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510(k)s Final Decisions Rendered for February 1999 |
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SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-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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