MADE: 02-FEB-99 SUITE 4H 510(k) STATEMENT FORT LEE, NJ 07024 DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITROS ORTHO-CLINICAL DIAGNOSTICS 510(k) NO: K984166(TRADITIONAL) ATTN: ANNE ZAVERTNIK PHONE NO : 716-453-4402 100 INDIGO CREEK DRIVE SE DECISION MADE: 05-FEB-99 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMU ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K983690(TRADITIONAL) ATTN: ANNE ZAVERTNIK PHONE NO : 716-453-3790 100 INDIGO CREEK DR. SE DECISION MADE: 02-FEB-99 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYMER OBL SB ANCHOR / SUTURE COMBINATION ORTHOPAEDIC BIOSYSTEMS, LTD. 510(k) NO: K982996(TRADITIONAL) ATTN: JEFFRY B SKIBA PHONE NO : 602-596-4066 15990 N GREENWAY-HAYDEN LOOP SE DECISION MADE: 04-FEB-99 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA SCOTTSDALE, AZ 85260 DEVICE: OSTEO-MESH TM-300 OSTEOGENICS BIOMEDICAL, INC 510(k) NO: K984230(TRADITIONAL) ATTN: RICHARD A HAMER PHONE NO : 817-294-3644 6401 MEADOWS WEST DR SE DECISION MADE: 04-FEB-99 FORT WORTH, TX 76132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: J-SERIES OMEGA TOTAL HIP SYSTEM OSTEOIMPLANT TECHNOLOGY, INC. 510(k) NO: K990003(TRADITIONAL) ATTN: SAM SON PHONE NO : 410-785-0700 11201 PEPPER RD. SE DECISION MADE: 24-FEB-99 HUNT VALLEY, MD 21031-1201 510(k) STATEMENT DEVICE: OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE OSTEONICS CORP. 510(k) NO: K984585(TRADITIONAL) ATTN: MARYBETH NAUGHTON PHONE NO : 201-934-4376 59 ROUTE 17 SE DECISION MADE: 24-FEB-99 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEONICS COMBINATION SCREW RING/BLOCKER OSTEONICS CORP. 510(k) NO: K990158(SPECIAL) ATTN: KATE SUTTON PHONE NO : 201-825-4900 59 ROUTE 17 SE DECISION MADE: 01-FEB-99 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS OSTEONICS CORP. 510(k) NO: K990203(SPECIAL) ATTN: KATE SUTTON PHONE NO : 201-825-4900 59 ROUTE 17 SE DECISION MADE: 18-FEB-99 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEOMARK NTX SERUM EIA OSTEX INTL., INC. 510(k) NO: K983457(TRADITIONAL) ATTN: NANCY J.S. MALLINAK PHONE NO : 206-292-8082 2203 AIRPORT WAY SOUTH, SE DECISION MADE: 02-FEB-99 SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA SEATTLE, WA 98134 DEVICE: PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA PACIFIC HEMOSTASIS 510(k) NO: K990046(TRADITIONAL) ATTN: LAURA A WORFOLK PHONE NO : 800-528-0494 11515 VANSTORY DR. SE DECISION MADE: 17-FEB-99 HUNTERSVILLE, NC 28078-8144 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RE NU PACIFIC RIM DENTAL, INC. 510(k) NO: K973289(TRADITIONAL) ATTN: KATHY L EPPEN PHONE NO : 702-588-0555 173CD SHADY LANE SE DECISION MADE: 09-FEB-99 P.O. BOX 2147 510(k) STATEMENT STATELINE, NV 89449 DEVICE: SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM PERRY BAROMEDICAL SERVICES 510(k) NO: K983648(TRADITIONAL) ATTN: WAYNE C MCCULLOGH PHONE NO : 561-840-0395 7555 GARDEN ROAD SE DECISION MADE: 24-FEB-99 SUITE B 510(k) SUMMARY AVAILABLE FROM FDA RIVIERA BEACH, FL 33404 DEVICE: QUICK SCREEN METHADONE SCREENING TEST, MODELS 9035, 9036, QUICK PHAMATECH 510(k) NO: K982938(TRADITIONAL) ATTN: TUAN PHAM PHONE NO : 619-635-5840 9265 ACTIVITY RD., #112-113 SE DECISION MADE: 05-FEB-99 SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH50 PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K984545(TRADITIONAL) ATTN: P. ALTMAN PHONE NO : 203-926-7031 710 BRIDGEPORT AVENUE SE DECISION MADE: 25-FEB-99 P.O. BOX 860 510(k) SUMMARY AVAILABLE FROM FDA SHELTON, CT 06484-0917 DEVICE: PHASED ARRAY FLEXIBLE CARDIAC COIL PICKER INTL., INC. 510(k) NO: K984588(TRADITIONAL) ATTN: ELAINE K KEELER PHONE NO : 440-473-5591 595 MINER RD. SE DECISION MADE: 08-FEB-99 HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: "SURE" PLEASURE LATEX PRODUCTS SDN. BHD. 510(k) NO: K982380(TRADITIONAL) ATTN: CHANG AH KAU PHONE NO : 603 874 0784870784 LOT 1365, 17TH MILES, JALAN SE DECISION MADE: 26-FEB-99 SUNGAI SEMBILANG 510(k) STATEMENT JERAM, SELANGOR, MALAYSIA 45800 DEVICE: RIGID GAS PERMEABLE CONTACT LENS SOLUTION POLYMER TECHNOLOGY DIV. WILMINGTON510(k) NO: K983836(TRADITIONAL) ATTN: DEBRA L.B. KETCHUM PHONE NO : 716-338-8638 1400 NORTH GOODMAN STREET SE DECISION MADE: 11-FEB-99 ROCHESTER, NY 14692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MTM BIOSCANNER K TEST STRIPS POLYMER TECHNOLOGY SYSTEMS, INC. 510(k) NO: K981865(TRADITIONAL) ATTN: MARGO ENRIGHT PHONE NO : 317-870-5610 7736 ZIONSVILLE ROAD SE DECISION MADE: 26-FEB-99 INDIANAPOLIS, IN 46268 510(k) STATEMENT DEVICE: POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER POROUS MEDIA CORP. 510(k) NO: K982385(TRADITIONAL) ATTN: ROCHELLE M MICKSCHL PHONE NO : 612-653-2000 1350 HAMMOND RD. SE DECISION MADE: 01-FEB-99 ST. PAUL, MN 55110 510(k) STATEMENT DEVICE: PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL POSSIS MEDICAL, INC. 510(k) NO: K984182(TRADITIONAL) ATTN: TIMOTHY J KAPPERS PHONE NO : 612-780-4555 9055 EVERGREEN BLVD., N.W. SE DECISION MADE: 01-FEB-99 MINNEAPOLIS, MN 55433-8003 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451 POSSIS MEDICAL, INC. 510(k) NO: K984183(TRADITIONAL) ATTN: TIMOTHY J KAPPERS PHONE NO : 612-780-4555 9055 EVERGREEN BLVD., N.W. SE DECISION MADE: 01-FEB-99 MINNEAPOLIS, MN 55433-8003 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOL PROCATH CORP. 510(k) NO: K984150(SPECIAL) ATTN: JOSEPH C GRIFFIN, III PHONE NO : 609-753-8533 COOPER RUN EXECUTIVE PARK SE DECISION MADE: 22-FEB-99 575 RT. 73 NORTH, BLDG. D 510(k) STATEMENT WEST BERLIN, NJ 08091 DEVICE: QUANTASE PHE/GAL SCREENING ASSAY QUANTASE LTD. 510(k) NO: K984463(TRADITIONAL) ATTN: R. STEWART CAMPBELL PHONE NO : 440 173 8444102 3 RIVERVIEW BUSINESS PARK SE DECISION MADE: 16-FEB-99 FRIARTON ROAD 510(k) STATEMENT PERTH, SCOTLAND, UNITED KINGDOM PH2 8DF DEVICE: CBC-5D HEMATOLOGY CONTROL R & D SYSTEMS, INC. 510(k) NO: K983032(TRADITIONAL) ATTN: SUE GALLO PHONE NO : 612-379-2956 614 MCKINLEY PL., N.E. SE DECISION MADE: 17-FEB-99 MINNEAPOLIS, MN 55413 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FEMOSTOP COMPRESSION ARCH, FEMOSTOP PUMP, FEMOSTOP BILATERAL ADA RADI MEDICAL SYSTEMS AB 510(k) NO: K983471(TRADITIONAL) ATTN: MATS GRANLUND PHONE NO : 461 816 1000 PALMBLADSGATAN 10 SE DECISION MADE: 23-FEB-99 UPPSALA, SWEDEN S-754 50 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRESSUREWIRE SENSOR, MODEL #12001 RADI MEDICAL SYSTEMS AB 510(k) NO: K983506(TRADITIONAL) ATTN: MATS GRANLUND PHONE NO : 461 816 1000 PALMBLADSGATAN 10 SE DECISION MADE: 03-FEB-99 UPPSALA, SWEDEN S-754 50 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMAGEFUSION 2.0 RADIONICS, INC. 510(k) NO: K990071(SPECIAL) ATTN: NANCY C MACDONALD PHONE NO : 781-272-1233 22 TERRY AVE. SE DECISION MADE: 08-FEB-99 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGNETIC TIBC KIT REFERENCE DIAGNOSTICS, INC. 510(k) NO: K990216(TRADITIONAL) ATTN: JOSEPH LAWLOR PHONE NO : 781-276-9000 23 CROSBY DR. SE DECISION MADE: 16-FEB-99 BEDFORD, MA 01730-1401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IQ SYSTEM RENAISSANCE TECHNOLOGY, INC. 510(k) NO: K981720(TRADITIONAL) ATTN: PHILIP E HAMSKI PHONE NO : 215-860-5934 170 PHEASANT RUN SE DECISION MADE: 08-FEB-99 NEWTOWN, PA 18940 510(k) STATEMENT DEVICE: POTENCY TEST STRIPS, INDICATOR TEST STRIPS REPROCESSING PRODUCTS CORP. 510(k) NO: K974426(TRADITIONAL) ATTN: WALTER B JANSEN PHONE NO : 612-420-3355 8662 COMSTOCK LANE SE DECISION MADE: 10-FEB-99 MAPLE GROVE, MN 55311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MO RI. MOS. S.R.L 510(k) NO: K983897(TRADITIONAL) ATTN: ADENA S RIEMER PHONE NO : 978-371-0066 100 MAIN STREET SE DECISION MADE: 01-FEB-99 SUITE 120 510(k) SUMMARY AVAILABLE FROM FDA CONCORD, MA 01742 DEVICE: MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES ROCHE DIAGNOSTIC SYSTEMS 510(k) NO: K983702(TRADITIONAL) ATTN: RITA SMITH PHONE NO : 908-253-7545 BRANCHBURG TOWNSHIP SE DECISION MADE: 11-FEB-99 1080 U.S. HIGHWAY 202 510(k) SUMMARY AVAILABLE FROM FDA BRANCHBURG, NJ 08876-3771 DEVICE: MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE ROCHE DIAGNOSTIC SYSTEMS 510(k) NO: K983704(TRADITIONAL) ATTN: RITA SMITH PHONE NO : 908-253-7545 BRANCHBURG TOWNSHIP SE DECISION MADE: 10-FEB-99 1080 U.S. HIGHWAY 202 510(k) SUMMARY AVAILABLE FROM FDA BRANCHBURG, NJ 08876-3771 DEVICE: ONTRAK TESTCUP-5 M2K ROCHE DIAGNOSTICS CORP. 510(k) NO: K990337(TRADITIONAL) ATTN: JENNIFER L TRIBBETT PHONE NO : 317-576-3742 9115 HAGUE RD. SE DECISION MADE: 23-FEB-99 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 1 ROCHE DIAGNOSTICS CORP. 510(k) NO: K990377(TRADITIONAL) ATTN: JENNIFER TRIBBETT PHONE NO : 317-845-2000 9115 HAGUE RD. SE DECISION MADE: 26-FEB-99 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORE-IDE ROYDENT DENTAL PRODUCTS 510(k) NO: K984037(TRADITIONAL) ATTN: DONALD A LEROY PHONE NO : 248-652-2500 1010 WEST HAMLIN RD. SE DECISION MADE: 04-FEB-99 ROCHESTER HILLS, MI 48309 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SELF CATH SET/SAFETY CATH RUSCH INTERNATIONAL 510(k) NO: K983010(TRADITIONAL) ATTN: KARENANN J BROZOWSKI PHONE NO : 603-532-7706 TALL PINES PARK SE DECISION MADE: 12-FEB-99 JAFFREY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DC-CORE S & C POLYMER GMBH 510(k) NO: K984097(TRADITIONAL) ATTN: JURGEN ENGELBRECHT PHONE NO : 494 121 8619 SE DECISION MADE: 09-FEB-99 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A-SOFT RELINER S & C POLYMER GMBH 510(k) NO: K984483(TRADITIONAL) ATTN: JURGEN ENGELBRECHT PHONE NO : 494 121 8619 ROBERT-BOSCH-STR. 5 SE DECISION MADE: 18-FEB-99 D-25335 510(k) STATEMENT ELMSHORN, GERMANY DEVICE: SABRATEK 4040 INFUSION PUMP SABRATEK CORPORATION 510(k) NO: K980751(TRADITIONAL) ATTN: CHARLES P GILL PHONE NO : 847-588-2355 5601 WEST HOWARD SE DECISION MADE: 24-FEB-99 NILES, IL 60714 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCAREASE & SCAREASE ADHESIVE GEL SCAREASE, INC 510(k) NO: K984115(TRADITIONAL) ATTN: TED HARTLEY PHONE NO : 888-515-4141 PO BOX 500356 SE DECISION MADE: 12-FEB-99 POWAY, CA 92150 510(k) STATEMENT DEVICE: NUTRISAFE ENTERAL FEEDING TUBE SCHIFF & COMPANY 510(k) NO: K981629(TRADITIONAL) ATTN: ANNE M CESARIO PHONE NO : 201-277-1830 1129 BLOOMFIELD AVENUE SE DECISION MADE: 04-FEB-99 WEST CALDWELL, NJ 07006 510(k) STATEMENT DEVICE: SCICAN CLASSIC SCHOLLY FIBEROPTIC GMBH 510(k) NO: K984556(TRADITIONAL) ATTN: CARSTEN SCHLENKER PHONE NO : 004 966 908205 ROBERT-BOSCH-STR. 1-3 SE DECISION MADE: 09-FEB-99 DENZLINGEN, GERMANY D-79211 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCI-PHARM DFV VARNISH SCIENTIFIC PHARMACEUTICALS, INC. 510(k) NO: K982915(TRADITIONAL) ATTN: JAN A ORLOWSKI PHONE NO : 909-595-9922 3221 PRODUCER WAY SE DECISION MADE: 12-FEB-99 POMONA, CA 91768 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFANT FLOW NCPAP MASKS SENSORMEDICS CORP. 510(k) NO: K984254(TRADITIONAL) ATTN: PAUL L KITTINGER PHONE NO : 714-283-2228 22705 SAVI RANCH PKWY. SE DECISION MADE: 24-FEB-99 YORBA LINDA, CA 92887-4645 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES SHANGHAI HUAMAO GLOVES CO., LTD. 510(k) NO: K984460(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 55 NORTHERN BLVD, SUITE 200 SE DECISION MADE: 09-FEB-99 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRE-POWDER VINYL PATIENT EXAMINATION GLOVES SHANGHAI HUAMAO GLOVES CO., LTD. 510(k) NO: K984461(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 55 NORTHERN BLVD, SUITE 200 SE DECISION MADE: 09-FEB-99 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDERED SHANGHAI PALOMAR MOUNTAIN INDUSTRI510(k) NO: K990081(TRADITIONAL) ATTN: DANNY WANG PHONE NO : 011 862 157727722 #1 BIYU RD., CANGQIAO TOWNSHIP SE DECISION MADE: 19-FEB-99 SONGJIANG SHANGHAI, CHINA 510(k) STATEMENT DEVICE: DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE SHANGHAI PALOMAR MOUNTAIN INDUSTRI510(k) NO: K990117(TRADITIONAL) ATTN: DANNY WANG PHONE NO : 011 862 157727722 #1 BIYU RD.,CANGQIAO TOWNSHIP SE DECISION MADE: 19-FEB-99 SONGJIANG COUNTY 510(k) STATEMENT SHANGHAI, CHINA DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES SHIVA MEDICARE LTD. 510(k) NO: K984610(TRADITIONAL) ATTN: JAMES F LOGAN PHONE NO : 301-261-3776 314 N. HUNTER STREET SE DECISION MADE: 09-FEB-99 BALTIMORE, MD 21202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED NITRILE EXAMINATION GLOVES SHIVA MEDICARE LTD. 510(k) NO: K984615(TRADITIONAL) ATTN: JAMES F LOGAN PHONE NO : 310-261-3776 314 N. HUNTER STREET SE DECISION MADE: 17-FEB-99 BALTIMORE, MD 21202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR SIEMENS CORP. 510(k) NO: K984221(TRADITIONAL) ATTN: KATHLEEN RUTHERFORD PHONE NO : 732-321-4500 186 WOOD AVE., SOUTH SE DECISION MADE: 12-FEB-99 ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERFUSION PACKAGE FOR MAGNETOM VISION AND SYMPHONY SYSTEMS SIEMENS CORP. 510(k) NO: K984224(TRADITIONAL) ATTN: KATHLEEN RUTHERFORD PHONE NO : 732-321-4500 186 WOOD AVE., SOUTH SE DECISION MADE: 02-FEB-99 ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFINITY GLUCOSE REAGENT SIGMA DIAGNOSTICS 510(k) NO: K984574(TRADITIONAL) ATTN: WILLIAM R GILBERT PHONE NO : 314-286-6693 545 SOUTH EWING AVE. SE DECISION MADE: 11-FEB-99 ST.LOUIS, MO 63103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILIMED INFLATABLE (SALINE FILLED) BREAST IMPLANT SILIMED, LLC 510(k) NO: K974481(TRADITIONAL) ATTN: E J SMITH PHONE NO : 410-451-0639 P.O BOX 4341 SE DECISION MADE: 01-FEB-99 CROFTON, MD 21114 510(k) STATEMENT DEVICE: SILIMED PREFILLED SALINE BREAST IMPLANT SILIMED, LLC 510(k) NO: K980222(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 410-451-0639 P.O BOX 4341 SE DECISION MADE: 01-FEB-99 CROFTON, MD 21114 510(k) STATEMENT DEVICE: CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOI SIMS DELTEC, INC. 510(k) NO: K990083(TRADITIONAL) ATTN: EDWARD W NUMAINVILLE PHONE NO : 651-628-7166 1265 GREY FOX RD. SE DECISION MADE: 12-FEB-99 ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FO SMITH & NEPHEW ENT. 510(k) NO: K990213(SPECIAL) ATTN: JEFF COBB PHONE NO : 901-373-0200 2925 APPLING RD. SE DECISION MADE: 02-FEB-99 BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECHELON HIP STEM SMITH & NEPHEW, INC. 510(k) NO: K983834(ABBREVIATED) ATTN: JOANN KUHNE PHONE NO : 800-821-5700 1450 BROOKS RD. SE DECISION MADE: 24-FEB-99 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYBRISONIC SHEATH SONOTECH, INC. 510(k) NO: K983985(TRADITIONAL) ATTN: MARGARET J LARSON PHONE NO : 360-671-9121 774 MARINE DR. SE DECISION MADE: 25-FEB-99 BELLINGHAM, WA 98225 510(k) STATEMENT DEVICE: VIRILIS PENILE PROSTHESIS SPECIALTY SURGICAL PRODUCTS, INC. 510(k) NO: K983015(TRADITIONAL) ATTN: T.JAN VARNER PHONE NO : 406-375-0811 302 NORTH FIRST ST. SE DECISION MADE: 05-FEB-99 HAMILTON, MT 59840 510(k) STATEMENT DEVICE: MAMMARY SIZER, MAMMARY PROTHESIS SIZER SPECIALTY SURGICAL PRODUCTS, INC. 510(k) NO: K984106(TRADITIONAL) ATTN: T.JAN VARNER PHONE NO : 406-375-0811 302 NORTH FIRST ST. SE DECISION MADE: 12-FEB-99 HAMILTON, MT 59840 510(k) STATEMENT DEVICE: SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM SPINAL CONCEPTS, INC. 510(k) NO: K990005(TRADITIONAL) ATTN: PEPPER A CHASTAIN PHONE NO : 512-339-4800 820O CAMERON RD., SUITE B-160 SE DECISION MADE: 12-FEB-99 AUSTIN, TX 78754 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HUMMER TRAK SYSTEM STRYKER ENDOSCOPY 510(k) NO: K990038(TRADITIONAL) ATTN: DAVID HIMES PHONE NO : 408-567-2176 2590 WALSH AVE. SE DECISION MADE: 19-FEB-99 SANTA CLARA, CA 95051-4085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT SULZER ORTHOPEDICS, INC. 510(k) NO: K983509(TRADITIONAL) ATTN: SHAVAWN E PARDUHN PHONE NO : 512-432-9360 9900 SPECTRUM DR. SE DECISION MADE: 03-FEB-99 AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANATOMICA HUMERAL STEM/HEAD COMPONENTS SULZER ORTHOPEDICS, INC. 510(k) NO: K990137(TRADITIONAL) ATTN: MITCHELL A DHORITY PHONE NO : 512-432-9202 9900 SPECTRUM DR. SE DECISION MADE: 18-FEB-99 AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NBR 4 MILS, NITRILE EXAMINATION GLOVE NON-STERILE POWDERED SUMIRUBBER INDUSTRIES (KEDAH) SDN.510(k) NO: K984309(TRADITIONAL) ATTN: HIDEAKI OCHIAL PHONE NO : 044 213 121 LOT 44, 45 & 86 BAKAR ARANG SE DECISION MADE: 12-FEB-99 INDUSTRIAL ESTATE 510(k) STATEMENT 08000 SUNGAI PETANI, MALAYSIA 08000 DEVICE: NBR4 MILS NITRILE POWDER FREE EXAMINATION GLOVES NON-STERILE SUMIRUBBER INDUSTRIES (KEDAH) SDN.510(k) NO: K984311(TRADITIONAL) ATTN: HIDEAKI OCHIAI PHONE NO : 044 213 121 LOT 44, 45 & 86 BAKAR ARANG SE DECISION MADE: 09-FEB-99 INDUSTRIAL ESTATE 510(k) STATEMENT 08000 SUNGAI PETANI, MALAYSIA 08000 DEVICE: BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP SUNSCOPE INTERNATIONAL, INC. 510(k) NO: K983372(TRADITIONAL) ATTN: PHIL TRIOLO PHONE NO : 801-328-1996 148 SO. 1200 EAST SE DECISION MADE: 05-FEB-99 SALT LAKE CITY, UT 84102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDO ANALYZER, MODEL 8005, MODIFIED SYBRON DENTAL SPECIALITIES, INC. 510(k) NO: K990225(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVENUE SE DECISION MADE: 25-FEB-99 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLO PLUS ORTHO SYBRON DENTAL SPECIALITIES, INC. 510(k) NO: K990252(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVENUE SE DECISION MADE: 25-FEB-99 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM SYNTHES (USA) 510(k) NO: K984498(TRADITIONAL) ATTN: ANGELA J SILVESTRI PHONE NO : 610-647-9700 P.O. BOX 1766, 1690 RUSSELL SE DECISION MADE: 18-FEB-99 ROAD 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301 DEVICE: FREE FLOW SAFETY DEVICE, MODEL MG 245052 TEVA MEDICAL, LTD. 510(k) NO: K990288(TRADITIONAL) ATTN: MARYANN MELUS PHONE NO : 201-567-1010 482 HUDSON TERRACE SE DECISION MADE: 24-FEB-99 ENGLEWOOD CLIFFS, NJ 07632 510(k) STATEMENT DEVICE: ANTICARDIOLIPIN IGG SCREEN EIA DIAGNOSTIC TEST THE BINDING SITE, LTD. 510(k) NO: K983692(TRADITIONAL) ATTN: JAY H GELLER PHONE NO : 310-449-1399 EAST TOWER, SUITE 600 SE DECISION MADE: 05-FEB-99 2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT SANTA MONICA, CA 90404 DEVICE: ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT THE BINDING SITE, LTD. 510(k) NO: K983694(TRADITIONAL) ATTN: JAY H GELLER PHONE NO : 310-449-1399 EAST TOWER, SUITE 600 SE DECISION MADE: 05-FEB-99 2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT SANTA MONICA, CA 90404 DEVICE: ANTICARDIOLIPIN IGGAM SCREEN EIA DIAGNOSTIC TEST KIT THE BINDING SITE, LTD. 510(k) NO: K983695(TRADITIONAL) ATTN: JAY H GELLER PHONE NO : 310-449-1399 EAST TOWER, SUITE 600 SE DECISION MADE: 05-FEB-99 2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT SANTA MONICA, CA 90404 DEVICE: ANTICARDIOLIPIN IGA SCREEN EIA DIAGNOSTIC TEST KIT THE BINDING SITE, LTD. 510(k) NO: K983696(TRADITIONAL) ATTN: JAY H GELLER PHONE NO : 310-449-1399 EAST TOWER, SUITE 600 SE DECISION MADE: 05-FEB-99 2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT SANTA MONICA, CA 90404 DEVICE: ANTI-TPO EIA DIAGNOSTIC TEST KIT THE BINDING SITE, LTD. 510(k) NO: K984163(TRADITIONAL) ATTN: JAY H GELLER PHONE NO : 310-449-1399 EAST TOWER, SUITE 600 SE DECISION MADE: 02-FEB-99 2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT SANTA MONICA, CA 90404 DEVICE: ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT THE BINDING SITE, LTD. 510(k) NO: K984165(TRADITIONAL) ATTN: JAY H GELLER PHONE NO : 310-449-1399 EAST TOWER, SUITE 600 SE DECISION MADE: 02-FEB-99 2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT SANTA MONICA, CA 90404 DEVICE: BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT THE BINDING SITE, LTD. 510(k) NO: K984619(TRADITIONAL) ATTN: JAY H GELLER PHONE NO : 310-449-1399 EAST TOWER, SUITE 600 SE DECISION MADE: 23-FEB-99 2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT SANTA MONICA, CA 90404 DEVICE: CROSS SPORT, RIGID WHEELCHAIR TISPORT 510(k) NO: K990358(TRADITIONAL) ATTN: SANDRA GLADSTONE PHONE NO : 509-586-6117 1426 EAST THIRD AVENUE SE DECISION MADE: 26-FEB-99 KENNEWICK, WA 99337 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRONOSCO X-POSURE SYSTEM TORSANA OSTEOPOROSIS DIAGNOSTICS A510(k) NO: K984178(TRADITIONAL) ATTN: JONATHAN S KAHAN, ESQ PHONE NO : 202-637-5794 555 13TH STREET, N.W. SE DECISION MADE: 18-FEB-99 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXART,FLEXART/HYPER, VISART, VISART/HYPER TOSHIBA AMERICA MRI, INC. 510(k) NO: K983110(TRADITIONAL) ATTN: KEN NEHMER PHONE NO : 650-872-2722 280 UTAH AVE. SE DECISION MADE: 25-FEB-99 SOUTH SAN FRANCISCO, CA 94080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000 TREX MEDICAL CORP. 510(k) NO: K984091(TRADITIONAL) ATTN: WALTER F SCHNEIDER PHONE NO : 516-691-6100 445 OAK ST. SE DECISION MADE: 05-FEB-99 COPIAGUE, NY 11726-2719 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000 TREX MEDICAL CORP. 510(k) NO: K984092(TRADITIONAL) ATTN: WALTER F SCHNEIDER PHONE NO : 516-691-6100 445 OAK ST. SE DECISION MADE: 05-FEB-99 COPIAGUE, NY 11726-2719 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNI-GOLD STREP A TEST KIT TRINITY BIOTECH, PLC 510(k) NO: K982373(TRADITIONAL) ATTN: ERIKA B AMMIRATI PHONE NO : 650-949-2768 575 SHIRLYNN COURT SE DECISION MADE: 11-FEB-99 LOS ALTOS, CA 94022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHEER THIN TWE COMPANIES, INC. 510(k) NO: K984488(TRADITIONAL) ATTN: KEITH F HEINTZ PHONE NO : 404-296-0750 46 FRANKLIN STREET SE DECISION MADE: 01-FEB-99 AVONDALE ESTATES, GA 30002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR UNIPATH LTD. 510(k) NO: K990223(SPECIAL) ATTN: LOUISE ROBERTS PHONE NO : 441 234 835564 PRIORY BUSINESS PARK SE DECISION MADE: 24-FEB-99 BEDFORD, UNITED KINGDOM MK44 3UP 510(k) STATEMENT DEVICE: AUTO SUTURE SITE MARKER CLIP UNITED STATES SURGICAL CORP. 510(k) NO: K983400(TRADITIONAL) ATTN: CHRISTOPHER A GRAHAM PHONE NO : 203-845-1390 150 GLOVER AVE. SE DECISION MADE: 10-FEB-99 NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLORVEES IV SET 20 DROPS/ML 105", 60 DROPS/ML 105", VENTED 20 D VALNET MEDICAL CORP. 510(k) NO: K983411(TRADITIONAL) ATTN: VICTOR M ORTIZ MEDINA PHONE NO : 787-845-2727 B ST., FELICIA INDUSTRIAL PARK SE DECISION MADE: 09-FEB-99 (PLAYA) LOT #16 510(k) SUMMARY AVAILABLE FROM FDA SANTA ISABEL, PR 00757-0859 DEVICE: MILLENNIUM MLC -120 VARIAN ASSOC., INC. 510(k) NO: K990085(SPECIAL) ATTN: LINDA S NASH PHONE NO : 650-424-6990 3045 HANOVER STREET SE DECISION MADE: 08-FEB-99 MAIL STOP H-055 510(k) SUMMARY AVAILABLE FROM FDA PALO ALTO, CA 94304-1129 DEVICE: 2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT) VASCUTECH, INC. 510(k) NO: K980723(TRADITIONAL) ATTN: GEORGE W LEMAITRE PHONE NO : 781-221-2266 164 MIDDLESEX TURNPIKE SE DECISION MADE: 12-FEB-99 BURLINGTON, MA 01803 510(k) STATEMENT DEVICE: VENTLAB VERIFY II VENTLAB CORP. 510(k) NO: K990098(TRADITIONAL) ATTN: E J SMITH PHONE NO : 410-451-0639 PO BOX 4341 SE DECISION MADE: 11-FEB-99 CROFTON, MD 21114-4341 510(k) STATEMENT DEVICE: WIDE BODY ABUTMENTS VIDENT 510(k) NO: K984198(TRADITIONAL) ATTN: BARBARA J LEWANDOWSKI PHONE NO : 714-961-6200 3150 EAST BIRCH ST. SE DECISION MADE: 18-FEB-99 BREA, CA 92821 510(k) STATEMENT DEVICE: GAUZE, SPONGES, CAT # 11-003 VITALCARE GROUP 510(k) NO: K983016(TRADITIONAL) ATTN: GINGER TALLEY PHONE NO : 305-620-4007 15800 N.W. 13TH AVE. SE DECISION MADE: 12-FEB-99 MIAMI, FL 33169 510(k) STATEMENT DEVICE: WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000 WALLAC INC. 510(k) NO: K982307(TRADITIONAL) ATTN: JANICE K BROWNLEE PHONE NO : 330-825-4525 3985 EASTERN RD. SE DECISION MADE: 02-FEB-99 NORTON, OH 44203 510(k) STATEMENT DEVICE: ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000 WALLACE A. ERICKSON & CO. 510(k) NO: K984503(TRADITIONAL) ATTN: ABNER T DE LA CRUZ PHONE NO : 773-327-9457 1920 NORTH CLYBOURN AVE. SE DECISION MADE: 26-FEB-99 CHICAGO, IL 60614 510(k) STATEMENT DEVICE: WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR WALLACH SURGICAL DEVICES, INC. 510(k) NO: K983208(TRADITIONAL) ATTN: MICHAEL MALIS PHONE NO : 203-799-2000 235 EDISON RD. SE DECISION MADE: 22-FEB-99 ORANGE, CT 06477 510(k) STATEMENT DEVICE: WELCH ALLYN FRONT-LINE DOC WELCH ALLYN, INC. 510(k) NO: K984215(TRADITIONAL) ATTN: COLIN WOLFF PHONE NO : 315-685-2525 4341 STATE STREET ROAD SE DECISION MADE: 11-FEB-99 P.O. BOX 220 510(k) SUMMARY AVAILABLE FROM FDA SKANEATELES FALLS, NY 13153-0220 DEVICE: WILSON-COOK PANCREATIC WEDGE STENT WILSON-COOK MEDICAL, INC. 510(k) NO: K990130(SPECIAL) ATTN: PAULA JOYCE PHONE NO : 800-245-4707 4900 BETHANIA STATION RD. SE DECISION MADE: 12-FEB-99 WINSTON-SALEM, NC 27105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHRO-SURGIMAT-2000 ECU WOM GMBH 510(k) NO: K990443(SPECIAL) ATTN: MICHAEL MCGRAIL PHONE NO : 508-337-2188 194 BRANCH ST SE DECISION MADE: 26-FEB-99 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RELIEFBAND MST DEVICE, MODELS RB-2, RB-6, RB-R WOODSIDE BIOMEDICAL, INC. 510(k) NO: K982967(TRADITIONAL) ATTN: CAROL PATTERSON PHONE NO : 619-451-0642 18140 SMOKESIGNAL DRIVE SE DECISION MADE: 23-FEB-99 SAN DIEGO, CA 92127 510(k) STATEMENT DEVICE: ADVANCED REVISION PRODUCT LINE EXTENSION WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K990030(ABBREVIATED) ATTN: LYNNE WITKOWSKI PHONE NO : 901-867-9971 5677 AIRLINE RD. SE DECISION MADE: 03-FEB-99 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAG XITEC 510(k) NO: K984406(TRADITIONAL) ATTN: SHEILA M HEMEON-HEYER PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 02-FEB-99 NORTH ATTLEBORO, MA 02760-4153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEROGEL NASAL DRESSING AND SINUS STENT XOMED, INC. 510(k) NO: K982731(TRADITIONAL) ATTN: ROY BERENS PHONE NO : 6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 02-FEB-99 JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XPS TISSUE ASPIRATION SYSTEM, XPS STRAIGHTSHOT OR MODEL 2000 MIC XOMED, INC. 510(k) NO: K984363(TRADITIONAL) ATTN: DAVID TIMLIN PHONE NO : 904-279-7532 6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 26-FEB-99 JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW ZYMED MEDICAL INSTRUMENTATION 510(k) NO: K984089(TRADITIONAL) ATTN: DUDLEY HARRIS PHONE NO : 800-235-5941 20 NORTH AVIADOR STREET SE DECISION MADE: 16-FEB-99 CAMARILLO, CA 93010 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 316 TOTAL WITH SUMMARIES 224 TOTAL WITH STATEMENTS 92
Updated 3/14/2000
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