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510(k)s Final Decisions Rendered for Auguat 1999 |
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DEVICE: HOFFMAN IVF-1 (ARMS) HOFFMAN SURGICAL EQUIPMENT,510(k) NO: K991216(TRADITIONAL) ATTN: FRANK STRZEMPEK PHONE NO : 610-834-1450 555 NORTH LANE SE DECISION MADE: 05-AUG-99 SUITE 5001 510(k) STATEMENT CONSHOHOCKEN, PA 19428 DEVICE: HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2 02 MARKETING GROUP INC 510(k) NO: K991569(TRADITIONAL) ATTN: LESTER FORD PHONE NO : 770-663-3090 11285 ELKINS RD SE DECISION MADE: 03-AUG-99 SUITE H5 510(k) STATEMENT ROSWELL, GA 30076 DEVICE: 3M LVR SYSTEM 3M CO. 510(k) NO: K991961(TRADITIONAL) ATTN: LAEL J PICKETT PHONE NO : 651-733-3594 3M CENTER BUILDING 26O-2B-12 SE DECISION MADE: 09-AUG-99 ST. PAUL, MN 55144-1000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01 A.P. TOTAL CARE, INC. 510(k) NO: K991664(TRADITIONAL) ATTN: LUIS P LEON PHONE NO : 203-335-9277 70 HAWLEY AVE, SE DECISION MADE: 19-AUG-99 PO BOX 6216 510(k) STATEMENT BRIDGEPORT, CT DEVICE: HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01 A.P. TOTAL CARE, INC. 510(k) NO: K991665(TRADITIONAL) ATTN: LUIS P LEON PHONE NO : 203-335-9277 70 HAWLEY AVE, SE DECISION MADE: 10-AUG-99 PO BOX 6216 510(k) STATEMENT BRIDGEPORT, CT DEVICE: BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, A.P. TOTAL CARE, INC. 510(k) NO: K991866(TRADITIONAL) ATTN: LUIS P LEON PHONE NO : 203-335-9277 70 HAWLEY AVE, SE DECISION MADE: 02-AUG-99 PO BOX 6216 510(k) STATEMENT BRIDGEPORT, CT DEVICE: INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 A.P. TOTAL CARE, INC. 510(k) NO: K991867(TRADITIONAL) ATTN: LUIS P LEON PHONE NO : 203-906-7800 70 HAWLEY AVE, SE DECISION MADE: 02-AUG-99 PO BOX 6216 510(k) STATEMENT BRIDGEPORT, CT DEVICE: AB2 MED-FLO SOLUTION SET AB2 MEDICAL PRODUCTS, LLP 510(k) NO: K984569(TRADITIONAL) ATTN: ARTHUR CHANDLER,III PHONE NO : 281-362-0130 52 BUTTONBUSH CT SE DECISION MADE: 12-AUG-99 THE WOODLANDS, TX 510(k) STATEMENT DEVICE: PICCOLO METLYTE 7 REAGENT DISC ABAXIS INC. 510(k) NO: K992140(TRADITIONAL) ATTN: LISA MCGRATH PHONE NO : 408-745-6880 1320 CHESAPEAKE TERRACE SE DECISION MADE: 26-AUG-99 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER ABX DIAGNOSTICS, INC. 510(k) NO: K991839(TRADITIONAL) ATTN: PAT AMTOWER PHONE NO : 949-489-3913 7777 CENTER AVENUE SE DECISION MADE: 11-AUG-99 SUITE 102 510(k) SUMMARY AVAILABLE FROM FDA HUNTINGTON BEACH, CA 92647 DEVICE: ACRY ISLAND BORDER DRESSING, MODELS 2031, 2032, 2033 ACRYMED, INC. 510(k) NO: K992032(TRADITIONAL) ATTN: BRUCE GIBBINS PHONE NO : 503-624-9830 12232 S.W. GARDEN PL. SE DECISION MADE: 19-AUG-99 PORTLAND, OR 97223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION ACUSON CORP. 510(k) NO: K991805(TRADITIONAL) ATTN: WILLIAM WELCH PHONE NO : 650-943-7286 1220 CHARLESTON RD. SE DECISION MADE: 02-AUG-99 MOUNTAIN VIEW, CA 94039-7393 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM ADVANCED TECHNOLOGY LABORATORIES, 510(k) NO: K992470(TRADITIONAL) ATTN: TERRENCE J SWEENEY PHONE NO : 425-487-7602 P.O. BOX 3003 SE DECISION MADE: 23-AUG-99 BOTHELL, WA 98041-3003 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTELLIFLO SPACER AEROMAX TECHNOLOGIES, INC. 510(k) NO: K984085(TRADITIONAL) ATTN: ALLAN M WACHTER PHONE NO : 602-785-8000 12020 S. WARNER/ELLIOT LOOP SE DECISION MADE: 05-AUG-99 SUITE 124 510(k) STATEMENT PHOENIX, AZ 85044 DEVICE: ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY AIRSEP CORP. 510(k) NO: K992283(TRADITIONAL) ATTN: GREG DZIOMBA PHONE NO : 716-691-0202 290 CREEKSIDE DR. SE DECISION MADE: 27-AUG-99 BUFFALO, NY 14228-2070 510(k) STATEMENT DEVICE: BIOSHIELD EXPRESS STERILIZATION WRAP ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K983719(TRADITIONAL) ATTN: PATRICIA SHARPE-GREGG PHONE NO : 847-578-3636 1500 WAUKEGAN RD. SE DECISION MADE: 25-AUG-99 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONVERTORS BREATHABLE SURGICAL GOWNS ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K992514(SPECIAL) ATTN: SHARON ROBBINS PHONE NO : 847-785-3311 1500 WAUKEGAN RD. SE DECISION MADE: 12-AUG-99 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, DARK BLUE ALLIANCE RUBBER PRODUCTS SDN. BHD.510(k) NO: K991981(TRADITIONAL) ATTN: CHUA HOOI KOON PHONE NO : 600 459 32235 PERINDUSTRIAN BUKIT PANCHOR SE DECISION MADE: 05-AUG-99 14300 NIBONG TEBAL 510(k) STATEMENT PULAU PINANG, MALAYSIA 52446-U DEVICE: ALOKA SSD-5500 DIAGNOSTIC ULTRASOUND SYSTEM ALOKA CO., LTD. 510(k) NO: K992663(TRADITIONAL) ATTN: CHRIS BOHL PHONE NO : 203-269-5088 10 FAIRFIELD BLVD. SE DECISION MADE: 24-AUG-99 WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEPTUNE WASTE MANAGEMENT SYSTEM AMERICAN IMMUNO TECH 510(k) NO: K990037(TRADITIONAL) ATTN: ESTHER SALTZ PHONE NO : 949-830-4235 320 KALMUS DRIVE SE DECISION MADE: 24-AUG-99 COSTA MESA, CA 92626 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FETALGARD 3000 FETAL MONITOR ANALOGIC CORP. 510(k) NO: K983395(TRADITIONAL) ATTN: STEVEN CLARKE PHONE NO : 978-977-3000 8 CENTENNIAL DR. SE DECISION MADE: 12-AUG-99 PEABODY, MA 01960 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APPLIED BIOTECH SURESTEP HCG/COMBO (II) PREGNANCY TEST APPLIED BIOTECH, INC. 510(k) NO: K992187(TRADITIONAL) ATTN: ROGER KOTTER PHONE NO : 619-587-6771 10237 FLANDERS CT. SE DECISION MADE: 04-AUG-99 SAN DIEGO, CA 92121 510(k) STATEMENT DEVICE: THERMOFLEX SYSTEM ARGOMED, INC. 510(k) NO: K991847(TRADITIONAL) ATTN: RICHARD B KLEIN PHONE NO : 919-469-2340 3800 GATEWAY CENTER BLVD SE DECISION MADE: 26-AUG-99 MORRISVILLE, NC 27560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHREX MENISCAL DART SYSTEM ARTHREX, INC. 510(k) NO: K983577(TRADITIONAL) ATTN: SCOTT M DURLACHER PHONE NO : 941-643-5553 2885 SOUTH HORSESHOE DR. SE DECISION MADE: 13-AUG-99 NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVANTA GRAFT ATRIUM MEDICAL CORP. 510(k) NO: K992441(SPECIAL) ATTN: KAREN HALL PHONE NO : 603-880-1433 5 WENTWORTH DR. SE DECISION MADE: 20-AUG-99 HUDSON, NH 03051 510(k) STATEMENT DEVICE: ADVANTA GRAFT ATRIUM MEDICAL CORP. 510(k) NO: K992443(SPECIAL) ATTN: KAREN HALL PHONE NO : 603-880-1433 5 WENTWORTH DR. SE DECISION MADE: 20-AUG-99 HUDSON, NH 03051 510(k) STATEMENT DEVICE: JOBST READY-TO-WEAR ARM SLEEVES BEIERSDORF-JOBT, INC. 510(k) NO: K991570(TRADITIONAL) ATTN: ANGELO R PEREIRA PHONE NO : 704-551-7178 5825 CARNEGIE BLVD. SE DECISION MADE: 20-AUG-99 CHARLOTTE, NC 28209-4633 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) BELMONT INSTRUMENT CORP. 510(k) NO: K992672(SPECIAL) ATTN: URAIWAN LABADINI PHONE NO : 978-663-0212 780 BOSTON RD. SE DECISION MADE: 24-AUG-99 BILLERICA, MA 01821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MED-RX EXTENSION SETS BENLAN INC. 510(k) NO: K990777(TRADITIONAL) ATTN: BILL C.K. LIM PHONE NO : 905 829 5004 2760 BRIGHTON RD. SE DECISION MADE: 25-AUG-99 OAKVILLE, ONTARIO, CANADA L6H 5T4 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV- BERTEC CORP. 510(k) NO: K991642(ABBREVIATED) ATTN: DOUG MORR PHONE NO : 614-430-5421 6185 HUNTLY ROAD SE DECISION MADE: 03-AUG-99 SUITE B 510(k) STATEMENT WORTHINGTON, OH 43229 DEVICE: BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TES BINAX, INC. 510(k) NO: K991726(TRADITIONAL) ATTN: PAMELA S ANGELL PHONE NO : 207-772-3988 217 READ ST. SE DECISION MADE: 27-AUG-99 PORTLAND, ME 04103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, 3 BIO-RAD LABORATORIES, INC. 510(k) NO: K992550(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO RD. SE DECISION MADE: 11-AUG-99 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECTRO-NERVE STIMULATOR TENS, MODEL "LX" BIOMEDICAL LIFE SYSTEMS, INC. 510(k) NO: K990230(ABBREVIATED) ATTN: RICHARD SAXON PHONE NO : 760-727-5600 2448 CADES WAY SE DECISION MADE: 19-AUG-99 VISTA, CA 92083 510(k) STATEMENT DEVICE: BIPOLAR SHOULDER PROSTHESIS BIOMET, INC. 510(k) NO: K991585() ATTN: FRED MCCLURE PHONE NO : 219-372-1568 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 18-AUG-99 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: MAXIM REMOVABLE MOLDED POLY TIBIA BIOMET, INC. 510(k) NO: K991753(TRADITIONAL) ATTN: FRED MCCLURE PHONE NO : 219-372-1568 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 17-AUG-99 WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LACTOSORB SHEETS BIOMET, INC. 510(k) NO: K992158(TRADITIONAL) ATTN: MICHELLE L MCKINLEY PHONE NO : 219-267-6639 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 20-AUG-99 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: ANATOMICAL BANKART TACK, MODEL 523520A BIONX IMPLANTS, LTD. 510(k) NO: K992567(SPECIAL) ATTN: TUIJA ANNALA PHONE NO : 358 331 65600 P.O. BOX 3 SE DECISION MADE: 27-AUG-99 HERMINKATU 6-8L 510(k) SUMMARY AVAILABLE FROM FDA TAMPERE, FINLAND FIN-33720 DEVICE: STREP B OIA BIOSTAR, INC. 510(k) NO: K991828(TRADITIONAL) ATTN: ROGER C BRIDEN PHONE NO : 303-530-3888 6655 LOOKOUT RD. SE DECISION MADE: 19-AUG-99 BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POST CEMENT HI-X BISCO, INC. 510(k) NO: K992248(TRADITIONAL) ATTN: KATHRYN B PATTERSON PHONE NO : 847-534-6146 1100 WEST IRVING PARK RD. SE DECISION MADE: 25-AUG-99 SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCIMED IMPULSE ANGIOGRAPHIC CATHETERS BOSTON SCIENTIFIC/SCIMED 510(k) NO: K992123(TRADITIONAL) ATTN: MELANIE RASKA PHONE NO : 800-553-5878 ONE SCIEMD PLACE SE DECISION MADE: 23-AUG-99 MAPLE GROVE, MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO F BUFFALO FILTER CO., INC. 510(k) NO: K983298(TRADITIONAL) ATTN: CLINTON R HOLLAND JR. PHONE NO : 716-835-7000 6000 N. BAILEY AVE, SUITE 9 SE DECISION MADE: 16-AUG-99 BUFFALO, NY 14226 510(k) STATEMENT DEVICE: BUFFALO FILTER VIROSAFE HRF- #VSHRFO1 BUFFALO FILTER CO., INC. 510(k) NO: K983333(TRADITIONAL) ATTN: CLINTON R HOLLAND JR PHONE NO : 716-835-7000 6000 N. BAILEY AVE, SUITE 9 SE DECISION MADE: 11-AUG-99 BUFFALO, NY 14226 510(k) STATEMENT DEVICE: BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801 BUFFALO FILTER CO., INC. 510(k) NO: K983364(TRADITIONAL) ATTN: CLINTON R HOLLAND JR. PHONE NO : 716-835-7000 6000 N. BAILEY AVE, SUITE 9 SE DECISION MADE: 11-AUG-99 BUFFALO, NY 14226 510(k) STATEMENT DEVICE: CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY CANTOR & SILVER LTD. 510(k) NO: K992500(TRADITIONAL) ATTN: MARTIN DALSING PHONE NO : 970-243-5490 623 GLACIER DRIVE SE DECISION MADE: 18-AUG-99 GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARD GUARD, MODEL CG-6550 CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K990478(TRADITIONAL) ATTN: LEONID TRACHTENBERG PHONE NO : 972 894 84600 2 PEKERIS STREET SE DECISION MADE: 31-AUG-99 REHOVOT, ISRAEL 510(k) STATEMENT DEVICE: TELEMEDICINE 2000 CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K992164(SPECIAL) ATTN: LEONID TRACHTENBERG PHONE NO : 972 899 484600 2 PERERIS ST., SCIENCE PARK SE DECISION MADE: 30-AUG-99 REHOVOT, ISRAEL 76100 510(k) STATEMENT DEVICE: CARESIDE AMMONIA CARESIDE, INC. 510(k) NO: K991371(TRADITIONAL) ATTN: KENNETH B ASSARCH, PHARM PHONE NO : 310-338-6767 6100 BRISTOL PARKWAY SE DECISION MADE: 03-AUG-99 CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARESIDE MG CARESIDE, INC. 510(k) NO: K991717(TRADITIONAL) ATTN: KENNETH B ASARCH PHONE NO : 310-338-6767 6100 BRISTOL PARKWAY SE DECISION MADE: 10-AUG-99 CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE CENOGENICS CORP. 510(k) NO: K992397(TRADITIONAL) ATTN: NITZA KATZ PHONE NO : 732-536-6457 100 RT. 520 SE DECISION MADE: 26-AUG-99 MORGANVILLE, NJ 07751 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER) CHARTER MEDICAL, LTD. 510(k) NO: K990310(TRADITIONAL) ATTN: DAVID HEAGLE PHONE NO : 732-901-9400 1805 SWARTHMORE AVE. SE DECISION MADE: 30-AUG-99 LAKEWOOD, NJ 08701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965 CHEMICON INTL., INC. 510(k) NO: K992252(SPECIAL) ATTN: CINDY PENNY PHONE NO : 909-676-8080 28835 SINGLE OAK DRIVE SE DECISION MADE: 10-AUG-99 TEMECULA, CA 92590 510(k) STATEMENT DEVICE: CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY CHIRON DIAGNOSTICS CORP. 510(k) NO: K992157(TRADITIONAL) ATTN: WILLIAM J PIGNATO PHONE NO : 508-359-3825 63 NORTH ST. SE DECISION MADE: 05-AUG-99 MEDFIELD, MA 02052-1688 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DAILIES (NELFILCON A) ONE-DAY CIBA VISION JOHNS CREEK MFG. 510(k) NO: K992446(TRADITIONAL) ATTN: ALICIA M PLESNARSKI PHONE NO : 678-415-3924 11460 JOHNS CREEK PARKWAY SE DECISION MADE: 18-AUG-99 DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM CIRCON CORP. 510(k) NO: K992126(TRADITIONAL) ATTN: RONALD J EHMSEN PHONE NO : 805-961-3290 6500 HOLLISTER AVENUE SE DECISION MADE: 03-AUG-99 SANTA BARBARA, CA 93117-3019 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, CIVCO MEDICAL INSTRUMENTS CO., INC510(k) NO: K992152(TRADITIONAL) ATTN: J. WILLIAM JONES PHONE NO : 319-656-4447 102 FIRST ST. SOUTH SE DECISION MADE: 17-AUG-99 KALONA, IA 52247 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA COGENT DIAGNOTICS LTD. 510(k) NO: K991890(TRADITIONAL) ATTN: DANIELLE M KNIGHT PHONE NO : 714-933-3000 PENTLANDS SCIENCE PARK SE DECISION MADE: 09-AUG-99 BUSH LOAN 510(k) STATEMENT EDINBURGH, UNITED KINGDOM EH26 OPL DEVICE: AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA COGENT DIAGNOTICS LTD. 510(k) NO: K991942(TRADITIONAL) ATTN: DANIELLE M KNIGHT PHONE NO : 714-933-3000 PENTLANDS SCIENCE PARK SE DECISION MADE: 24-AUG-99 BUSH LOAN 510(k) STATEMENT EDINBURGH, UNITED KINGDOM EH26 OPL DEVICE: COLORSOFT PROSTHETIC TINTED SOFT CONTACT LENS COLORSOFT LABORATORIES CORP. 510(k) NO: K992339(TRADITIONAL) ATTN: MARTIN DALSING PHONE NO : 970-243-5490 623 GLACIER DRIVE SE DECISION MADE: 16-AUG-99 GRANT JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONWAY STUART MODEL 100 IRRIGATION PUMP & ACCESSORIES CONWAY STUART MEDICAL, INC. 510(k) NO: K990724(TRADITIONAL) ATTN: THOMAS WEHMAN PHONE NO : 408-733-9910 735 PALOMAR ST. SE DECISION MADE: 13-AUG-99 SUNNYVALE, CA 94086 510(k) STATEMENT DEVICE: URETHANE PICC LINE MODEL UPICS- COOK, INC. 510(k) NO: K992198(SPECIAL) ATTN: LISA WEBB PHONE NO : 812-339-2235 925 SOUTH CURRY PIKE SE DECISION MADE: 27-AUG-99 BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND ACCESSOR CORDIS CORP. 510(k) NO: K991028(TRADITIONAL) ATTN: CHARLES J RYAN PHONE NO : 908-412-7446 40 TECHNOLOGY DRIVE SE DECISION MADE: 04-AUG-99 WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY CORDIS CORP. 510(k) NO: K991674(TRADITIONAL) ATTN: CHARLES J RYAN PHONE NO : 908-412-7446 40 TECHNOLOGY DR. SE DECISION MADE: 12-AUG-99 WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER CORDIS ENDOVASCULAR SYSTEMS, INC. 510(k) NO: K984214(TRADITIONAL) ATTN: ALINA CARABALLO PHONE NO : 305-512-6518 14000 N.W. 57TH CT. SE DECISION MADE: 10-AUG-99 MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: N LATEX STFR REAGENT DADE BEHRING, INC. 510(k) NO: K991157(TRADITIONAL) ATTN: CAROLYN K GEORGE PHONE NO : 781-826-2073 GLASGOW SITE SE DECISION MADE: 02-AUG-99 P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714 DEVICE: TRIP TONOMETRY CATHETER, 8F DATEX-OHMEDA, INC. 510(k) NO: K992181(TRADITIONAL) ATTN: JOEL KENT PHONE NO : 978-640-0460 TEWKSBURY, MA 01876 510(k) STATEMENT DEVICE: DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT DENTSPLY INTL. 510(k) NO: K991909(TRADITIONAL) ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511 570 WEST COLLEGE AVE SE DECISION MADE: 20-AUG-99 YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYRACT SEAL COMPOMER PIT & FISSURE SEALANT DENTSPLY INTL. 510(k) NO: K992516(TRADITIONAL) ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511 570 WEST COLLEGE AVE SE DECISION MADE: 27-AUG-99 YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING DERMAPHYLYX, INC. 510(k) NO: K991920(TRADITIONAL) ATTN: ANDREW M REED PHONE NO : 303-431-6796 12106, WEST 75TH LANE SE DECISION MADE: 12-AUG-99 ARVADA, CO 80005-5306 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POCKIT HSV 2 RAPI D TEST DIAGNOLOGY LTD. 510(k) NO: K983886(TRADITIONAL) ATTN: ROBERT SCHIFF PHONE NO : 973-227-1830 1129 BLOOMFIELD AVENUE SE DECISION MADE: 19-AUG-99 WEST CALDWELL, NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARAMED PARAFFIN WARMER DIVI INTL. CO. 510(k) NO: K991427(TRADITIONAL) ATTN: MIKE VIDAL PHONE NO : 305-253-9200 12188 S.W. 128TH ST. SE DECISION MADE: 13-AUG-99 MIAMI, FL 33186 510(k) STATEMENT DEVICE: ATC OPTION FOR EVITA 2 DURA AND EVITA 4 DRAGER, INC. 510(k) NO: K992608(SPECIAL) ATTN: HARALD KNEUER PHONE NO : 215-721-6910 3136 QUARRY RD. SE DECISION MADE: 24-AUG-99 TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUTECK DIGITAL CLINICAL THERMOMETER DUTECK INDUSTRIAL CO., LTD. 510(k) NO: K992327(TRADITIONAL) ATTN: ALLEN REICH PHONE NO : 520-773-9488 900 N. SWITZER DR. #142 SE DECISION MADE: 18-AUG-99 FLAGGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBI OMEGA 21 SYSTEM EBI ELECTRO BIOLOGY 510(k) NO: K991721(TRADITIONAL) ATTN: JONAS WILF PHONE NO : 973-299-9022 100 INTERPACE PARKWAY SE DECISION MADE: 13-AUG-99 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBI XFIX DFS OPTIROM ELBOW FIXATOR EBI, L.P. 510(k) NO: K992515(SPECIAL) ATTN: JONAS WILF PHONE NO : 973-299-9022 100 INTERPACE PKWY. SE DECISION MADE: 17-AUG-99 PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERMITTENT COMPRESSION BOOT FOR OTC EISCHOCO, INC. 510(k) NO: K991921(TRADITIONAL) ATTN: JACK SPEER PHONE NO : 801-582-6470 1232 S.E. 282ND AVENUE SE DECISION MADE: 13-AUG-99 GRESHAM, OR 97080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNAWELL OR DYNAWELL EKEROTH QUALITY AB 510(k) NO: K992120(TRADITIONAL) ATTN: NILS EKEROTH PHONE NO : NYBROKAJEN 7 SE DECISION MADE: 13-AUG-99 STOCKHOLM, SWEDEN 102 41 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KI ELAN DIAGNOSTICS 510(k) NO: K992029(TRADITIONAL) ATTN: WYNN STOCKING PHONE NO : 714-871-8360 231 NORTH PUENTE ST. SE DECISION MADE: 12-AUG-99 BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBI XFIX DFS RAIL SYSTEM ELECTRO-BIOLOGY, INC. 510(k) NO: K991941(TRADITIONAL) ATTN: JONAS WILF PHONE NO : 973-299-9022 100 INTERPACE PKWY. SE DECISION MADE: 19-AUG-99 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HAWKEYE OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA ELGEMS, LTD. 510(k) NO: K991841(TRADITIONAL) ATTN: DAN LAOR PHONE NO : 972 485 63666 P.O. BOX 170 SE DECISION MADE: 26-AUG-99 TIRAT HACARMEL, ISRAEL 30200 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MG ATC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANG ELGEMS, LTD. 510(k) NO: K991896(TRADITIONAL) ATTN: LAOR DAN PHONE NO : 972 483 10335 P.O. BOX 170 SE DECISION MADE: 23-AUG-99 TIRAT HACARMEL, ISRAEL 30200 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTIMAX ANKLE FUSION ROD SYSTEM ENCORE ORTHOPEDICS, INC. 510(k) NO: K991790(TRADITIONAL) ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-834-6237 9800 METRIC BLVD. SE DECISION MADE: 06-AUG-99 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTIMAX HAIG II NAIL SYSTEM ENCORE ORTHOPEDICS, INC. 510(k) NO: K991889(TRADITIONAL) ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-834-6237 9800 METRIC BLVD. SE DECISION MADE: 12-AUG-99 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENCORE FULLY COATED HIP ENCORE ORTHOPEDICS, INC. 510(k) NO: K992109(TRADITIONAL) ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-834-6237 9800 METRIC BLVD. SE DECISION MADE: 12-AUG-99 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOSCOPIC SPINAL ACCESS SYSTEM ENDIUS INC. 510(k) NO: K991794(TRADITIONAL) ATTN: SUSAN FINNERAN PHONE NO : 508-643-0983 23 WEST BACON ST. SE DECISION MADE: 13-AUG-99 PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOSONICS TRAK BACK DEVICE ENDOSONICS CORP. 510(k) NO: K990271(TRADITIONAL) ATTN: RICHARD HEBERT PHONE NO : 916-638-8008 2870 KILGORE RD. SE DECISION MADE: 30-AUG-99 RANCHO CORDOVA, CA 95670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED LX-20 CO2 LASER SYSTEM FAMILY, LX-20SA ESC MEDICAL SYSTEMS, INC. 510(k) NO: K991628(TRADITIONAL) ATTN: ZVI LADIN PHONE NO : 972 495 99000 YOKNEAM INDUSTRIAL PARK SE DECISION MADE: 09-AUG-99 PO BOX 240 510(k) SUMMARY AVAILABLE FROM FDA YOKNEAM, ISRAEL 20692 DEVICE: MODIFICATION OF PROMPT L-POP ESPE DENTAL AG 510(k) NO: K992048(TRADITIONAL) ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395 ESPE PLATZ SE DECISION MADE: 16-AUG-99 SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAMMOTOME HH HAND-HELD PROBE, VACUUM SET, CONTROL MODULE, HH HAN ETHICON ENDO-SURGERY, INC. 510(k) NO: K991980(TRADITIONAL) ATTN: TAMIMA ITANI PHONE NO : 513-483-8205 4545 CREEK RD. SE DECISION MADE: 17-AUG-99 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THIN EUROMED, INC. 510(k) NO: K992363(SPECIAL) ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 12-AUG-99 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1) EXCEL TECH. LTD. 510(k) NO: K991903(TRADITIONAL) ATTN: JOHN R MUMFORD PHONE NO : 905 829 5300 2892 PORTLAND DR. SE DECISION MADE: 04-AUG-99 OAKVILLE, ONTARIO, CANADA L6H 5W8510(k) STATEMENT DEVICE: XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16 EXCEL TECH. LTD. 510(k) NO: K992313(TRADITIONAL) ATTN: JOHN R MUMFORD PHONE NO : 905 829 5300 2892 PORTLAND DR. SE DECISION MADE: 19-AUG-99 OAKVILLE, ONTARIO, CANADA L6H 5W8510(k) STATEMENT DEVICE: FERRIS POLYOSTOMY STERILE WOUND DRESSING FERRIS MFG. CORP. 510(k) NO: K991729(TRADITIONAL) ATTN: THEODORE THORSEN PHONE NO : 630-887-9797 16 WEST 300 83RD ST. SE DECISION MADE: 27-AUG-99 BURR RIDGE, IL 60521 510(k) STATEMENT DEVICE: FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES FIBER IMAGING TECHNOLOGIES, INC. 510(k) NO: K992040(TRADITIONAL) ATTN: JOSEPH RESS PHONE NO : 617-965-7714 45 PONTIAC ROAD SE DECISION MADE: 06-AUG-99 NEWTON, MA 02468 510(k) STATEMENT DEVICE: FOTONA NOVALIS ER: YAG LASER SYSTEM FOTONA D.D. 510(k) NO: K991632(TRADITIONAL) ATTN: MOJCA VALIJAVEC PHONE NO : 386 611 511215 STEGNE 7, SE DECISION MADE: 10-AUG-99 LJUBLJANA, SLOVENIA 1210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOTONA NOVALIS R RUBY LASER SYSTEM FOTONA D.D. 510(k) NO: K991634(TRADITIONAL) ATTN: MOJCA VALIJAVEC PHONE NO : 386 611 511215 STEGNE 7, SE DECISION MADE: 10-AUG-99 LJUBLJANA, SLOVENIA 1210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODI FRESENIUS USA, INC. 510(k) NO: K992275(SPECIAL) ATTN: VIRGINIA SINGER PHONE NO : 925-688-0990 110 MASON CR SE DECISION MADE: 04-AUG-99 CONCORD, CA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE FURLONG INDUSTRIES 510(k) NO: K991757(TRADITIONAL) ATTN: PETE FURLONG PHONE NO : 847-548-6831 311 N. SLUSSER STREET SE DECISION MADE: 12-AUG-99 GRAYSLAKE, IL 60030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLE GALLINI U.S., LLC 510(k) NO: K992499(TRADITIONAL) ATTN: PAUL L HAWTHORNE PHONE NO : 800-281-0908 3991 GLENSIDE DR., SUITE F SE DECISION MADE: 12-AUG-99 RICHMOND, VA 23229 510(k) STATEMENT DEVICE: CHOLESITE TEST SYSTEM GDS TECHNOLOGY, INC. 510(k) NO: K992132(TRADITIONAL) ATTN: KEITH CRAWFORD PHONE NO : 219-264-7384 25235 LEER DR. SE DECISION MADE: 20-AUG-99 ELKHART, IN 46514 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6 GE MARQUETTE MEDICAL SYSTEMS, INC.510(k) NO: K991735(TRADITIONAL) ATTN: DAVID WAHLIG PHONE NO : 414-362-2090 8200 WEST TOWER AVE. SE DECISION MADE: 19-AUG-99 MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR GE MARQUETTE MEDICAL SYSTEMS, INC.510(k) NO: K991739(TRADITIONAL) ATTN: MARIA VITUG FOUTS PHONE NO : 800-851-6525 200 HARRY S. TRUMAN, PARKWAY SE DECISION MADE: 19-AUG-99 SUITE 220 510(k) SUMMARY AVAILABLE FROM FDA ANNAPOLIS, MD 21401 DEVICE: GE VIEW APPLICATIONS (CONSISTING OF GE VIEWING STATION AND GE EX GE MEDICAL SYSTEMS, INC. 510(k) NO: K991629(TRADITIONAL) ATTN: LARRY KROGER PHONE NO : 414-544-3894 P.O. BOX 414 SE DECISION MADE: 02-AUG-99 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEIGER ELECTROSURGICAL HANDPIECE SHEATH, MODEL 405 GEIGER MEDICAL TECHNOLOGIES, INC. 510(k) NO: K992149(TRADITIONAL) ATTN: JOHN BOTTJER PHONE NO : 949-240-7584 24040 CAMINO DEL AVION, A-195 SE DECISION MADE: 19-AUG-99 MONARCH BEACH, CA 92629 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEM GENERAL ELECTRIC MEDICAL SYSTEMS 510(k) NO: K992066(TRADITIONAL) ATTN: LARRY A KROGER PHONE NO : 414-544-3894 3000 N GRANDVIEW BLVD SE DECISION MADE: 30-AUG-99 WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES GENERAL GLOVES CORP. 510(k) NO: K992107(TRADITIONAL) ATTN: DAVID HU PHONE NO : 510-732-9623 3423 INVESTMENT BLVD SE DECISION MADE: 23-AUG-99 SUITE 12 510(k) SUMMARY AVAILABLE FROM FDA HAYWARD, CA 94545 DEVICE: GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE GENTELL 510(k) NO: K990440(TRADITIONAL) ATTN: MARK L ITZKOFF PHONE NO : 202-776-7800 1667 K ST. N.W., SUITE 700 SE DECISION MADE: 12-AUG-99 WASHINGTON, DC 20006-1608 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JETSONIC 2000 GREEN RIVER, INC. 510(k) NO: K990545(TRADITIONAL) ATTN: CESAR CORAL PHONE NO : 954-733-4300 5101 N.W. 21ST AVE., SUITE 141 SE DECISION MADE: 11-AUG-99 FORT LAUDERDALE, FL 33309 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KANGNIAN BRAND ACUPUNCTURE NEEDLE HELIO MEDICAL SUPPLIES, INC. 510(k) NO: K991507(TRADITIONAL) ATTN: YI-FEN CHANG PHONE NO : 408-748-9585 2080A WALSH AVE. SE DECISION MADE: 27-AUG-99 SANTA CLARA, CA 95050 510(k) STATEMENT DEVICE: ACUMASTER BRAND ACUPUNCTURE NEEDLE HELIO MEDICAL SUPPLIES, INC. 510(k) NO: K991508(TRADITIONAL) ATTN: YI-FEN CHANG PHONE NO : 408-748-9585 2080A WALSH AVE. SE DECISION MADE: 27-AUG-99 SANTA CLARA, CA 95050 510(k) STATEMENT DEVICE: VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT HEMAGEN DIAGNOSTICS, INC. 510(k) NO: K992224(TRADITIONAL) ATTN: JOSEPH M CALIFANO PHONE NO : 781-890-3766 40 BEAR HILL ROAD SE DECISION MADE: 30-AUG-99 WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT HEMAGEN DIAGNOSTICS, INC. 510(k) NO: K992241(TRADITIONAL) ATTN: JOSEPH M CALIFANO PHONE NO : 781-890-3766 40 BEAR HILL ROAD SE DECISION MADE: 30-AUG-99 WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT HEMAGEN DIAGNOSTICS, INC. 510(k) NO: K992243(TRADITIONAL) ATTN: JOSEPH M CALIFANO PHONE NO : 781-890-3766 40 BEAR HILL ROAD SE DECISION MADE: 30-AUG-99 WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT HEMOCLEANSE, INC. 510(k) NO: K984546(TRADITIONAL) ATTN: STEPHEN R ASH PHONE NO : 765-463-9540 2700 KENT AVE. SE DECISION MADE: 13-AUG-99 WEST LAFAYETTE, IN 47906 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M350 HEWLETT-PACKARD CO. 510(k) NO: K991871(TRADITIONAL) ATTN: WARREN R WALTERS PHONE NO : 515-244-1212 2500 BELL AVE. SE DECISION MADE: 05-AUG-99 DES MOINES, IA 50321 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A HEWLETT-PACKARD CO. 510(k) NO: K992636(SPECIAL) ATTN: MIKE HUDON PHONE NO : 978-659-3173 3000 MINUTEMAN RD. SE DECISION MADE: 31-AUG-99 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K991055(TRADITIONAL) ATTN: MARYBETH NAUGHTON PHONE NO : 201-934-4376 59 ROUTE 17 SE DECISION MADE: 27-AUG-99 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING HOWMEDICA OSTEONICS CORP. 510(k) NO: K992025(TRADITIONAL) ATTN: MARYBETH NAUGHTON PHONE NO : 201-934-4376 59 ROUTE 17 SE DECISION MADE: 13-AUG-99 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KINEMATIC II ROTATING HINGE KNEE HOWMEDICA OSTEONICS CORP. 510(k) NO: K992346(SPECIAL) ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187 59 ROUTE 17 SE DECISION MADE: 12-AUG-99 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEONICS UNIVERSAL DISTAL CEMENT PLUG HOWMEDICA OSTEONICS CORP. 510(k) NO: K992462(TRADITIONAL) ATTN: KATE SUTTON PHONE NO : 201-934-4386 59 ROUTE 17 SE DECISION MADE: 13-AUG-99 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASY-CURE (CURING AND WHITENING LIGHT) ICS OF NORTH AMERICA, INC. 510(k) NO: K992357(TRADITIONAL) ATTN: ALAN A CREAMER PHONE NO : 619-558-9203 10054 MESA RIDGE CT. SE DECISION MADE: 30-AUG-99 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REMOTE INTRODUCER, MODEL PI-1000 IMAGE-GUIDED NEUROLOGICS, INC. 510(k) NO: K990907(TRADITIONAL) ATTN: MICHAEL J RENNER PHONE NO : 407-757-8990 2290 EAU GALLIE BLVD SE DECISION MADE: 12-AUG-99 MELBOURNE, FL 32935 510(k) STATEMENT DEVICE: NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXX IMAGE-GUIDED NEUROLOGICS, INC. 510(k) NO: K992304(TRADITIONAL) ATTN: MICHAEL J RENNER PHONE NO : 407-757-8990 2290 EAU GALLIE BLVD. SE DECISION MADE: 27-AUG-99 MELBOURNE, FL 32935 510(k) STATEMENT DEVICE: INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT) INDUS MEDICARE LTD. 510(k) NO: K992438(ABBREVIATED) ATTN: P.K. REDDY PHONE NO : 91 407 760241 144, S.P. RD., BEGUMPET SE DECISION MADE: 02-AUG-99 HYDERABAD ANDHRA PRADESH, INDIA 50510(k) STATEMENT DEVICE: REPOSE BONE SCREW SYSTEM INFLUENCE, INC. 510(k) NO: K981677(TRADITIONAL) ATTN: JONATHAN S KAHAN, ESQ. PHONE NO : 202-637-5794 555 THIRTEENTH STREET, N.W. SE DECISION MADE: 27-AUG-99 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBE INFLUENCE, INC. 510(k) NO: K991792(TRADITIONAL) ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH STREET, N.W. SE DECISION MADE: 12-AUG-99 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INNERDYNE RADIALLY EXPANDING DILATION, "RED" DEVICE INNERDYNE, INC. 510(k) NO: K990854(TRADITIONAL) ATTN: RICK GAYKOWSKI PHONE NO : 801-350-3600 5060 WEST AMELIA EARHART DR. SE DECISION MADE: 02-AUG-99 SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MACMED PAEDIATRIC INTRAMEDULLARY NAIL INNERVISION, INC. 510(k) NO: K991877(TRADITIONAL) ATTN: FRANK M LEWIS PHONE NO : 901-682-0417 6258 SHADY GROVE RD. EAST SE DECISION MADE: 06-AUG-99 MEMPHIS, TN 38120 510(k) STATEMENT DEVICE: CAPHOSOL ARTIFICIAL SALIVA INPHARMA A.S. 510(k) NO: K991938(TRADITIONAL) ATTN: BRUCE R MANNING PHONE NO : 508-393-3100 P.O. BOX 809, 27 SOUTH STREET SE DECISION MADE: 10-AUG-99 NORTHBOROUGH, MA 01532 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROTOSNARE INSCOPE, LLC 510(k) NO: K992477(TRADITIONAL) ATTN: AL WEISENBORN PHONE NO : 305-829-3437 19526 EAST LAKE DRIVE SE DECISION MADE: 24-AUG-99 MIAMI, FL 33015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VEN INSTRUMENTATION INDUSTRIES, INC. 510(k) NO: K991785(TRADITIONAL) ATTN: TRICIA WOOD PHONE NO : 412-854-1133 2990 INDUSTRIAL BLVD. SE DECISION MADE: 17-AUG-99 BETHEL PARK, PA 15102 510(k) STATEMENT DEVICE: TSX PROBE, OCULAR CONTACT PROBE;TSX PROBE,OCULAR CONTACT PROBE,S INSTRUMENTS FOR MEDICINE AND DIAGN510(k) NO: K992508(TRADITIONAL) ATTN: TRACY S BEST PHONE NO : 801-972-0500 3959 WEST 1820 SOUTH SE DECISION MADE: 19-AUG-99 SALT LAKE CITY, UT 84104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33 INTEGRA NEUROCARE LLC 510(k) NO: K992006(TRADITIONAL) ATTN: NANCY A MATHEWSON PHONE NO : 858-455-1115 5955 PACIFIC CENTER BLVD. SE DECISION MADE: 17-AUG-99 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEOPLAST, MODEL POP200 INTERPORE CROSS INTL. 510(k) NO: K991854(TRADITIONAL) ATTN: LYNN RODARTI PHONE NO : 949-453-3200 181 TECHNOLOGY DR. SE DECISION MADE: 26-AUG-99 IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRASTENT INTRATHERAPEUTICS, INC. 510(k) NO: K991929(SPECIAL) ATTN: CATHY YOHNK PHONE NO : 612-697-2003 651 CAMPUS DR. SE DECISION MADE: 04-AUG-99 ST. PAUL, MN 55112-3495 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IRL VASOSCAN(TM) INTRAVASCULAR ULTRASOUND CATHETER INTRAVASCULAR RESEARCH LTD. 510(k) NO: K982208(TRADITIONAL) ATTN: LOUISE C MYERS PHONE NO : 425-867-0892 14808 N.E. 66TH STREET SE DECISION MADE: 27-AUG-99 REDMOND, WA 98052-4712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TILT/RECLINER FOR POWER WHEELCHAIRS, MODEL 2G INVACARE CORP. 510(k) NO: K991119(TRADITIONAL) ATTN: EDWARD A KROLL PHONE NO : 440-329-6595 1200 TAYLOR ST. SE DECISION MADE: 19-AUG-99 ELYRIA, OH 44035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODELS LYNX AND PANTHER MOTORIZED SCOOTERS INVACARE CORP. 510(k) NO: K992052(TRADITIONAL) ATTN: EDWARD A KROLL PHONE NO : 440-329-6595 ONE INVACARE WAY SE DECISION MADE: 12-AUG-99 P.O. BOX 4028 510(k) SUMMARY AVAILABLE FROM FDA ELYRIA, OH 44036-2125 DEVICE: TROCAR & TROCAR SLEEVES, LAPAROSCOPES, LAPAROSCOPIC FORCEPS, & L JAKOUBEK MEDIZINTECHNIK GMBH 510(k) NO: K990785(TRADITIONAL) ATTN: DOUGLAS HULFISH PHONE NO : 847-670-8293 1822 N. STRATFORD RD. SE DECISION MADE: 27-AUG-99 ARLINGTON HTS., IL 60004 510(k) STATEMENT DEVICE: JMS A. V. FISTULA NEEDLE SET JMS CO., LTD. 510(k) NO: K990470(TRADITIONAL) ATTN: TETSUHARU HIROSE PHONE NO : 818 224 35806 12-17, KAKO-MACHI, NAKA-KU SE DECISION MADE: 30-AUG-99 HIROSHIMA, JAPAN 730-8652 510(k) STATEMENT DEVICE: JMS APHERESIS NEEDLE JMS CO., LTD. 510(k) NO: K990510(TRADITIONAL) ATTN: TETSUHARU HIROSE PHONE NO : 81 82 2435806 12-17, KAKO-MACHI, NAKA-KU SE DECISION MADE: 30-AUG-99 HIROSHIMA, JAPAN 730-8652 510(k) STATEMENT DEVICE: MODIFICATION OF JMS NEEDLES AND JMS SYRINGES JMS CO., LTD. 510(k) NO: K991904(TRADITIONAL) ATTN: KEISUKE URATOMI PHONE NO : 818 224 35806 12,17,KAKO-MACHI,NAKA-KU SE DECISION MADE: 31-AUG-99 HIROSHIMA, 730, JAPAN 510(k) STATEMENT DEVICE: MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, JOHNSON & JOHNSON MEDICAL, DIV. OF510(k) NO: K990236(TRADITIONAL) ATTN: LINDA G HILL PHONE NO : 817-262-4791 2500 EAST ARBROOK BLVD. SE DECISION MADE: 20-AUG-99 ARLINGTON, TX 76014-3631 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JOSTRA HL-20 TWIN PUMP JOSTRA USA 510(k) NO: K984338(TRADITIONAL) ATTN: KATHY JOHNSON PHONE NO : 877-567-8722 478 MEDIA ROAD SE DECISION MADE: 19-AUG-99 OXFORD, PA 19363 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KSEA CALCUSPLIT KARL STORZ ENDOSCOPY 510(k) NO: K992114(TRADITIONAL) ATTN: KEVIN A KENNAN PHONE NO : 310-338-8100 600 CORPORATE POINTE SE DECISION MADE: 18-AUG-99 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAPAROCAM KARL STORZ ENDOSCOPY 510(k) NO: K992541(TRADITIONAL) ATTN: KEVIN KENNAN PHONE NO : 310-410-2769 600 CORPORATE POINTE SE DECISION MADE: 19-AUG-99 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60 KATECHO, INC. 510(k) NO: K991007(TRADITIONAL) ATTN: LORNE SCHARNBERG PHONE NO : 515-244-1212 2500 BELL AVE. SE DECISION MADE: 23-AUG-99 DES MOINES, IA 50321 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL VIDEO RECORDING SYSTEM KAY ELEMETRICS CORP. 510(k) NO: K991738(TRADITIONAL) ATTN: WILLIAM D HARBESON PHONE NO : 973-628-6200 2 BRIDGEWATER LN. SE DECISION MADE: 13-AUG-99 LINCOLN PARK, NJ 07035-1488 510(k) STATEMENT DEVICE: KELLER VITAL SIGNS MONITOR, KMS 890+ KELLER MEDICAL SPECIALTIES PRODUCT510(k) NO: K990648(TRADITIONAL) ATTN: JEAN WAGNER PHONE NO : 847-395-3547 42609 CRAWFORD RD SE DECISION MADE: 10-AUG-99 ANTIOCH, IL 60002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BELLEGLAZE KERR DENTAL MATERIALS CENTER 510(k) NO: K992067(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVE. SE DECISION MADE: 27-AUG-99 ORANGE, CA 92667 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT KIEL LABORATORIES, INC. 510(k) NO: K991958(TRADITIONAL) ATTN: TANYJA PORCHA PHONE NO : 770-534-0079 2225 CENTENNIAL DRIVE SE DECISION MADE: 13-AUG-99 GAINESVILLE, GA 30504 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KMI WRIST FUSION SYSTEM KINETIKOS MEDICAL, INC. 510(k) NO: K991873(TRADITIONAL) ATTN: MICHAEL COLLINS PHONE NO : 619-558-2233 4115 SORRENTO VALLEY BLVD. SE DECISION MADE: 17-AUG-99 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: K-L-W INTRAORAL DISTRACTOR KLS-MARTIN L.P. 510(k) NO: K991875(TRADITIONAL) ATTN: ED RANSOM PHONE NO : 813-376-4154 3234 ELLA LANE SE DECISION MADE: 18-AUG-99 NEW PORT RICHEY, FL 34655 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KONICA DIRECT DIGITIZER, MODEL DD-341 KONICA CORP. 510(k) NO: K990359(TRADITIONAL) ATTN: RUSSELL D MUNVES PHONE NO : 212-490-4100 THE CHRYSLER BUILDING SE DECISION MADE: 17-AUG-99 405 LEXINGTON AVENUE 510(k) STATEMENT NEW YORK, NY 10174 DEVICE: POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORE KOSSAN LATEX INDUSTRIES (M) SDN. B510(k) NO: K992496(TRADITIONAL) ATTN: LIM KWAN HWA PHONE NO : 603 392 7616 LOT 16632, 5-1/4 MILES, SE DECISION MADE: 25-AUG-99 JALAN MERU 510(k) STATEMENT KELANG, SELANGOR, MALAYSIA 41050 DEVICE: POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) KOSSAN LATEX INDUSTRIES (M) SDN. B510(k) NO: K992497(TRADITIONAL) ATTN: LIM KWAN HWA PHONE NO : 603 392 7616 LOT 16632, 5-1/4 MILES, SE DECISION MADE: 25-AUG-99 JALAN MERU 510(k) STATEMENT KELANG, SELANGOR, MALAYSIA 41050 DEVICE: KRONUS OPTIQUANT THYROGLOBULIN KIT KRONUS MARKET DEVELOPMENT ASSOCIAT510(k) NO: K991720(TRADITIONAL) ATTN: A.P. DOERSCCHUK PHONE NO : 800-822-6999 1000 CALLE AMANECER SE DECISION MADE: 09-AUG-99 SAN CLEMENTE, CA 92673 510(k) STATEMENT DEVICE: THERADYNE ROVER POWERED WHEELCHAIR KURT MFG. CO. 510(k) NO: K982724(ABBREVIATED) ATTN: PHIL SCHLANGEN PHONE NO : 612-623-4047 1325 QUINCY STREET N.E. SE DECISION MADE: 12-AUG-99 MINNEAPOLIS, MN 55413 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UROSTYM BIOFEEDBACK AND STIMULATION PROBES LABORIE MEDICAL TECH CORP. 510(k) NO: K990041(TRADITIONAL) ATTN: DALE COLEMAN PHONE NO : 802-878-1110 310 HURRICANE LANE #2 SE DECISION MADE: 05-AUG-99 WILLISTON, VT 05495 510(k) STATEMENT DEVICE: LAGLOVE BRAND BLUE COLOLRED NITRILE EXAMINATION GLOVE (POWDERED) LAGLOVE (M) SDN. BHD. 510(k) NO: K990883(TRADITIONAL) ATTN: G. BASKARAN PHONE NO : 603 833 5054 JALAN SIMPANG BALAK, OFF BATU SE DECISION MADE: 10-AUG-99 13, JALAN CHERAS, 43000 KAJANG 510(k) STATEMENT SELANGOR DARUL EHSAN MALA, MADAGASCAR DEVICE: LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDERED) LAGLOVE (M) SDN. BHD. 510(k) NO: K991949(TRADITIONAL) ATTN: G. BASKARAN PHONE NO : 603 833 5054 JALAN SIMPANG BALAK, OFF BATU SE DECISION MADE: 12-AUG-99 13, JALAN CHERAS, 43000 KAJANG 510(k) STATEMENT SELANGOR DARUL EHSAN MALA, MADAGASCAR DEVICE: LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDER-FREE) LAGLOVE (M) SDN. BHD. 510(k) NO: K991950(TRADITIONAL) ATTN: G. BASKARAN PHONE NO : 603 833 35411 JALAN SIMPANG BALAK, OFF BATU SE DECISION MADE: 12-AUG-99 13, JALAN CHERAS, 43000 KAJANG 510(k) STATEMENT SELANGOR DARUL EHSAN MALA, MADAGASCAR DEVICE: LAGLOVE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT L LAGLOVE (M) SDN. BHD. 510(k) NO: K992019(TRADITIONAL) ATTN: G. BASKARAN PHONE NO : 603 833 5411 LOT 478, JALAN SIMPANG BALAK, SE DECISION MADE: 05-AUG-99 OFF BATU 13, JALAN CHERAS 510(k) STATEMENT KAJANG, SELANGOR, D.E., MALAYSIA 43000 DEVICE: PARAGON LANCER ORTHODONTICS, INC. 510(k) NO: K991481(TRADITIONAL) ATTN: DOUGLAS D MILLER PHONE NO : 760-744-5585 253 PAWNEE ST. SE DECISION MADE: 11-AUG-99 SAN MARCOS, CA 92069 510(k) STATEMENT DEVICE: LYRA SERIES SURGICAL SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGUR LASERSCOPE 510(k) NO: K990903(TRADITIONAL) ATTN: PAUL HARDIMAN PHONE NO : 408-943-0636 3052 ORCHARD DR. SE DECISION MADE: 27-AUG-99 SAN JOSE, CA 95134-2011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: B2C HIP SYSTEM LEPINE GROUPE SPA. 510(k) NO: K992490(TRADITIONAL) ATTN: DOUGLAS W STUART PHONE NO : 941-366-1882 962 SOUTH TAMIAMI, STE. 203 SE DECISION MADE: 19-AUG-99 SARASOTA, FL 34326 510(k) STATEMENT DEVICE: SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING LIBRARY MEDICAL INC. 510(k) NO: K991312(TRADITIONAL) ATTN: RICHARD A HARTMAN PHONE NO : 800-711-8055 60 TERENCE DR. SE DECISION MADE: 20-AUG-99 PITTSBURGH, PA 15236 510(k) STATEMENT DEVICE: TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVOR LINE ONE LABORATORIES 510(k) NO: K991892(TRADITIONAL) ATTN: ROBERT GRUBER PHONE NO : 323-264-8887 1481 EAST 4TH ST. SE DECISION MADE: 19-AUG-99 LOS ANGELES, CA 90033 510(k) STATEMENT DEVICE: BIOSTINGER-V BIOABSORBABLE MENISCAL REPAIR DEVICE LINVATEC CORP. 510(k) NO: K991715(TRADITIONAL) ATTN: LAURA SENEFF PHONE NO : 727-399-5234 11311 CONCEPT BLVD. SE DECISION MADE: 06-AUG-99 LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPSULAR SHRINKAGE ELECTRODE LINVATEC CORP. 510(k) NO: K991830(TRADITIONAL) ATTN: LAURA SENEFF PHONE NO : 727-392-6464 11311 CONCEPT BLVD. SE DECISION MADE: 20-AUG-99 LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUMA LIGHT 2000 CURE LIGHT LUMA LITE, INC, 510(k) NO: K992102(TRADITIONAL) ATTN: JOSEPH FOREHAND PHONE NO : 619-318-1251 477 MARINA PARKWAY #400 SE DECISION MADE: 31-AUG-99 CHULA VISTA, CA 91910 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUET II GLUCOSE CONTROL MONITORING SYSTEM LXN CORP. 510(k) NO: K990942(TRADITIONAL) ATTN: NEDA RASHTI PHONE NO : 619-546-7500 6325 LUSK BLVD. SE DECISION MADE: 02-AUG-99 SAN DIEGO, CA 92121 510(k) STATEMENT DEVICE: LYSTA LC COMPACTA CURING LIGHT, MODELS LC 2500 COMPACTA, LC 4000 LYSTA A/S 510(k) NO: K992236(TRADITIONAL) ATTN: GREGERS LYSTAGER PHONE NO : 454 495 3000 GAMMELGAARDSVEJ 102 SE DECISION MADE: 27-AUG-99 FARUM, DENMARK DK-3520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGNATEK 30 MAGNA ADVANCED TECHNOLOGIES, INC. 510(k) NO: K991819(TRADITIONAL) ATTN: ANNIE VELEZ PHONE NO : 305-261-2211 7200 N.W. SEVENTH STREET SE DECISION MADE: 19-AUG-99 MIAMI, FL 33126 510(k) STATEMENT DEVICE: MAHE INSTRUMENTS MAHE INTL., INC. 510(k) NO: K991426(TRADITIONAL) ATTN: WINIFRIED REICH PHONE NO : 615-385-3545 300 JAMES ROBERTSON PKWY. SE DECISION MADE: 05-AUG-99 NASHVILLE, TN 37201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MANUAL WHEELCHAIR MAJOR MOBILITY PRODUCTS, INC. 510(k) NO: K992035(TRADITIONAL) ATTN: SCOTT SCHWEISS PHONE NO : 281-398-5444 18206 MANCE CT. SE DECISION MADE: 12-AUG-99 HOUSTON, TX 77094 510(k) STATEMENT DEVICE: HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR MEDIC-AID LTD. 510(k) NO: K991685(TRADITIONAL) ATTN: PAUL E DRYDEN PHONE NO : 317-335-3780 6329 W. WATERVIEW CT. SE DECISION MADE: 13-AUG-99 MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUADRATURE LOWER EXTREMITY COIL, MODEL 473PH-64 MEDICAL ADVANCES, INC. 510(k) NO: K991724(TRADITIONAL) ATTN: THOMAS E TYNES PHONE NO : 414-258-3808 10437 INNOVATION DR. SE DECISION MADE: 02-AUG-99 MILWAUKEE, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K992430(TRADITIONAL) ATTN: SCOT D KINGHORN PHONE NO : 800-582-3095 542 FLYNN RD. SE DECISION MADE: 30-AUG-99 CAMARILLO, CA 93012 510(k) STATEMENT DEVICE: ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR MEDICAL DATA ELECTRONICS, INC. 510(k) NO: K992411(SPECIAL) ATTN: DAVID M TRUEBLOOD PHONE NO : 818-768-6411 12720 WENTWORTH ST. SE DECISION MADE: 18-AUG-99 ARLETA, CA 91331 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR MEDICAL DATA ELECTRONICS, INC. 510(k) NO: K992413(SPECIAL) ATTN: DAVID M TRUEBLOOD PHONE NO : 818-768-6411 12720 WENTWORTH ST. SE DECISION MADE: 19-AUG-99 ARLETA, CA 91331 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDIFIX INC. MEDIFIX INC. 510(k) NO: K992483(TRADITIONAL) ATTN: GEORGE ALBULESCU PHONE NO : 847-965-1898 8727 NARRAGANSETT SE DECISION MADE: 30-AUG-99 MORTON GROVE, IL 60053-0000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EPISTAR/EPISTAR CSE SPINAL/EPIDURAL ANESTHESIA ADMINISTRATION SE MEDIMEX HOLFELD GMBH & CO. 510(k) NO: K991719(TRADITIONAL) ATTN: DONALD F GRABARZ PHONE NO : 801-233-0075 MID VALLEY PROFESSIONAL PLAZA SE DECISION MADE: 18-AUG-99 SALT LAKE CITY, UT 84047-7101 510(k) STATEMENT DEVICE: MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD MEDLINE INDUSTRIES, INC. 510(k) NO: K991559(TRADITIONAL) ATTN: LARA N SIMMONS PHONE NO : 847-949-2639 ONE MEDLINE PL. SE DECISION MADE: 23-AUG-99 MUNDELEIN, IL 60060-4486 510(k) STATEMENT DEVICE: MEDTRONIC AVE BRIDGE STENT MEDTRONIC AVE, INC. 510(k) NO: K992318(SPECIAL) ATTN: SUSAN WALTON PHONE NO : 707-591-7315 2330A CIRCADIAN WAY SE DECISION MADE: 02-AUG-99 SANTA ROSA, CA 95407-5415 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRONIC AVE BRIDGE STENT MEDTRONIC AVE, INC. 510(k) NO: K992569(SPECIAL) ATTN: SUSAN WALTON PHONE NO : 707-591-7315 2330A CIRCADIAN WAY SE DECISION MADE: 31-AUG-99 SANTA ROSA, CA 95407-5415 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMUNOCARD STAT! E. COLI O157:H7 MERIDIAN DIAGNOSTICS, INC. 510(k) NO: K990263(TRADITIONAL) ATTN: ALLEN D NICKOL PHONE NO : 513-271-3700 3471 RIVER HILLS DR. SE DECISION MADE: 09-AUG-99 CINCINNATI, OH 45244 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE METRIKA, INC. 510(k) NO: K984530(TRADITIONAL) ATTN: ERIKA B AMMIRATI PHONE NO : 650-949-2768 575 SHIRLYNN COURT SE DECISION MADE: 10-AUG-99 LOS ALTOS, CA 94022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNA TORQ TORQUE WRENCH, TORQUE WRENCH MICRO MOTORS, INC. 510(k) NO: K991283(TRADITIONAL) ATTN: KAREN U SALINAS PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 18-AUG-99 IRVINE, CA 92606-1849 510(k) STATEMENT DEVICE: EQUINOX OCCLUSION BALLOON SYSTEM MICRO THERAPEUTICS, INC. 510(k) NO: K990487(TRADITIONAL) ATTN: TOM DAUGHTERS PHONE NO : 949-837-3700 2 GOODYEAR SE DECISION MADE: 31-AUG-99 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICRO-STRIP FOR PHENCYCLIDINE METABOLITES MICRODIAGNOSTICS, INC. 510(k) NO: K991505(TRADITIONAL) ATTN: ROY CHUNG PHONE NO : 714-347-0307 28062 FORBES ROAD, SUITE B SE DECISION MADE: 05-AUG-99 LAGUNA NIGUEL, CA 92677 510(k) STATEMENT DEVICE: MICRO-STRIP FOR MARIJUANA METABOLITES MICRODIAGNOSTICS, INC. 510(k) NO: K991516(TRADITIONAL) ATTN: ROY CHUNG PHONE NO : 949-347-0307 28062 FORBES ROAD, SUITE B SE DECISION MADE: 05-AUG-99 LAGUNA NIGUEL, CA 92677 510(k) STATEMENT DEVICE: SILVERSTEIN MICROWICK MICROMEDICS, INC. 510(k) NO: K991670(TRADITIONAL) ATTN: CHARLES GROTE PHONE NO : 651-452-1977 1285 CORPORATE CENTER DR., SE DECISION MADE: 26-AUG-99 #150 510(k) STATEMENT EAGAN, MN 55121 DEVICE: MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCES MICROMEDICS, INC. 510(k) NO: K992138(TRADITIONAL) ATTN: CHARLES GROTE PHONE NO : 651-452-1977 1285 CORPORATE CENTER DR., SE DECISION MADE: 09-AUG-99 #150 510(k) STATEMENT EAGAN, MN 55121 DEVICE: RENACLEAR DIALYZER CLEANING SYSTEM MINNTECH CORP. 510(k) NO: K991851(TRADITIONAL) ATTN: RICHARD M ORMSBEE PHONE NO : 612-551-2689 14605 28TH AVE. NORTH SE DECISION MADE: 30-AUG-99 MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MITAKA POINT SETTER MITAKA USA, INC. 510(k) NO: K991989(TRADITIONAL) ATTN: MAX STURGIS PHONE NO : 435-649-2236 2337 LUCKY JOHN DRIVE SE DECISION MADE: 27-AUG-99 PARK CITY, UT 84060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VAPR 2.3MM END EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM MITEK PRODUCTS 510(k) NO: K992406(SPECIAL) ATTN: PAULA E BULGER PHONE NO : 781-251-2746 60 GLACIER DR. SE DECISION MADE: 06-AUG-99 WESTWOOD, MA 02090 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NORODYN 8000 SEMG SYSTEM, ND-8000 MYOTRONICS-NOROMED, INC. 510(k) NO: K992439(SPECIAL) ATTN: FRAY ADIB PHONE NO : 206-243-4214 15425 53RD AVE. SOUTH SE DECISION MADE: 13-AUG-99 TUKWILA, WA 98188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILGEL STC-S NAGOR LTD. 510(k) NO: K984029(TRADITIONAL) ATTN: J.A. EVANS PHONE NO : 44 016 24625556 PO BOX 21 DOUGLAS SE DECISION MADE: 05-AUG-99 ISLE OF MAN IM99 1AX 510(k) SUMMARY AVAILABLE FROM FDA BRITISH ISLES, BRITISH VIRGIN ISLANDS DEVICE: SUZANNE NELLCOR PURITAN BENNETT, INC. 510(k) NO: K990565(TRADITIONAL) ATTN: DARIN BUSCH PHONE NO : 612-694-3563 2800 NORTHWEST BLVD. SE DECISION MADE: 18-AUG-99 MINNEAPOLIS, MN 55441-2625 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: N-395 PULSE OXIMETER, MODEL N-395 NELLCOR PURITAN BENNETT, INC. 510(k) NO: K991823(TRADITIONAL) ATTN: DAVID A. C. GREEN PHONE NO : 760-603-5978 2200 FARADAY AVE. SE DECISION MADE: 25-AUG-99 CARLSBAD, CA 92008-7208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CUTANEOUS (BAR) ELECTRODE NEURO SUPPLIES, INC. 510(k) NO: K991769(TRADITIONAL) ATTN: RONALD LUICH PHONE NO : 860-442-5650 86 BOSTON POST ROAD SE DECISION MADE: 18-AUG-99 WATERFORD, CT 06385 510(k) STATEMENT DEVICE: CUTANEOUS (GROUND) ELECTRODE NEURO SUPPLIES, INC. 510(k) NO: K991770(TRADITIONAL) ATTN: RONALD LUICH PHONE NO : 860-442-5650 86 BOSTON POST ROAD SE DECISION MADE: 18-AUG-99 WATERFORD, CT 06385 510(k) STATEMENT DEVICE: DIGITAL RING ELECTRDE NEURO SUPPLIES, INC. 510(k) NO: K991771(TRADITIONAL) ATTN: RONALD LUICH PHONE NO : 860-442-5650 86 BOSTON POST ROAD SE DECISION MADE: 18-AUG-99 WATERFORD, CT 06385 510(k) STATEMENT DEVICE: CUTANEOUS (DISC) ELECTRODE NEURO SUPPLIES, INC. 510(k) NO: K991772(TRADITIONAL) ATTN: RONALD LUICH PHONE NO : 860-442-5650 86 BOSTON POST ROAD SE DECISION MADE: 18-AUG-99 WATERFORD, CT 06385 510(k) STATEMENT DEVICE: SOLUSTAPLE NEWDEAL S.A. 510(k) NO: K991566(TRADITIONAL) ATTN: NORMAN F ESTRIN PHONE NO : 301-279-2899 9109 COPENHAVER DRIVE SE DECISION MADE: 03-AUG-99 POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM NIDEK, INC. 510(k) NO: K991284(TRADITIONAL) ATTN: JERRY TSUTSUMI PHONE NO : 510-353-7706 47651 WESTINGHOUSE DR. SE DECISION MADE: 06-AUG-99 FREMONT, CA 94539 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERI NIPRO MEDICAL CORP. 510(k) NO: K991623(TRADITIONAL) ATTN: KAELYN HADLEY PHONE NO : 606-224-8256 1384 COPPERFIELD COURT SE DECISION MADE: 09-AUG-99 LEXINGTON, KY 40514-1268 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NONIN PULSE OXIMETER AND CARBON DIOXIDE DETECTOR, MODELS 9843, 9 NONIN MEDICAL, INC. 510(k) NO: K982969(TRADITIONAL) ATTN: RICHARD P BENNETT PHONE NO : 612-553-9968 2605 FERNBROOK LANE, NORTH SE DECISION MADE: 12-AUG-99 MINNEAPOLIS, MN 55447-4755 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPER PORCELAIN TI-22 NORITAKE CO., INC. 510(k) NO: K992024(TRADITIONAL) ATTN: MARSHA C WERTZBERGER PHONE NO : 202-857-6122 1050 CONNECTICUT AVENUE, N.W. SE DECISION MADE: 27-AUG-99 WASHINGTON, DC 20036-5339 510(k) STATEMENT DEVICE: BURNFREE PAIN RELIEVING GEL, MODEL 4B NORTRADE MEDICAL, INC. 510(k) NO: K990178(TRADITIONAL) ATTN: JAY W TAYLOR PHONE NO : 801-569-9090 9382 SOUTH 670 WEST SE DECISION MADE: 13-AUG-99 SANDY, UT 84070 510(k) STATEMENT DEVICE: BURNFREE 1/8 OZ. STERILE PAIN RELIEVING GEL, MODEL SD NORTRADE MEDICAL, INC. 510(k) NO: K990179(TRADITIONAL) ATTN: JAY W TAYLOR PHONE NO : 801-569-9090 9382 SOUTH 670 WEST SE DECISION MADE: 13-AUG-99 SANDY, UT 84070 510(k) STATEMENT DEVICE: BURNFREE (4"X4", 8"X8", 16"X24") STERILE BURN & WOUND DRESSING NORTRADE MEDICAL, INC. 510(k) NO: K990180(TRADITIONAL) ATTN: JAY W TAYLOR PHONE NO : 801-569-9090 9382 SOUTH 670 WEST SE DECISION MADE: 13-AUG-99 SANDY, UT 84070 510(k) STATEMENT DEVICE: MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD NSK NAKANISHI, INC. 510(k) NO: K991701(TRADITIONAL) ATTN: HIROJI SEKIGUCHI PHONE NO : 028 964 3380 340 KAMIHINATA, KANUMA-SHI SE DECISION MADE: 10-AUG-99 TOCHIGI-KEN, JAPAN 322 510(k) STATEMENT DEVICE: MINI 6800 DIGITAL MOBILE C-ARM OEC MEDICAL SYSTEMS, INC. 510(k) NO: K992506(ABBREVIATED) ATTN: TED L PARROT PHONE NO : 801-328-9300 384 WRIGHT BROTHERS DR. SE DECISION MADE: 19-AUG-99 SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2 OLYMPUS AMERICA, INC. 510(k) NO: K992086(TRADITIONAL) ATTN: LAURA STORMS-TYLER PHONE NO : 516-844-5415 TWO CORPORATE CENTER DR. SE DECISION MADE: 19-AUG-99 MELVILLE, NY 11042-1179 510(k) STATEMENT DEVICE: PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, TURQUOISE,NON-S OMNIGRACE LTD. 510(k) NO: K991845(TRADITIONAL) ATTN: K.C. CHOONG PHONE NO : 667 443 9526 641, MOO5 KANCHANAWANIT ROAD SE DECISION MADE: 05-AUG-99 TAMBON BANPRU 510(k) STATEMENT HAT YAI, SONGKHLA, THAILAND 90250 DEVICE: PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STE OMNIGRACE LTD. 510(k) NO: K991846(TRADITIONAL) ATTN: K.C. CHOONG PHONE NO : 667 443 9526 641, MOO5 KANCHANAWANIT ROAD SE DECISION MADE: 05-AUG-99 TAMBON BANPRU 510(k) STATEMENT HAT YAI, SONGKHLA, THAILAND 90250 DEVICE: RESOLUTION 5X (SPHERICAL) AND ULTRA GEL 5X (TORIC)(HIOXIFILCON A OPTI-CENTRE LABORATORIES 510(k) NO: K992589(TRADITIONAL) ATTN: MARTIN DALSING PHONE NO : 970-243-5490 623 GLACIER DRIVE SE DECISION MADE: 26-AUG-99 GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXPRESSEYE OPTOMOTOR LABORATORIES 510(k) NO: K992473(TRADITIONAL) ATTN: BURKHART FISCHER PHONE NO : 49 741 2922600 TIVOLISTR. 11 SE DECISION MADE: 12-AUG-99 D-79104 FREIBURG, GERMANY D-79104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOF-WATCH S ORGANON TEKNIKA CORP. 510(k) NO: K992596(SPECIAL) ATTN: REBECCA A RIVAS PHONE NO : 919-620-2288 100 AKZO AVE. SE DECISION MADE: 30-AUG-99 DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOF-WATCH SX ORGANON TEKNIKA CORP. 510(k) NO: K992598(SPECIAL) ATTN: REBECCA A RIVAS PHONE NO : 919-620-2288 100 AKZO AVE. SE DECISION MADE: 30-AUG-99 DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I RANGE VERIFIERS ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K992349(TRADITIONAL) ATTN: MARLENE A SHULMAN PHONE NO : 716-453-4041 100 INDIGO CREEK DRIVE SE DECISION MADE: 24-AUG-99 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RLP CHOLESTEROL IMMUNOSEPARATION ASSAY OTSUKA PHARMACEUTICAL CO., LTD. 510(k) NO: K991083(TRADITIONAL) ATTN: JAMES W HARRIS PHONE NO : 301-527-4719 2440 RESEARCH BLVD SE DECISION MADE: 20-AUG-99 ROCKVILLE, MD 20850 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXPLORER 3D OUR SCIENTIFIC INTL., INC. 510(k) NO: K991815(TRADITIONAL) ATTN: MARIO CABALLERO PHONE NO : 925-227-1998 5870 STONERIDGE DRIVE SE DECISION MADE: 13-AUG-99 PLEASANTVILLE, CA 94588 510(k) STATEMENT DEVICE: HEPARIN CONTROL PLASMA LEVEL 1 PACIFIC HEMOSTASIS 510(k) NO: K992278(TRADITIONAL) ATTN: LAURA A WORFOLK PHONE NO : 704-875-0494 11515 VANSTORY DR. SE DECISION MADE: 26-AUG-99 HUNTERSVILLE, NC 28078-8144 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEPARIN CONTROL PLASMA LEVEL 2 PACIFIC HEMOSTASIS 510(k) NO: K992279(TRADITIONAL) ATTN: LAURA A WORFOLK PHONE NO : 704-875-0494 11515 VANSTORY DR. SE DECISION MADE: 26-AUG-99 HUNTERSVILLE, NC 28078-8144 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF PALL MEDICAL 510(k) NO: K992361(TRADITIONAL) ATTN: LEONARD S BERMAN PHONE NO : 516-484-5400 2200 NORTHERN BOULEVARD SE DECISION MADE: 20-AUG-99 EAST HILLS, NY 11548-1209 510(k) STATEMENT DEVICE: HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE LATEX EXAMINATION GLO PAMITEX INDUSTRIES SDN BHD 510(k) NO: K992165(TRADITIONAL) ATTN: SAID AWANG PHONE NO : 606 631 3122 2 1/2 MILES, JALAN RASAH SE DECISION MADE: 25-AUG-99 SEREMBAN, NAGERI SEMBILAN 510(k) STATEMENT DARUL KHUSUS, MALAYSIA 70300 DEVICE: HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION G PAMITEX INDUSTRIES SDN BHD 510(k) NO: K992223(TRADITIONAL) ATTN: SAID AWANG PHONE NO : 606 631 3122 2 1/2 MILES, JALAN RASAH SE DECISION MADE: 30-AUG-99 SEREMBAN, NAGERI SEMBILAN 510(k) STATEMENT DARUL KHUSUS, MALAYSIA 70300 DEVICE: HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED NITRILE EXAMINATION PAMITEX INDUSTRIES SDN BHD 510(k) NO: K992299(TRADITIONAL) ATTN: SAID AWANG PHONE NO : 606 631 3122 2 1/2 MILES, JALAN RASAH SE DECISION MADE: 23-AUG-99 SEREMBAN, NAGERI SEMBILAN 510(k) STATEMENT DARUL KHUSUS, MALAYSIA 70300 DEVICE: CERSR ELECTROMYOGRAPHY SYSTEM PAPASPINAL DIAGNOSTIC CO. 510(k) NO: K990766(TRADITIONAL) ATTN: JOEL S FADEN PHONE NO : 301-881-9139 11605 HITCHING POST LANE SE DECISION MADE: 27-AUG-99 ROCKVILLE, MD 20852 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARALLAX TRACER RADIOPAQUE PARTICLES PARALLAX MEDICAL, INC. 510(k) NO: K991893(TRADITIONAL) ATTN: SUSAN G MARQUES PHONE NO : 650-934-6969 453 RAVENDALE DR., SUITE B SE DECISION MADE: 13-AUG-99 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASCO MIC AND MIC/ID PANELS PASCO LABORATORIES, INC. 510(k) NO: K991925(TRADITIONAL) ATTN: LINDA K DILLON PHONE NO : 800-321-9813 12750 WEST FORTY-SECOND AVENUE SE DECISION MADE: 26-AUG-99 WHEAT RIDGEE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASCO MIC AND MIC/ID PANELS PASCO LABORATORIES, INC. 510(k) NO: K992059(TRADITIONAL) ATTN: LINDA K DILLON PHONE NO : 303-423-9504 12750 WEST 42ND AVE. SE DECISION MADE: 30-AUG-99 WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASCO MIC AND MIC/ID PANELS (CEFUROXIME) PASCO LABORATORIES, INC. 510(k) NO: K992076(TRADITIONAL) ATTN: LINDA K DILLON PHONE NO : 303-432-9504 12750 WEST 42ND AVE. SE DECISION MADE: 30-AUG-99 WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUNNEL TROCAR PATTON MEDICAL CORPORATION 510(k) NO: K992324(TRADITIONAL) ATTN: MICHAEL T PATTON PHONE NO : 512-329-0469 1000 WESTBANK DRIVE SE DECISION MADE: 19-AUG-99 SUITE 5A200 510(k) SUMMARY AVAILABLE FROM FDA AUSTIN, TX 78746 DEVICE: O.B. TAMPON PERSONAL PRODUCTS CO. 510(k) NO: K990536(TRADITIONAL) ATTN: RALPH PETRONE PHONE NO : 908-874-1700 199 GRANDVIEW RD. SE DECISION MADE: 31-AUG-99 SKILLMAN, NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNERGY SHOULDER COIL PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K991765(TRADITIONAL) ATTN: PETER ALTMAN PHONE NO : 203-926-7674 710 BRIDGEPORT AVENUE SE DECISION MADE: 02-AUG-99 P.O. BOX 860 510(k) SUMMARY AVAILABLE FROM FDA SHELTON, CT 06484-0197 DEVICE: MRGP OPTICAL TRACKING UNIT PICKER INTERNATIONAL, INC. 510(k) NO: K991943(TRADITIONAL) ATTN: ELAINE K KEELER PHONE NO : 440-473-5591 595 MINER ROAD SE DECISION MADE: 23-AUG-99 HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IPASS BOLUS TRACKING PICKER INTERNATIONAL, INC. 510(k) NO: K992412(SPECIAL) ATTN: ELAINE K KEELER PHONE NO : 440-473-5591 595 MINER RD. SE DECISION MADE: 17-AUG-99 HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLANMED SOPHIE AND SOPHIE CLASSIC PLANMED OY 510(k) NO: K991826(TRADITIONAL) ATTN: BOB PIENKOWSKI PHONE NO : 630-595-7077 362, BALM COURT SE DECISION MADE: 10-AUG-99 WOOD DALE, IL 60191 510(k) STATEMENT DEVICE: PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA) PLUS ORTHOPEDICS 510(k) NO: K990261(TRADITIONAL) ATTN: HARTMUT LOCH PHONE NO : 619-455-2400 3550 GENERAL ATOMICS CT. SE DECISION MADE: 27-AUG-99 SAN DIEGO, CA 92121-1194 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOHDL CHOLESTEROL REAGENT SET POINTE SCIENTIFIC, INC. 510(k) NO: K992002(TRADITIONAL) ATTN: WILLIAM F WALTERS PHONE NO : 313-383-7220 1025 JOHN A. PAPALAS DR. SE DECISION MADE: 05-AUG-99 LINCOLN PARK, MI 48146 510(k) STATEMENT DEVICE: BLULAZE PREMIER LASER SYSTEMS 510(k) NO: K992620(TRADITIONAL) ATTN: BETH A ROBERTS PHONE NO : 317-585-8160 3 MORGAN SE DECISION MADE: 20-AUG-99 IRVINE, CA 92718 510(k) STATEMENT DEVICE: ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/O PRINCETON BIOMEDITECH CORP. 510(k) NO: K992422(SPECIAL) ATTN: JEMO KANG PHONE NO : 800-726-2670 4242 U.S. RT. 1 SE DECISION MADE: 10-AUG-99 MONMOUTH JUNCTION, NJ 08852-1905 510(k) STATEMENT DEVICE: QUICKVUE ONE-STEP H. PYLORI II TEST QUIDEL CORP. 510(k) NO: K991747(TRADITIONAL) ATTN: ROBIN WEINER PHONE NO : 619-552-7908 10165 MCKELLAR CT. SE DECISION MADE: 04-AUG-99 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL RADIONICS, INC. 510(k) NO: K991237(TRADITIONAL) ATTN: NANCY MACDONALD PHONE NO : 718-272-1233 22 TERRY AVE. SE DECISION MADE: 30-AUG-99 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARSET, MODEL A10001E RD MEDICAL MFG., INC. 510(k) NO: K992104(ABBREVIATED) ATTN: CARLOS A RODRIGUEZ-GARCIA PHONE NO : 787-742-3800 CALLE ESCUDERO FINAL, BO. SE DECISION MADE: 23-AUG-99 FULLADOSA 510(k) SUMMARY AVAILABLE FROM FDA CUELBRA, PR DEVICE: REDI-TEST PCP REDWOOD BIOTECH INC. 510(k) NO: K991698(TRADITIONAL) ATTN: JANIS FREESTONE PHONE NO : 650-691-4770 2440 LEGHORN ST. SE DECISION MADE: 25-AUG-99 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRAINAGE BAG REMINGTON MEDICAL, INC. 510(k) NO: K990428(TRADITIONAL) ATTN: STEVE WOODY PHONE NO : 770-888-8520 6830 MEADOWRIDGE CT. SE DECISION MADE: 12-AUG-99 ALPHARETTA, GA 30005 510(k) STATEMENT DEVICE: ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING RESEARCH INSTRUMENTS LTD. 510(k) NO: K991261(TRADITIONAL) ATTN: DAVID C LANSDOWNE PHONE NO : 441 326 372753 KERNICK RD. SE DECISION MADE: 05-AUG-99 PENRYN, CORWALL, UNITED KINGDOM TR510(k) STATEMENT DEVICE: MONARCH II MINI MASK RESPIRONICS, INC. 510(k) NO: K992336(SPECIAL) ATTN: DAVID J VANELLA PHONE NO : 724-733-5866 1001 MURRY RIDGE DRIVE SE DECISION MADE: 13-AUG-99 MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217) RI MOS. S.R.L. 510(k) NO: K991895(TRADITIONAL) ATTN: JAMES DELANEY PHONE NO : 978-371-0066 100 MAIN ST. SE DECISION MADE: 12-AUG-99 SUITE 120 510(k) SUMMARY AVAILABLE FROM FDA CONCORD, MA DEVICE: RIWO DRIVE GENERATOR RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K984304(TRADITIONAL) ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113 353 CORPORATE WOODS PKWY. SE DECISION MADE: 12-AUG-99 VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPERATING LAPAROSCOPE, 10-5 MM, ANGELED, OPERATING LAPAROSCOPE 1 RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K991718(TRADITIONAL) ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113 353 CORPORATE WOODS PKWY SE DECISION MADE: 12-AUG-99 VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS ROCHE MOLECULAR SYSTEMS, INC. 510(k) NO: K973707(TRADITIONAL) ATTN: ALEX WESOLOWSKI PHONE NO : 908-253-7540 1080 U.S. HIGHWAY 202 SE DECISION MADE: 04-AUG-99 SOMERVILLE, NJ 08876-3711 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRAT ROCKWELL MEDICAL TECHNOLOGIES, INC510(k) NO: K983618(TRADITIONAL) ATTN: JEFFREY R SHIDEMAN PHONE NO : 612-835-4018 28025 OAKLAND OAKS CT. SE DECISION MADE: 05-AUG-99 WIXOM, MI 48393 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSVAGINAL ULTRASOUND PROBE HOLDER DEVICE RON-TECH MEDICAL LTD. 510(k) NO: K992071(TRADITIONAL) ATTN: AHAVA STEIN PHONE NO : 972 979 20673 P.O. BOX 454 SE DECISION MADE: 27-AUG-99 GINOT SHOMRON, ISRAEL 44853 510(k) STATEMENT DEVICE: FLEXIFLO ENTERAL FEEDING TUBE ROSS PRODUCTS, DIV. ABBOTT LABORAT510(k) NO: K992494(SPECIAL) ATTN: DANIEL HAMILTON PHONE NO : 614-624-3743 SE DECISION MADE: 25-AUG-99 510(k) STATEMENT DEVICE: ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-41 ROSSMAX INTL. LTD. 510(k) NO: K992387(SPECIAL) ATTN: MICHAEL YEH PHONE NO : 011 886 27835584 2F. NO. 10, ALLEY 20 LANE 106 SE DECISION MADE: 03-AUG-99 SECTION 3, NAN KANG ROAD 510(k) STATEMENT TAIPEI, CHINA (TAIWAN) DEVICE: ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-42 ROSSMAX INTL. LTD. 510(k) NO: K992388(SPECIAL) ATTN: MICHAEL YEH PHONE NO : 011 886 27835584 2F. NO. 10, ALLEY 20 LANE 106 SE DECISION MADE: 03-AUG-99 SEC 3 NON KANG RD. 510(k) STATEMENT TAIPEI, CHINA (TAIWAN) DEVICE: RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNC RUSCH INTL. 510(k) NO: K990619(TRADITIONAL) ATTN: KARENANN J BROZOWSKI PHONE NO : 603-532-7706 TALL PINES PARK SE DECISION MADE: 03-AUG-99 JAFFREY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAS ADENO TEST SA SCIENTIFIC, INC. 510(k) NO: K990630(TRADITIONAL) ATTN: J. WESSLING PHONE NO : 210-699-8800 4919 GOLDEN QUAIL SE DECISION MADE: 19-AUG-99 SAN ANTONIO, TX 78240 510(k) STATEMENT DEVICE: SAS ROTA TEST SA SCIENTIFIC, INC. 510(k) NO: K990842(TRADITIONAL) ATTN: J. WESSLING PHONE NO : 210-699-8800 4919 GOLDEN QUAIL SE DECISION MADE: 09-AUG-99 SAN ANTONIO, TX 78240 510(k) STATEMENT DEVICE: SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES SAFESKIN CORP. 510(k) NO: K992062(TRADITIONAL) ATTN: EUGENE V GOORCHENKO PHONE NO : 619-794-8111 12671 HIGH BLUFF DR. SE DECISION MADE: 25-AUG-99 SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE W SAFESKIN CORP. 510(k) NO: K992162(TRADITIONAL) ATTN: EUGENE V GOORCHENKO PHONE NO : 619-509-7010 12671 HIGH BLUFF DR. SE DECISION MADE: 30-AUG-99 SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SALTER LABS PEP DEVICE SALTER LABORATORIES 510(k) NO: K991788(TRADITIONAL) ATTN: DUANE KAZAL PHONE NO : 805-854-3166 100 WEST SYCAMORE RD. SE DECISION MADE: 06-AUG-99 ARVIN, CA 93203 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS SANGSTAT MEDICAL CORP. 510(k) NO: K991594(TRADITIONAL) ATTN: COLLEEN STEWART PHONE NO : 510-789-4540 6300 DUMBARTON CIRCLE SE DECISION MADE: 05-AUG-99 FREMONT, CA 94555 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXISCOPE IQ 101 SCHOELLY FIBEROPTIC, GMBH 510(k) NO: K992362(TRADITIONAL) ATTN: JOSEPH RESS PHONE NO : 617-965-7714 45 PONTIAC ROAD SE DECISION MADE: 05-AUG-99 NEWTON, MA 02248 510(k) STATEMENT DEVICE: SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES SECHRIST INDUSTRIES, INC. 510(k) NO: K992503(SPECIAL) ATTN: GREG GODFREY PHONE NO : 714-579-8318 4225 EAST LA PALMA SE DECISION MADE: 10-AUG-99 ANAHEIM, CA 92807 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEDATELEC ASP ACUPUNCTURE NEEDLES SEDATELEC 510(k) NO: K983798(TRADITIONAL) ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640 200 GREGORY LANE, SUITE C-100 SE DECISION MADE: 27-AUG-99 PLEASANT HILL, CA 94523-3389 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DN ACUPUNTURE NEEDLES SEDATELEC 510(k) NO: K983800(TRADITIONAL) ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640 200 GREGORY LANE, SUITE C-100 SE DECISION MADE: 27-AUG-99 PLEASANT HILL, CA 94523-3389 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITRILE EXAMINATION GLOVES POWDER FREE (WHITE) SELTOM PACIFIC SDN. BHD. 510(k) NO: K991776(TRADITIONAL) ATTN: S. SEGARAN PHONE NO : 603 735 6010 LOT 25, JALAN PJS 7/17 SE DECISION MADE: 11-AUG-99 SUNWAY INDUSTRIAL PARK 510(k) STATEMENT PETALING JAYA, SELANGOR, MALAYSIA 46150 DEVICE: LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING CLAIM SELTOM PACIFIC SDN. BHD. 510(k) NO: K991777(TRADITIONAL) ATTN: S. SEGARAN PHONE NO : 603 735 6010 LOT 25, JALAN PJS 7/17 SE DECISION MADE: 31-AUG-99 SUNWAY INDUSTRIAL PARK 510(k) STATEMENT PETALING JAYA, SELANGOR, MALAYSIA 46150 DEVICE: LATEX EXAMINATION GLOVES POLYMER COATED (POWDER-FREE) SELTOM PACIFIC SDN. BHD. 510(k) NO: K991778(TRADITIONAL) ATTN: S. SEGARAN PHONE NO : 603 735 6010 LOT 25, JALAN PJS 7/17 SE DECISION MADE: 31-AUG-99 SUNWAY INDUSTRIAL PARK 510(k) STATEMENT PETALING JAYA, SELANGOR, MALAYSIA 46150 DEVICE: NITRILE EXAMINATION GLOVES POWDER FREE (BLUE) SELTOM PACIFIC SDN. BHD. 510(k) NO: K991779(TRADITIONAL) ATTN: S. SEGARAN PHONE NO : 603 735 6010 LOT 25, JALAN PJS 7/17 SE DECISION MADE: 11-AUG-99 SUNWAY INDUSTRIAL PARK 510(k) STATEMENT PETALING JAYA, SELANGOR, MALAYSIA 46150 DEVICE: INFANT FLOW SYSTEM SENSORMEDICS CORP. 510(k) NO: K991972(SPECIAL) ATTN: ALEX STENZLER PHONE NO : 800-520-4368 22705 SAVI RANCH PKWY. SE DECISION MADE: 13-AUG-99 YORBA LINDA, CA 92887-4645 510(k) STATEMENT DEVICE: URINE DRUG SCREENING CONTROL SERACARE TECHNOLOGY 510(k) NO: K992395(TRADITIONAL) ATTN: RUSTY SEWELL PHONE NO : 512-445-5100 2170 WOODWARD ST. SE DECISION MADE: 26-AUG-99 AUSTIN, TX 78744-1832 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE SHANGHAI ANTARES INDUSTRIES, INC. 510(k) NO: K992017(TRADITIONAL) ATTN: JOHN LAI PHONE NO : 011 862 157814213 259 YUSHU RD., SE DECISION MADE: 05-AUG-99 CANGQIAO TOWNSHIP 510(k) STATEMENT SONGJIANG SHANGHAI, CHINA DEVICE: TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA GRE SHEN WEI (USA), INC. 510(k) NO: K992200(TRADITIONAL) ATTN: BELLE L CHOU PHONE NO : 510-429-8692 2845 WHIPPLE RD. SE DECISION MADE: 17-AUG-99 UNION CITY, CA 94587 510(k) STATEMENT DEVICE: SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG DILLY PLASTICS PRODUC510(k) NO: K992463(TRADITIONAL) ATTN: XINGLAI ZHOU PHONE NO : 011 863 113830158 NO. 16 ZHI NONG RD. SE DECISION MADE: 30-AUG-99 SHIJIAZHUANG, CHINA 050051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEM SIEMENS CORP. 510(k) NO: K991652(TRADITIONAL) ATTN: KATHLEEN RUTHERFORD PHONE NO : 732-321-4625 186 WOOD AVE., SOUTH SE DECISION MADE: 03-AUG-99 ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOMATOM PROJECT 10-CT SCANNERS SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K991764(TRADITIONAL) ATTN: ALICIA JUERGENSEN PHONE NO : 908-321-3243 186 WOOD AVENUE SOUTH SE DECISION MADE: 17-AUG-99 ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONOLINE 7XX DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K992046(TRADITIONAL) ATTN: STEVE HESLER PHONE NO : 425-557-1629 22010 S.E. 51ST STREET SE DECISION MADE: 13-AUG-99 ISSAQUAH, WA 98027-7002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GONOSTAT GONOCOCCAL DETECTION KIT SIERRA DIAGNOSTICS 510(k) NO: K991268(TRADITIONAL) ATTN: DONALD R STONE PHONE NO : 202-496-7620 1900 K STREET, N.W. SE DECISION MADE: 11-AUG-99 WASHINGTON, DC 20006-1108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K992644(SPECIAL) ATTN: SHEILA HEMEON-HEYER PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 23-AUG-99 NORTH ATTLEBORO, MA 02760-4153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLUOROPLASTIC VENTILATION TUBES SMITH & NEPHEW ENT. 510(k) NO: K992222(TRADITIONAL) ATTN: ALICIA E FARAGE PHONE NO : 901-373-0200 2925 APPLING RD. SE DECISION MADE: 26-AUG-99 BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE SMITH & NEPHEW, INC. 510(k) NO: K990666(ABBREVIATED) ATTN: JANET JOHNSON GREEN PHONE NO : 901-396-2121 1450 BROOKS RD. SE DECISION MADE: 06-AUG-99 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TAC-2, TRANSMISSION ATTENUATION CORRECTION AND DST, DST-XL GAMMA SMV AMERICA 510(k) NO: K991565(TRADITIONAL) ATTN: PHIL VERNON PHONE NO : 330-425-1340 8380 DARROW RD. SE DECISION MADE: 02-AUG-99 TWINSBURG, OH 44087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNA-LOK PLUS SPINAL SYSTEM SOFAMOR DANEK USA,INC. 510(k) NO: K991198(TRADITIONAL) ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 27-AUG-99 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS SOFTCHROME, INC. 510(k) NO: K991995(TRADITIONAL) ATTN: MARTIN DALSING PHONE NO : 623 GLACIER DRIVE SE DECISION MADE: 27-AUG-99 GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOUND VASER SYSTEM SOUND SURGICAL TECHNOLOGIES LLC 510(k) NO: K991791(TRADITIONAL) ATTN: WILLIAM W CIMINO PHONE NO : 303-926-8608 1300 PLAZA COURT NORTH # 203 SE DECISION MADE: 12-AUG-99 LAFAYETTE, CO 80026 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINIJECT SPARTAN ULTRASONICS INC. 510(k) NO: K991888(TRADITIONAL) ATTN: ALDO EAGLE PHONE NO : 636-343-8300 1663 FENTON BUSINESS PARK CT. SE DECISION MADE: 25-AUG-99 FENTON, MO 63026 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SERFAS, SERFAS GENERATOR, SERFAS CONSOLE, SERFAS PROBE, SERFAS H STRYKER ENDOSCOPY 510(k) NO: K991960(TRADITIONAL) ATTN: N. MANI PRAKASH PHONE NO : 408-567-9100 2590 WALSH AVE. SE DECISION MADE: 13-AUG-99 SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QS DELIVERY SYSTEM SUB-Q, INC. 510(k) NO: K991254(TRADITIONAL) ATTN: DAN W MILLER PHONE NO : 949-369-5751 1062-D CALLE NEGOCIO SE DECISION MADE: 23-AUG-99 SAN CLEMENTE, CA 92673 510(k) STATEMENT DEVICE: INTER-OP METASUL ACETABULAR SYSTEM SULZER ORTHOPEDICS, INC. 510(k) NO: K974728(TRADITIONAL) ATTN: MITCHELL A DHORITY PHONE NO : 512-432-9202 9900 SPECTRUM DR. SE DECISION MADE: 03-AUG-99 AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL SURETEX PROPHYLACTICS (INDIA) LTD.510(k) NO: K992081(ABBREVIATED) ATTN: LON D MCILVAIN PHONE NO : 334-794-4232 1500 INDUSTRIAL ROAD SE DECISION MADE: 19-AUG-99 P.O. BOX 1252 510(k) SUMMARY AVAILABLE FROM FDA DOTHAN, AL 36302 DEVICE: SNN SYSTEM WITH OLIVIER DOUBLE CHUCK SUPPORT ARM OPTION SURGICAL NAVIGATION SPECIALISTS IN510(k) NO: K992457(TRADITIONAL) ATTN: CAROL NAKAGAWA PHONE NO : 905 672 2100 6509 AIRPORT RD. SE DECISION MADE: 27-AUG-99 MISSISSAUGA, ONTARIO, CANADA L4V 1510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND SWEMED LAB INTERNATIONAL AB 510(k) NO: K991273(TRADITIONAL) ATTN: EDWARD C WILSON JR. PHONE NO : 202-637-5839 555 13TH STREET N.W. SE DECISION MADE: 18-AUG-99 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRODIGY 4 TRANSLUCENT SHADES SYBRON DENTAL SPECIALTIES INC. 510(k) NO: K992118(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVENUE SE DECISION MADE: 18-AUG-99 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXUS 2 SYBRON DENTAL SPECIALTIES INC. 510(k) NO: K992160(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVENUE SE DECISION MADE: 18-AUG-99 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES CERVIFIX SYSTEM SYNTHES SPINE 510(k) NO: K991089(TRADITIONAL) ATTN: JONATHAN GILBERT PHONE NO : 610-647-9700 P.O. BOX 0548 SE DECISION MADE: 27-AUG-99 1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301 DEVICE: H20- TETHERED OPTION TELEFACTOR CORP. 510(k) NO: K992291(SPECIAL) ATTN: JAMES S BRYAN PHONE NO : 610-825-4555 1094 NEW DEHAVEN AVE. SE DECISION MADE: 06-AUG-99 WEST CONSHOHOCKEN, PA 19428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIFOCUS OPTITORQUE TERUMO MEDICAL CORP. 510(k) NO: K992051(SPECIAL) ATTN: YUK-TING LEWIS PHONE NO : 410-392-7213 125 BLUE BALL RD. SE DECISION MADE: 10-AUG-99 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRAVASCULAR ADMINISTRATION SET THE KIPP GROUP 510(k) NO: K991932(TRADITIONAL) ATTN: GARY WERSCHMIDT PHONE NO : 909-390-9080 930 WANAMAKER AVE. SE DECISION MADE: 20-AUG-99 ONTARIO, CA 91761 510(k) STATEMENT DEVICE: CTD MARK I TRACTION DEVICE THERASYS, INC. 510(k) NO: K991931(TRADITIONAL) ATTN: EARNIE S PHILPOT PHONE NO : 937-643-3411 2295 NORTH MORAIN DR. SE DECISION MADE: 12-AUG-99 MORAINE, OH 45439 510(k) STATEMENT DEVICE: ACCUTOUCH POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION G TILLOTSON HEALTHCARE CORP. 510(k) NO: K992428(TRADITIONAL) ATTN: THOMAS N TILLOTSON PHONE NO : 603-472-6600 360 ROUTE 101 SE DECISION MADE: 09-AUG-99 BEDFORD, NH 03110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AEQUALIS SHOULDER PROSTHESIS TORNIER S.A. 510(k) NO: K980244(TRADITIONAL) ATTN: DAVID W SCHLERF PHONE NO : 510-356-2640 1000 BURNETT AVENUE SE DECISION MADE: 23-AUG-99 SUITE 450 510(k) SUMMARY AVAILABLE FROM FDA CONCORD, CA 94520 DEVICE: ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K991766(TRADITIONAL) ATTN: PAUL BIGGINS PHONE NO : 714-730-5000 2441 MICHELLE DR. SE DECISION MADE: 10-AUG-99 P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA TUSTIN, CA 92681-2068 DEVICE: OPART, MODEL MRT-600 TOSHIBA AMERICA MRI, INC. 510(k) NO: K991740(TRADITIONAL) ATTN: HSU CHANG PHONE NO : 650-872-2722 280 UTAH AVE. SE DECISION MADE: 02-AUG-99 SOUTH SAN FRANCISCO, CA 94080-6883510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIA-PACK FOLATE ASSAY TOSOH MEDICS, INC. 510(k) NO: K992365(TRADITIONAL) ATTN: JUDITH E LOEBEL PHONE NO : 650-615-4970 347 OYSTER POINT BLVD., SE DECISION MADE: 10-AUG-99 SUITE 201 510(k) STATEMENT SOUTH SAN FRANCISCO, CA 94080 DEVICE: TOUCH TEAR IGE MICROASSAY KIT TOUCH SCIENTIFIC, INC. 510(k) NO: K991316(TRADITIONAL) ATTN: ALAN J TOUCH PHONE NO : 919-872-4445 3209 GRESHAM LAKE RD. SE DECISION MADE: 09-AUG-99 SUITE 112 510(k) STATEMENT RALEIGH, NC 27615 DEVICE: MXU-125 OR TMX-125 TREX MEDICAL CORP. 510(k) NO: K992229(TRADITIONAL) ATTN: KELVIN BURROUGHS PHONE NO : 203-731-8442 36 APPLE RIDGE RD. SE DECISION MADE: 06-AUG-99 DANBURY, CT 06810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TWO RIVERS POWER LIFT/RECLINE CHAIR TWO RIVERS, LLC 510(k) NO: K991693(TRADITIONAL) ATTN: CHRIS WHITAKER PHONE NO : 423-626-4990 P.O. BOX 356 SE DECISION MADE: 17-AUG-99 204 SOTH BROAD STREET 510(k) STATEMENT NEW TAZEWELL, TN 37825 DEVICE: UM-L20/ UM-L30 UNION MEDICAL ENGENEERING CO., LTD510(k) NO: K982860(TRADITIONAL) ATTN: ANNIE VALEZ PHONE NO : 305-663-9936 8930 S.W. 68TH COURT #H3 SE DECISION MADE: 13-AUG-99 MIAMI, FL 33156 510(k) STATEMENT DEVICE: SKIN 2 FORTE SILICONE SHEETING UNITED HOSPITAL TECHNOLOGIES, INC.510(k) NO: K990651(TRADITIONAL) ATTN: SAMUEL SWETLAND PHONE NO : 954-433-7480 10320 USA TODAY WAY SE DECISION MADE: 13-AUG-99 MIRAMAR, FL 33025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UROSURGE SPIRALFLO URETERAL STENT UROSURGE, INC. 510(k) NO: K992391(TRADITIONAL) ATTN: STEVEN J PREISS PHONE NO : 319-626-5335 2660 CROSSPARK RD. SE DECISION MADE: 18-AUG-99 CORALVILLE, IA 52241 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONOPOLAR ELECTRODES AND CABLES US ENDO, INC. 510(k) NO: K992485(TRADITIONAL) ATTN: JONEL MANCIU PHONE NO : 826 EAGLE DRIVE SE DECISION MADE: 27-AUG-99 BENSENVILLE, IL 60106 510(k) STATEMENT DEVICE: CADPLAN HELIOS OPTION 6.0 VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K984532(TRADITIONAL) ATTN: LINDA S NASH PHONE NO : 650-424-6990 3045 HANOVER STREET SE DECISION MADE: 09-AUG-99 PALO ALTO, CA 94304-1120 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENTANA ER PRIMARY ANTIBODY (CLONE 6F11) VENTANA, INC. 510(k) NO: K984567(TRADITIONAL) ATTN: JUDITH FREDERICK PHONE NO : 520-690-2731 3865 NORTH BUSINESS CENTER SE DECISION MADE: 12-AUG-99 DRIVE 510(k) SUMMARY AVAILABLE FROM FDA TUCSON, AZ 85705 DEVICE: VINYL POWDERED EXAM GLOVE / CAT.# 15-020 VITALCARE GROUP, INC. 510(k) NO: K992289(TRADITIONAL) ATTN: GINGER TALLEY PHONE NO : 305-620-4007 15800 N.W. 13TH AVE. SE DECISION MADE: 04-AUG-99 MIAMI, FL 33169 510(k) STATEMENT DEVICE: PMS 750 FINGERSWITCH WALLACH SURGICAL DEVICES, INC. 510(k) NO: K991669(TRADITIONAL) ATTN: MICHAEL MALIS PHONE NO : 203-700-2000 235 EDISON RD. SE DECISION MADE: 12-AUG-99 ORANGE, CT 06477 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VHS SUPRACONDYLAR PLATE SYSTEM WALTER ABENDSCHEIN, M.D. 510(k) NO: K991806(TRADITIONAL) ATTN: WALTER ABENDSCHEIN PHONE NO : 301-656-4317 5530 WISCONSIN AVENUE SE DECISION MADE: 06-AUG-99 SUITE 705 510(k) SUMMARY AVAILABLE FROM FDA CHEVY CHASE, MD 20815 DEVICE: WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00 WELLS JOHNSON CO. 510(k) NO: K991437(TRADITIONAL) ATTN: KEN RODENBURG PHONE NO : 520-298-6069 8000 SOUTH KOLB RD. SE DECISION MADE: 30-AUG-99 TUCSON, AZ 85706 510(k) STATEMENT DEVICE: WHITESIDE BIOMECHANICS SPINAL SYSTEM WHITESIDE BIOMECHANICS, INC. 510(k) NO: K991678(TRADITIONAL) ATTN: DEBRA MEYER PHONE NO : 314-996-8540 12634 OLIVE BLVD. SE DECISION MADE: 12-AUG-99 ST. LOUIS, MO 63141 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMU ZEUS SCIENTIFIC, INC. 510(k) NO: K991820(TRADITIONAL) ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744 200 EVANS WAY SE DECISION MADE: 12-AUG-99 BRANCHBURG, NJ 08876 510(k) STATEMENT TOTAL 510(k)s THIS PERIOD 326 TOTAL WITH SUMMARIES 211 TOTAL WITH STATEMENTS 115
Updated 10/5/1999
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