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510(k)s Final Decisions Rendered for April 1999 |
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DEVICE: ALBUMIN BCG, MODEL AL 103-01 A.P. TOTAL CARE, INC. 510(k) NO: K990978(TRADITIONAL) ATTN: LUIS P LEON PHONE NO : 203-335-9277 70 HAWLEY AVE, SE DECISION MADE: 28-APR-99 PO BOX 6216 510(k) STATEMENT BRIDGEPORT, CT DEVICE: AAP CANNULATED SCREW, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM AAP IMPLANTATE AG 510(k) NO: K990776(TRADITIONAL) ATTN: ELLEN HENKE-KNUPP PHONE NO : 508-747-6098 73 EAGLES NEST ROAD SE DECISION MADE: 29-APR-99 DUXBURY, MA 02332 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ETEST FOR CEFUROXIME AB BIODISK 510(k) NO: K990722(TRADITIONAL) ATTN: ANNE BOLMSTROM PHONE NO : 468 730 0760 DALVAGEN 10 SE DECISION MADE: 22-APR-99 SOLNA, SWEDEN 16956 510(k) STATEMENT DEVICE: MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15 ADVANCED SPINE FIXATION SYSTEMS, I510(k) NO: K990845(SPECIAL) ATTN: GREG HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 13-APR-99 IRVINE, CA 92606 510(k) STATEMENT DEVICE: ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT AB AESCULAP, INC. 510(k) NO: K991223(TRADITIONAL) ATTN: STEVE REITZLER PHONE NO : 619-977-1465 13221 MARICOTTE PLACE SE DECISION MADE: 30-APR-99 SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONVERTORS SURGICAL GOWNS ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K991034(SPECIAL) ATTN: SHARON ROBBINS PHONE NO : 847-785-3311 1500 WAUKEGAN RD. SE DECISION MADE: 16-APR-99 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE ALLIANCE RUBBER PRODUCTS SDN. BHD.510(k) NO: K990427(TRADITIONAL) ATTN: CHUA HOOI KOON PHONE NO : 600 459 3223559376 LOT 2716&2720, MK 7, KAWASAN SE DECISION MADE: 23-APR-99 PERINDUSTRIAN BUKIT PANCHOR 510(k) STATEMENT NINONG TEBAL, PULAU PINANG, MALAYSIA 14300 DEVICE: NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, GREEN COLOR ALLIANCE RUBBER PRODUCTS SDN. BHD.510(k) NO: K990485(TRADITIONAL) ATTN: CHUA HOOI KOON PHONE NO : 600 458 32235 PERINDUSTRIAN BUKIT PANCHOR SE DECISION MADE: 23-APR-99 14300 NIBONG TEBAL 510(k) STATEMENT PULAU PINANG, MALAYSIA 52446-U DEVICE: NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, BLUE COLOR. ALLIANCE RUBBER PRODUCTS SDN. BHD.510(k) NO: K990486(TRADITIONAL) ATTN: CHUA HOOI KOON PHONE NO : 600 459 32235 PERINDUSTRIAN BUKIT PANCHOR SE DECISION MADE: 23-APR-99 14300 NIBONG TEBAL 510(k) STATEMENT PULAU PINANG, MALAYSIA 52446-U DEVICE: ALTHIN MEDICAL AB ALTRACART II ALTHIN MEDICAL AB 510(k) NO: K990010(TRADITIONAL) ATTN: ULF LUNDGREN PHONE NO : 46 457 75900 BOX 39, (FRIDHEMSV. 15) SE DECISION MADE: 15-APR-99 372 21 RONNEBY, SWEDEN 372 21 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD AMBU, INC. 510(k) NO: K982722(TRADITIONAL) ATTN: SANJAY PARIKH PHONE NO : 410-636-1144 611 NORTH HAMMONDS FERRY RD. SE DECISION MADE: 12-APR-99 LINTHICUM, MD 21090-1356 510(k) STATEMENT DEVICE: SHARPS COLLECTION CONTAINER - SAF-T-SHELL AMERICAN MEDICAL MFG., INC. 510(k) NO: K982029(TRADITIONAL) ATTN: MIKE HOFTMAN PHONE NO : 818-701-7171 9410 DESOTO AVE., UNIT J SE DECISION MADE: 06-APR-99 CHATSWORTH, CA 91311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVIA PAIN MEDICATION DELIVERY SYSTEM AMTEC MEDICAL, INC. 510(k) NO: K990312(TRADITIONAL) ATTN: TERRELL L FRIEDRICH PHONE NO : 800-221-5293 9119 METRIC BLVD. SE DECISION MADE: 22-APR-99 AUSTIN, TX 78758 510(k) STATEMENT DEVICE: URETERAL ACCESS SHEATH SET APPLIED MEDICAL RESOURCES 510(k) NO: K990775(TRADITIONAL) ATTN: ANIL BHALANI PHONE NO : 949-582-6120 26051 MERIT CIRCLE, #104 SE DECISION MADE: 21-APR-99 LAGUNA HILLS, CA 92653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEADED BIO-ABSORBABLE CORKSCREW MODEL #AR-1921BU ARTHREX, INC. 510(k) NO: K990361(TRADITIONAL) ATTN: VERNON C BROWN PHONE NO : 941-643-5553 2885 SOUTH HORSESHOE DR. SE DECISION MADE: 14-APR-99 NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM AVANTA ORTHOPAEDICS, INC. 510(k) NO: K990596(TRADITIONAL) ATTN: LOUISE M FOCHT PHONE NO : 619-452-8580 9369 CARROLL PARK RD., SUITE A SE DECISION MADE: 29-APR-99 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RENU MULTIPLUS MULTI-PURPOSE SOLUTION BAUSCH & LOMB, INC. 510(k) NO: K990422(TRADITIONAL) ATTN: PAUL G STAPLETON PHONE NO : 716-338-8172 1400 NORTH GOODMAN ST. SE DECISION MADE: 27-APR-99 ROCHESTER, NY 14692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER BECTON DICKINSON & CO. 510(k) NO: K984059(TRADITIONAL) ATTN: CHARLES J WELLE PHONE NO : 801-565-2535 9450 SOUTH STATE STREET SE DECISION MADE: 09-APR-99 SANDY, UT 84070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01 BIO-RAD LABORATORIES, INC. 510(k) NO: K990587(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO RD. SE DECISION MADE: 07-APR-99 IRVINE, CA 92618-2017 510(k) STATEMENT DEVICE: ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10 BIO-RAD LABORATORIES, INC. 510(k) NO: K990610(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO ROAD SE DECISION MADE: 27-APR-99 IRVINE, CA 92618 510(k) STATEMENT DEVICE: MICROPLATE NEONATAL GALT ASSAY BIO-RAD LABORATORIES, INC. 510(k) NO: K990827(SPECIAL) ATTN: JULIET CARRARA PHONE NO : 510-741-6188 4000 ALFRED NOBEL DR. SE DECISION MADE: 09-APR-99 HERCULES, CA 94547 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789 BIO-RAD LABORATORIES, INC. 510(k) NO: K990858(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO RD. SE DECISION MADE: 21-APR-99 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO LIQUICHEK SPINAL FLUID CONTROL, ITEM NOS. 751, 7 BIO-RAD LABORATORIES, INC. 510(k) NO: K990888(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO ROAD SE DECISION MADE: 07-APR-99 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405 BIO-RAD LABORATORIES, INC. 510(k) NO: K990928(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO ROAD SE DECISION MADE: 16-APR-99 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: O-RING ABUTMENT BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K990277(TRADITIONAL) ATTN: DIANA M EASTON PHONE NO : 205-967-7880 ONE PERINETER PARK SOUTH SE DECISION MADE: 09-APR-99 SUITE 230, SOUTH 510(k) SUMMARY AVAILABLE FROM FDA BIRMINGHAM, AL 35243 DEVICE: SINGLE AXLE TOTAL ELBOW BIOMET, INC. 510(k) NO: K983036(TRADITIONAL) ATTN: FRED MCCLURE PHONE NO : 219-372-1568 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 30-APR-99 WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROVIDENCE CUP SYSTEM BIOPRO, INC. 510(k) NO: K990821(TRADITIONAL) ATTN: CHERYL WARSINSKE PHONE NO : 810-982-7777 17 17TH STREET SE DECISION MADE: 29-APR-99 PORT HURON, MI 48060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AU6 BIOSOUND ESAOTE, INC. 510(k) NO: K990360(TRADITIONAL) ATTN: COLLEEN HIITLE PHONE NO : 317-849-1793 8000 CASTLEWAY DR. SE DECISION MADE: 30-APR-99 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLEASE 6200 ANAESTHESIA VENTILATOR BLEASE MEDICAL EQUIPMENT LTD. 510(k) NO: K982132(TRADITIONAL) ATTN: FRANCIS X CASEY PHONE NO : 12601 RESEARCH PARKWAY SE DECISION MADE: 15-APR-99 ATT: FRANCIS X CASEY 510(k) STATEMENT ORLANDO, FL 32826 DEVICE: BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE BLEASE MEDICAL EQUIPMENT LTD. 510(k) NO: K982137(TRADITIONAL) ATTN: FRANCIS X CASEY PHONE NO : 12601 RESEARCH PARKWAY SE DECISION MADE: 09-APR-99 ATT: FRANCIS X CASEY 510(k) STATEMENT ORLANDO, FL 32826 DEVICE: COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYS BOEHRINGER MANNHEIM CORP. DBA ROCH510(k) NO: K983892(TRADITIONAL) ATTN: LUANN OCHS PHONE NO : 317-845-2000 9115 HAGUE ROAD SE DECISION MADE: 13-APR-99 INDIANAPOLIS, IN 46256 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE) BRIGHTWAY HOLDINGS SDN. BHD. 510(k) NO: K990539(TRADITIONAL) ATTN: G. BASKARAN PHONE NO : 603 343 1007 LOT 1559, JALAN ISTIMEWA SE DECISION MADE: 09-APR-99 BATU BELAH, KLANG 510(k) STATEMENT SELANGOR DARUL EHSAN, MALAYSIA 42100 DEVICE: BRIGHTWAY BRAND LATEX EXAMINATION GLOVE (LOW PROTEIN) BRIGHTWAY HOLDINGS SDN. BHD. 510(k) NO: K990540(TRADITIONAL) ATTN: G. BASKARAN PHONE NO : 603 343 1007 LOT 1559, JALAN ISTIMEWA SE DECISION MADE: 09-APR-99 BATU BELAH, KLANG 510(k) STATEMENT SELANGOR DARUL EHSAN, MALAYSIA 42100 DEVICE: BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE) BRIGHTWAY HOLDINGS SDN. BHD. 510(k) NO: K990541(TRADITIONAL) ATTN: G. BASKARAN PHONE NO : 603 343 1007 LOT 1559, JALAN ISTIMEWA SE DECISION MADE: 09-APR-99 BATU BELAH, KLANG 510(k) STATEMENT SELANGOR DARUL EHSAN, MALAYSIA 42100 DEVICE: BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED) BRIGHTWAY HOLDINGS SDN. BHD. 510(k) NO: K990542(TRADITIONAL) ATTN: G. BASKARAN PHONE NO : 603 343 1007 LOT 1559, JALAN ISTIMEWA SE DECISION MADE: 09-APR-99 BATU BELAH, KLANG 510(k) STATEMENT SELANGOR DARUL EHSAN, MALAYSIA 42100 DEVICE: BRIGHTWAY BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER F BRIGHTWAY HOLDINGS SDN. BHD. 510(k) NO: K990543(TRADITIONAL) ATTN: G. BASKARAN PHONE NO : 603 343 1007 LOT 1559, JALAN ISTIMEWA SE DECISION MADE: 09-APR-99 BATU BELAH, KLANG 510(k) STATEMENT SELANGOR DARUL EHSAN, MALAYSIA 42100 DEVICE: GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE BROADLINE MEDICAL INDUSTRIES 510(k) NO: K990584(TRADITIONAL) ATTN: ANNA M RAMZA PHONE NO : 1432 SHIRE CIRCLE SE DECISION MADE: 23-APR-99 INVERNESS, IL 60067 510(k) STATEMENT DEVICE: INTERPLANT BURDETTE MEDICAL SYSTEMS, INC. 510(k) NO: K982696(TRADITIONAL) ATTN: EVERETTE C BURDETTE PHONE NO : 217-239-0900 206 N. RANDOLPH STREET SE DECISION MADE: 01-APR-99 SUITE 301 510(k) SUMMARY AVAILABLE FROM FDA CHAMPAIGN, IL 61820 DEVICE: ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, BUSINESS SUPPORT INTL. 510(k) NO: K982365(TRADITIONAL) ATTN: DAGMAR S MASER PHONE NO : 312 042 89591 AMSTEL 320-I SE DECISION MADE: 08-APR-99 AMSTERDAM, NETHERLANDS 1017-AP 510(k) STATEMENT DEVICE: HELIOFORM GOLD-BASED ALLOY C. HAFNER GMBH & CO. 510(k) NO: K990670(TRADITIONAL) ATTN: JOHN F LEMKER PHONE NO : 312-372-1121 THREE FIRST NATIONAL PLAZA SE DECISION MADE: 02-APR-99 70 WEST MADISON ST. SUITE 3300 510(k) SUMMARY AVAILABLE FROM FDA CHICAGO, IL 60602-4207 DEVICE: CARDIAC DIAGNOSTIC SYSTEM MODEL CH 2000 CAMBRIDGE HEART, INC. 510(k) NO: K983102(TRADITIONAL) ATTN: JOHN D GREENBAUM PHONE NO : 954-680-2548 20310 SW 48TH ST. SE DECISION MADE: 12-APR-99 FT. LAUDERDALE, FL 33332 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANTOR & SILVER 5X TINTED (HIOXIFILCON A) SOFT (SPHERICAL & TORI CANTOR & SILVER LTD. 510(k) NO: K990757(TRADITIONAL) ATTN: MARTIN DALSING PHONE NO : 970-243-5490 623 GLACIER DRIVE SE DECISION MADE: 21-APR-99 GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEARLY ME RETOUCH SILICONE SCAR REDUCTION SHEETS CAPITAL MARKETING TECHNOLOGIES, IN510(k) NO: K984213(TRADITIONAL) ATTN: JOHN SNYDER PHONE NO : 800-887-3370 3630 SOUTH I 35, SUITE A SE DECISION MADE: 14-APR-99 WACO, TX 76706 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARESIDE CKMB CARESIDE, INC. 510(k) NO: K990434(TRADITIONAL) ATTN: KENNETH B ASARCH PHONE NO : 310-338-6767 6100 BRISTOL PARKWAY SE DECISION MADE: 19-APR-99 CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARESIDE CK CARESIDE, INC. 510(k) NO: K990439(TRADITIONAL) ATTN: KENNETH B ASARCH PHONE NO : 310-338-6767 6100 BRISTOL PARKWAY SE DECISION MADE: 19-APR-99 CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLOOD PRESSURE METER, MODELS CH-491, CH-481, CH-471 CITIZEN WATCH CO., LTD. 510(k) NO: K984223(SPECIAL) ATTN: JOSEPH D EDMONDSON JR PHONE NO : 202-672-5354 3000 K STREET, N.W., SUITE 500 SE DECISION MADE: 28-APR-99 WASHINGTON, DC 20007 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EEG ELECTRODES MODEL "445 SERIES" CLASS A ENT. 510(k) NO: K982053(TRADITIONAL) ATTN: JANICE A AUDI PHONE NO : 760-365-9121 7607 LUCERNE VISTA SE DECISION MADE: 20-APR-99 YUCCA VALLEY, CA 92284 510(k) STATEMENT DEVICE: CODAN CHEMOSPIKE CODAN US CORP. 510(k) NO: K990711(TRADITIONAL) ATTN: FERGIE FERGUSON PHONE NO : 800-332-6326 3511 WEST SUNFLOWER AVE. SE DECISION MADE: 13-APR-99 SANTA ANA, CA 92704-6944 510(k) STATEMENT DEVICE: AUTOSTAT II ANTI-SM/RNP ELISA COGENT DIAGNOTICS LTD. 510(k) NO: K990624(TRADITIONAL) ATTN: DANIELLE M KNIGHT PHONE NO : 441 314 457111 PENTLANDS SCIENCE PARK SE DECISION MADE: 28-APR-99 BUSH LOAN 510(k) STATEMENT EDINBURGH, UNITED KINGDOM EH26 OPL DEVICE: AUTOSTAT II ANTI-SM ELISA COGENT DIAGNOTICS LTD. 510(k) NO: K990625(TRADITIONAL) ATTN: DANIELLE M KNIGHT PHONE NO : 441 314 457111 PENTLANDS SCIENCE PARK SE DECISION MADE: 28-APR-99 BUSH LOAN 510(k) STATEMENT EDINBURGH, UNITED KINGDOM EH26 OPL DEVICE: AUTOSTAT II ANTI-SS-B/LA ELISA COGENT DIAGNOTICS LTD. 510(k) NO: K990626(TRADITIONAL) ATTN: DANIELLE M KNIGHT PHONE NO : 441 314 457111 PENTLANDS SCIENCE PARK SE DECISION MADE: 28-APR-99 BUSH LOAN 510(k) STATEMENT EDINBURGH, UNITED KINGDOM EH26 OPL DEVICE: AUTOSTAT II ANTI-SS-A/RO ELISA COGENT DIAGNOTICS LTD. 510(k) NO: K990627(TRADITIONAL) ATTN: DANIELLE M KNIGHT PHONE NO : 441 314 457111 PENTLANDS SCIENCE PARK SE DECISION MADE: 28-APR-99 BUSH LOAN 510(k) STATEMENT EDINBURGH, UNITED KINGDOM EH26 OPL DEVICE: AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)EL COGENT DIAGNOTICS LTD. 510(k) NO: K990796(TRADITIONAL) ATTN: DANIELLE M KNIGHT PHONE NO : 714-933-3000 PENTLANDS SCIENCE PARK SE DECISION MADE: 28-APR-99 BUSH LOAN 510(k) STATEMENT EDINBURGH, UNITED KINGDOM EH26 OPL DEVICE: AUTOSTAT II ANTI-SCL-70 ELISA COGENT DIAGNOTICS LTD. 510(k) NO: K990797(TRADITIONAL) ATTN: DANIELLE M KNIGHT PHONE NO : 44 131 4457111 PENTLANDS SCIENCE PARK SE DECISION MADE: 28-APR-99 BUSH LOAN 510(k) STATEMENT EDINBURGH, UNITED KINGDOM EH26 OPL DEVICE: MODIFIED VERSAPULSE SELECT SINGLE WAVELENGTH, HO: YAG AND DUAL W COHERENT, INC. 510(k) NO: K990947(TRADITIONAL) ATTN: MICHELLE DEETON PHONE NO : 408-764-3601 2400 CONDENSA ST. SE DECISION MADE: 27-APR-99 SANTA CLARA, CA 95051-0901 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOCUS PILOT CONTOURING WORKSTATION COMPUTERIZED MEDICAL SYSTEMS, INC.510(k) NO: K981535(TRADITIONAL) ATTN: MICHAEL A PARSONS PHONE NO : 314-993-0003 1195 CORPORATE LAKE DR. SE DECISION MADE: 02-APR-99 ST. LOUIS, MO 63132-1716 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OXYCON LENS CON-CISE CONTACT LENS CO. 510(k) NO: K990895(TRADITIONAL) ATTN: DANIEL J MANELLI PHONE NO : 202-261-1000 2000 M STREET NW, SUITE 700 SE DECISION MADE: 14-APR-99 WASHINGTON, DC 20036 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENVY GUIDING CATHETER COOK, INC. 510(k) NO: K990726(SPECIAL) ATTN: APRIL LAVENDER PHONE NO : 812-339-2235 925 SOUTH CURRY PIKE SE DECISION MADE: 02-APR-99 BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORDIA PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY CORDIS CORP. 510(k) NO: K990631(TRADITIONAL) ATTN: CHARLES J RYAN PHONE NO : 908-412-7446 40 TECHNOLOGY DRIVE SE DECISION MADE: 30-APR-99 WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-ST COULTER CORP. 510(k) NO: K990172(TRADITIONAL) ATTN: MARION S GAIDE PHONE NO : 305-380-4331 11800 SW 147 AVENUE SE DECISION MADE: 13-APR-99 MIAMI, FL 33169 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS COULTER CORP. 510(k) NO: K990327(TRADITIONAL) ATTN: MARION S GAIDE PHONE NO : 305-380-2594 11800 SW 147 AVENUE SE DECISION MADE: 26-APR-99 MIAMI, FL 33169 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COULTER AC T DIFF 2 ANALYZER COULTER CORP. 510(k) NO: K990352(TRADITIONAL) ATTN: THOMAS J ENGLISH PHONE NO : 305-380-4331 11800 SW 147 AVENUE SE DECISION MADE: 01-APR-99 MIAMI, FL 33169 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVISED C-REACTIVE PROTEIN CALIBRATOR DADE BEHRING, INC. 510(k) NO: K990824(TRADITIONAL) ATTN: LORRAINE PIESTRAK PHONE NO : 302-631-6279 P.O. BOX 6101, SE DECISION MADE: 16-APR-99 MAIL STOP 514 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE DADE BEHRING, INC. 510(k) NO: K990825(TRADITIONAL) ATTN: LORRAINE PIESTRAK PHONE NO : 302-631-6279 P.O. BOX 6101 SE DECISION MADE: 16-APR-99 ROUTE 896, GLASGOW BLDG. 500 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS DADE MICROSCAN, INC. 510(k) NO: K983711(TRADITIONAL) ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105 2040 ENTERPRISE BLVD. SE DECISION MADE: 27-APR-99 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DAUM NEUROGATE TROCAR DAUM GMBH 510(k) NO: K990782(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 410-451-0639 P.O. BOX 4341 SE DECISION MADE: 28-APR-99 CROFTON, MD 21114 510(k) STATEMENT DEVICE: SILK SUTURE DAVIS & GECK, INC. 510(k) NO: K982853(TRADITIONAL) ATTN: VANADA JOHNSON PHONE NO : 314-895-4100 444 MCDONNELL BLVD. SE DECISION MADE: 30-APR-99 HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRINITY II SINGLE CHAMBER DVT PUMP DELPHI CONSULTING GROUP 510(k) NO: K983680(TRADITIONAL) ATTN: J. HARVEY KNAUSS PHONE NO : 713-723-8169 11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 28-APR-99 HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE BAGNOLI-8 EMG SYSTEM DELSYS INC. 510(k) NO: K990356(TRADITIONAL) ATTN: GIANLUCA DE LUCA PHONE NO : 617-326-0599 PO BOX 15734 SE DECISION MADE: 29-APR-99 BOSTON, MA 02215 510(k) STATEMENT DEVICE: SOFT TISSUE SUTURE WASHER DEPUY, INC. 510(k) NO: K991135(TRADITIONAL) ATTN: JANET G JOHNSON PHONE NO : 219-372-7484 700 ORTHOPAEDIC DRIVE SE DECISION MADE: 29-APR-99 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERAPEP DHD HEALTHCARE 510(k) NO: K983467(TRADITIONAL) ATTN: JEAN WALLACE PHONE NO : 315-697-2221 125 RASBACH ST. SE DECISION MADE: 02-APR-99 CANASTOTA, NY 13032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50 DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K990754(TRADITIONAL) ATTN: KAREN CALLBECK PHONE NO : 902 566 1396 16 MCCARVILLE STREET SE DECISION MADE: 20-APR-99 WEST ROYALTY INDUSTRIAL PARK 510(k) STATEMENT CHARLOTTETOWN, P.E.I., CANADA C1E 2A6 DEVICE: IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5 DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K990886(SPECIAL) ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200 5700 WEST 96TH ST. SE DECISION MADE: 06-APR-99 LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5 DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K991277(SPECIAL) ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200 5700 WEST 96TH ST. SE DECISION MADE: 27-APR-99 LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPQ TEST SYSTEM DIASORIN 510(k) NO: K982708(TRADITIONAL) ATTN: JUDITH J SMITH PHONE NO : 301-497-0005 9175 GUIFORD ROAD SE DECISION MADE: 02-APR-99 COLUMBIA, MD 21046 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DICOM IMAGE MANAGER, MODEL 3-D VISUALIZATION OPTION DICOMIT IMAGING SYSTEMS CORP. 510(k) NO: K990248(TRADITIONAL) ATTN: TERRY CALLAHAN PHONE NO : 905 886 9496 75 EAST BEAVER CREEK RD., #9 SE DECISION MADE: 16-APR-99 RICHMOND HILL, ONTARIO, CANADA L4B510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUMEX IODOFORM PACKING STRIP DUMEX MEDICAL SURGICAL PRODUCTS, L510(k) NO: K990332(TRADITIONAL) ATTN: SHARMINI ATHERAY PHONE NO : 416 299 4003EXT245 104 SHORTING RD. SE DECISION MADE: 14-APR-99 SCARBOROUGH, ONTARIO, CANADA M1S 3510(k) STATEMENT DEVICE: DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851 DYNAMIC TECHNOLOGY CORP. 510(k) NO: K982134(TRADITIONAL) ATTN: YAW C YANG PHONE NO : 863-578-9566 SCIENCE-BASED INDUSTRIAL PARK SE DECISION MADE: 14-APR-99 HSINCHU, CHINA (TAIWAN) R.O.C. 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111 DYNAMIC TECHNOLOGY CORP. 510(k) NO: K990159(TRADITIONAL) ATTN: YAW C YANG PHONE NO : SCIENCE-BASED INDUSTRIAL PARK SE DECISION MADE: 19-APR-99 HSINCHU, CHINA (TAIWAN) R.O.C. 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXPLUG EAGLE VISION, INC. 510(k) NO: K991130(SPECIAL) ATTN: JIM BARLEY PHONE NO : 949-364-9349 6263 POPLAR AVE., SUITE 650 SE DECISION MADE: 20-APR-99 MEMPHIS, TN 38119 510(k) STATEMENT DEVICE: ELASTYLON POWDER-FREE SURGICAL GLOVE ECI MEDICAL TECHNOLOGIES, INC. 510(k) NO: K984337(TRADITIONAL) ATTN: STEPHEN L THOMPSON PHONE NO : 902 541 1225 2 COOK RD. SE DECISION MADE: 09-APR-99 BRIDGEWATER, NOVA SCOTIA, CANADA B510(k) STATEMENT DEVICE: EBI OMEGA 21 SYSTEM ELECTRO-BIOLOGY, INC. 510(k) NO: K990303(TRADITIONAL) ATTN: JON CAPAROTTA PHONE NO : 973-299-9300 100 INTERPACE PKWY. SE DECISION MADE: 29-APR-99 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBI VUECATH ENDOSCOPIC SYSTEN ELECTRO-BIOLOGY, INC. 510(k) NO: K990459(TRADITIONAL) ATTN: JON CAPAROTTA PHONE NO : 973-299-9022 100 INTERPACE PKWY. SE DECISION MADE: 23-APR-99 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION OF: EBI SPINELINK SYSTEM ELECTRO-BIOLOGY, INC. 510(k) NO: K990999(SPECIAL) ATTN: JONAS WILF PHONE NO : 973-299-9022 100 INTERPACE PKWY. SE DECISION MADE: 14-APR-99 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM ELECTRO-BIOLOGY, INC. 510(k) NO: K991092(SPECIAL) ATTN: JONAS WILF PHONE NO : 973-299-9022 100 INTERPACE PKWY. SE DECISION MADE: 29-APR-99 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REHCOR ELECTROMED CORP. 510(k) NO: K990813(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO 7007 SE DECISION MADE: 12-APR-99 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIEW COM ELECTROMED MEDICAL DEVICES CORP. 510(k) NO: K990759(ABBREVIATED) ATTN: PASCAL M KAUFMANN PHONE NO : 450 491 2100 310 INDUSTRIAL SE DECISION MADE: 15-APR-99 ST-EUSTACHE, CANADA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENSITE 3000 SYSTEM ENDOCARDIAL SOLUTIONS, INC. 510(k) NO: K983456(TRADITIONAL) ATTN: ANDREW BALO PHONE NO : 651-523-6924 1350 ENERGY LN., SUITE 110 SE DECISION MADE: 21-APR-99 ST. PAUL, MN 55108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BUECHEL-PAPPAS MODULAR SALVAGE STEM ENDOTEC, INC. 510(k) NO: K982418(ABBREVIATED) ATTN: GEORGE MAKRIS PHONE NO : 973-762-0095 20 VALLEY STREET SE DECISION MADE: 29-APR-99 SOUTH ORANGE, NJ 07079 510(k) STATEMENT DEVICE: EMS MOUTH TO MASK RESUSCITATORS ENGINEERED MEDICAL SYSTEMS 510(k) NO: K983919(TRADITIONAL) ATTN: JEFF QUINN PHONE NO : 317-872-5500 8529 ZIONSVILLE RD. SE DECISION MADE: 07-APR-99 INDIANAPOLIS, IN 46268 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERICHEK TOTAL CHLORINE TEST KIT ENVIRONMENTAL TEST SYSTEMS, INC. 510(k) NO: K983997(TRADITIONAL) ATTN: BRUCE G PIEKARSKI PHONE NO : 219-262-2060 P.O. BOX 4659 SE DECISION MADE: 02-APR-99 ELKHART, IN 46514-0659 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETE EPIC MEDICAL EQUIPMENT SERVICES IN510(k) NO: K990082(TRADITIONAL) ATTN: JEFFREY SECUNDA PHONE NO : 972-801-9854 1800 10TH ST., SUITE 300 SE DECISION MADE: 09-APR-99 PLANO, TX 75074 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAVIT LC ESPE DENTAL AG 510(k) NO: K990982(TRADITIONAL) ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1521395 ESPE PLATZ SE DECISION MADE: 23-APR-99 SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE ETHICON ENDO-SURGERY, INC. 510(k) NO: K990028(TRADITIONAL) ATTN: CHUCK TABRI PHONE NO : 513-483-3532 4545 CREEK RD. SE DECISION MADE: 01-APR-99 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUA EVENFLO CO., INC. 510(k) NO: K983776(TRADITIONAL) ATTN: DONALD E SEGAL PHONE NO : 202-887-4055 1333 NEW HAMPSHIRE AVE., N.W. SE DECISION MADE: 26-APR-99 SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20036 DEVICE: S.P.A.R STERILE AMBULATORY RESERVOIR FAULDING PHARMACEUTICAL CO. 510(k) NO: K990091(TRADITIONAL) ATTN: HEIKE MAASER PHONE NO : 908-931-3806 11 COMMERCE DRIVE SE DECISION MADE: 04-APR-99 CRANFORD, NJ 07016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER FERRIS MFG. CORP. 510(k) NO: K990906(TRADITIONAL) ATTN: THEODORE R THORSON PHONE NO : 630-887-9797 16 WEST 300 83RD ST. SE DECISION MADE: 29-APR-99 BURR RIDGE, IL 60521 510(k) STATEMENT DEVICE: ATLAS-ELITE,MODEL E-80,CORIUM 200,CORIUM 400, MODEL E-90, ELITE, FISMA, INC. 510(k) NO: K990174(TRADITIONAL) ATTN: TRACY S BEST PHONE NO : 801-972-0500 3959 WEST 1820 SOUTH SE DECISION MADE: 01-APR-99 SALT LAKE CITY, UT 84104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES FLEXITECH SDN. BHD. 510(k) NO: K990495(TRADITIONAL) ATTN: KENNY H.N. LIEW PHONE NO : 603 392 0188 LOT 5071, BATU 5 1/2, JALAN SE DECISION MADE: 02-APR-99 MERU 510(k) STATEMENT KLANG, SELANGOR, MALAYSIA 41050 DEVICE: PREPOWDERED NITRILE EXAMINATION GLOVES FLEXITECH SDN. BHD. 510(k) NO: K990499(TRADITIONAL) ATTN: KENNY H. N. LIEW PHONE NO : 603 392 0188 LOT 5071, BATU 5 1/2, JALAN SE DECISION MADE: 02-APR-99 MERU 510(k) STATEMENT KLANG, SELANGOR, MALAYSIA 41050 DEVICE: POWDER FREE LATEX EXAMINATION GLOVES, W/ PROTEIN LABELING CLAIM FLEXITECH SDN. BHD. 510(k) NO: K990501(TRADITIONAL) ATTN: TU AH KIM PHONE NO : 603 392 0188 LOT 5071, BATU 5 1/2, JALAN SE DECISION MADE: 02-APR-99 MERU 510(k) STATEMENT KLANG, SELANGOR, MALAYSIA 41050 DEVICE: PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELI FLEXITECH SDN. BHD. 510(k) NO: K990502(TRADITIONAL) ATTN: KENNY H. N. LIEW PHONE NO : 603 392 0118 LOT 5071, BATU 5 1/2, JALAN SE DECISION MADE: 02-APR-99 MERU 510(k) STATEMENT KLANG, SELANGOR, MALAYSIA 41050 DEVICE: SMARTBOND G.A.C. INTL., INC. 510(k) NO: K981036(TRADITIONAL) ATTN: MARK MANNI PHONE NO : 315-582-5700 185 OVAL DR. SE DECISION MADE: 05-APR-99 CENTRAL ISLIP, NY 11722 510(k) STATEMENT DEVICE: COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS GAMBRO HEALTHCARE 510(k) NO: K982413(TRADITIONAL) ATTN: JEFFREY R SHIDEMAN PHONE NO : 612-835-4018 1185 OAK ST. SE DECISION MADE: 21-APR-99 LAKEWOOD, CO 80215-4498 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR GEREONICS, INC. 510(k) NO: K991411(TRADITIONAL) ATTN: GERALD A ROST PHONE NO : 760-731-9003 4650-143 DULIN ROAD SE DECISION MADE: 28-APR-99 FALLBROOK, CA 92028 510(k) STATEMENT DEVICE: GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH GLOBAL HEALTHCARE, INC. 510(k) NO: K990567(TRADITIONAL) ATTN: ALAM AHMED PHONE NO : 770-522-7520 130 BRANTLEY RD. SE DECISION MADE: 05-APR-99 ATLANTA, GA 30350 510(k) STATEMENT DEVICE: GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58 GUIDANT CORP. 510(k) NO: K991032(SPECIAL) ATTN: KOBBY DANKWAH PHONE NO : 408-235-4174 3200 LAKESIDE DR. SE DECISION MADE: 30-APR-99 P.O. BOX 58167 510(k) SUMMARY AVAILABLE FROM FDA SANTA CLARA, CA 95052-8167 DEVICE: HI-TORQUE BALANCE TREK GUIDE WIRE GUIDANT CORP. 510(k) NO: K991152(SPECIAL) ATTN: MARGARET ANDERSON PHONE NO : 408-235-3995 3200 LAKESIDE DR. SE DECISION MADE: 29-APR-99 P.O. BOX 58167 510(k) SUMMARY AVAILABLE FROM FDA SANTA CLARA, CA 95054-2807 DEVICE: EXTRACORPOREAL BLOOD CIRCUIT HAIDYLENA MEDICAL EGYPT 510(k) NO: K982340(TRADITIONAL) ATTN: SAMEH TAMIM PHONE NO : 002 022 750513 26, MAKRAM EBEID ST. SE DECISION MADE: 30-APR-99 NASR CITY, CAIRO, EGYPT 510(k) STATEMENT DEVICE: SMARTCELL PROCESSING SYSTEM HARVEST TECHNOLOGIES, LLC 510(k) NO: K983022(TRADITIONAL) ATTN: RICHARD LARIVIERE PHONE NO : 781-982-1900 77 ACCORD PARK DR., D-7 SE DECISION MADE: 02-APR-99 NORWELL, MA 02061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRACER HEARTLAND MEDICAL SYSTEMS INC. 510(k) NO: K982617(TRADITIONAL) ATTN: JOHN A HUMPHREY PHONE NO : 805-498-4379 725 PICKFORD CT. SE DECISION MADE: 09-APR-99 NEWBURY PARK, CA 91320 510(k) STATEMENT DEVICE: QUICKDRAW VENOUS CANNULA HEARTPORT, INC. 510(k) NO: K981995(TRADITIONAL) ATTN: MARIANNE C DRENNAN PHONE NO : 650-482-4405 200 CHESAPEAKE DR. SE DECISION MADE: 20-APR-99 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HP M2376A DEVICE LINK SYSTEM HEWLETT-PACKARD CO. 510(k) NO: K984194(TRADITIONAL) ATTN: MIKE HUDON PHONE NO : 978-687-1501 3000 MINUTEMAN RD. SE DECISION MADE: 30-APR-99 ANDOVER, MA 01810-1085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP HEWLETT-PACKARD GMBH 510(k) NO: K990972(SPECIAL) ATTN: EGON PFEIL PHONE NO : 703-114-2243 HERRENBERGER STR. 110-140 SE DECISION MADE: 19-APR-99 BOEBLINGEN, GERMANY 71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WOUND DRESSING/ABD PAD, MODEL #10810 HOSPITAL SPECIALTY CO. 510(k) NO: K990861(TRADITIONAL) ATTN: JOHN QUIGLEY PHONE NO : 216-361-1230 7501 CARNEGIE AVENUE SE DECISION MADE: 12-APR-99 CLEVELAND, OH 44103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIDEKICK INFUSION KIT I-FLOW CORP. 510(k) NO: K990425(TRADITIONAL) ATTN: ROBERT J BARD PHONE NO : 949-206-2700 20202 WINDROW DR. SE DECISION MADE: 23-APR-99 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BI-DIRECTIONAL TUNNELER IMPRA, INC. 510(k) NO: K991027(SPECIAL) ATTN: KRISTI M KISTNER PHONE NO : 480-894-9515 1625 WEST 3RD ST SE DECISION MADE: 22-APR-99 P.O. BOX 1740 510(k) SUMMARY AVAILABLE FROM FDA TEMPE, AZ 85280-1740 DEVICE: MODIFICATION TO IMTEC SENDAX MDI IMTEC CORP. 510(k) NO: K990983(SPECIAL) ATTN: M.K. PATTERSON PHONE NO : 580-223-4456 2401 NORTH COMMERCE SE DECISION MADE: 13-APR-99 ARDMORE, OK 73401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTA LITE LYME IGG ELISA INOVA DIAGNOSTICS, INC. 510(k) NO: K984222(TRADITIONAL) ATTN: BRYS C MYERS PHONE NO : 619-586-9900 10180 SCRIPPS RANCH BLVD. SE DECISION MADE: 15-APR-99 SAN DIEGO, CA 92131 510(k) STATEMENT DEVICE: QUANTA LITE LYME IGM ELISA INOVA DIAGNOSTICS, INC. 510(k) NO: K984234(TRADITIONAL) ATTN: BRYS C MYERS PHONE NO : 619-586-9900 10180 SCRIPPS RANCH BLVD. SE DECISION MADE: 15-APR-99 SAN DIEGO, CA 92131 510(k) STATEMENT DEVICE: IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CON INSTRUMENTATION LABORATORY CO. 510(k) NO: K990302(TRADITIONAL) ATTN: CAROL MARBLE PHONE NO : 781-861-4467 113 HARTWELL AVE SE DECISION MADE: 08-APR-99 LEXINGTON, MA 02173 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECTRA VU 1000 SERIES INTRAORAL CAMERA, SPECTRA VU 2000 SERIES INTERNATIONAL TECHNOLOGY CONCEPTS 510(k) NO: K984332(TRADITIONAL) ATTN: AUSTIN BREWIN PHONE NO : 510-547-1211 6114 LASALLE AVE SE DECISION MADE: 29-APR-99 SUITE 330 510(k) SUMMARY AVAILABLE FROM FDA OAKLAND, CA 94611 DEVICE: CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, INTERSURGICAL, INC. 510(k) NO: K983610(TRADITIONAL) ATTN: THOMAS R GUNERMAN PHONE NO : 315-451-2900 417 ELECTRONICS PKWY. SE DECISION MADE: 30-APR-99 LIVERPOOL, NY 13088 510(k) STATEMENT DEVICE: HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE INTL. TECHNIDYNE CORP. 510(k) NO: K990449(TRADITIONAL) ATTN: JOHN CLAY PHONE NO : 732-548-5700 6 OLSEN AVE. SE DECISION MADE: 13-APR-99 EDISON, NJ 08820 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65 INTRATHERAPEUTICS, INC. 510(k) NO: K981191(TRADITIONAL) ATTN: AMY PETERSON PHONE NO : 612-697-2076 651 CAMPUS DR. SE DECISION MADE: 07-APR-99 ST. PAUL, MN 55112-3495 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM, MODEL SVS-1 INTUITIVE SURGICAL, INC. 510(k) NO: K990188(TRADITIONAL) ATTN: JOHN N ZORICH, JR. PHONE NO : 650-237-7195 1340 W. MIDDLEFIELD ROAD SE DECISION MADE: 01-APR-99 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHETIC SERUM SUBSTITUTE (SSS) IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K983579(TRADITIONAL) ATTN: ROBERTA L JOHNSON PHONE NO : 800-437-5706 2511 DAIMLER ST. SE DECISION MADE: 23-APR-99 SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPERM WASHING MEDIUM, MODIFIED SPERM WASHING MEDIUM IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K983588(TRADITIONAL) ATTN: ROBERTA L JOHNSON PHONE NO : 800-437-5706 2511 DAIMLER ST. SE DECISION MADE: 26-APR-99 SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IPS D.SIGN PORCELAIN IVOCLAR NORTH AMERICA, INC. 510(k) NO: K990817(TRADITIONAL) ATTN: PETER P MANCUSO PHONE NO : 716-691-0010 175 PINEVIEW DR. SE DECISION MADE: 06-APR-99 AMHERST, NY 14228 510(k) STATEMENT DEVICE: BARRIER SURGICAL GOWNS JOHNSON & JOHNSON MEDICAL, DIV. OF510(k) NO: K990395(TRADITIONAL) ATTN: JANE ANN MARTIN PHONE NO : 817-262-4048 2500 EAST ARBROOK BLVD. SE DECISION MADE: 13-APR-99 ARLINGTON, TX 76014-3631 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUICKRAY DSX 730 JULIE ALLIANCE 510(k) NO: K990002(TRADITIONAL) ATTN: CLAUDE D BERHOIN PHONE NO : 904-254-5099 1095 MASON AVE SE DECISION MADE: 01-APR-99 DAYTONA BEACH, FL 32117 510(k) STATEMENT DEVICE: DCI ENDOSCOPE KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K990004(TRADITIONAL) ATTN: KEVIN A KENNAN PHONE NO : 800-421-0837 600 CORPORATE POINTE SE DECISION MADE: 02-APR-99 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYDRO-CAST ACRYLIC VARNISH, MODEL 78125 KAY SEE DENTAL MFG. CO. 510(k) NO: K991161(TRADITIONAL) ATTN: CLARK SMITH PHONE NO : 816-842-2817 124 EAST MISSOURI AVE. SE DECISION MADE: 29-APR-99 KANSAS CITY, MO 64106-1294 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COWBOY XV KCI NEW TECHNOLOGIES INC. 510(k) NO: K981311(TRADITIONAL) ATTN: JUDITH HARBOUR PHONE NO : 210-255-4468 8023 VANTAGE DR. SE DECISION MADE: 23-APR-99 SAN ANTONIO, TX 78230-4726 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KENSTONE KENDA USA 510(k) NO: K990139(TRADITIONAL) ATTN: LONNIE WELLS PHONE NO : 614-866-9803 7095 AMERICANA PARKWAY SE DECISION MADE: 29-APR-99 PO BOX 0132 510(k) SUMMARY AVAILABLE FROM FDA REYNOLDSBURG, OH 43068-4118 DEVICE: KERAVISION VACUUM RING SYSTEM KERAVISION, INC. 510(k) NO: K984540(ABBREVIATED) ATTN: HOWARD H HOLSTEIN PHONE NO : 202-637-5813 555 THIRTEENTH STREET, N.W. SE DECISION MADE: 28-APR-99 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET LABTICIAN OPHTHALMICS, INC. 510(k) NO: K990224(TRADITIONAL) ATTN: R. DAVID SCULATI PHONE NO : 905 829 0055 2140 WINSTON PARK DR., UNIT 6 SE DECISION MADE: 12-APR-99 OAKVILLE, ONTARIO, CANADA L6H 5V5 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS "PEIOLAS LARES RESEARCH, INC. 510(k) NO: K983524(TRADITIONAL) ATTN: THOMAS H LOUISELL PHONE NO : 530-345-1767 295 LOCKHEED AVE. SE DECISION MADE: 01-APR-99 CHICO, CA 95973 510(k) STATEMENT DEVICE: ROTORBLADE LI MEDICAL TECHNOLOGIES, INC. 510(k) NO: K983435(ABBREVIATED) ATTN: RHODEMANN LI PHONE NO : 203-944-2800 4 ARMSTRONG RD. SE DECISION MADE: 29-APR-99 SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IN TOUCH DIABETES MANAGEMENT SOFTWARE LIFESCAN, INC. 510(k) NO: K984527(TRADITIONAL) ATTN: LORI CONZEN PHONE NO : 408-942-5606 1000 GIBRALTAR DR. SE DECISION MADE: 29-APR-99 MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOPEARL LINVATEC CORP. 510(k) NO: K984171(TRADITIONAL) ATTN: CAROL A WEIDEMAN PHONE NO : 727-399-5334 11311 CONCEPT BLVD. SE DECISION MADE: 29-APR-99 LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LYSTA LC CURING LIGHT, MODEL LC 2500C/BA LYSTA A/S 510(k) NO: K991138(TRADITIONAL) ATTN: GREGERS LYSTAGER PHONE NO : 454 495 3000 GAMMELGAARDSVEJ 102 SE DECISION MADE: 23-APR-99 FARUM, DENMARK DK-3520 510(k) STATEMENT DEVICE: COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER MALLINCKRODT INC. 510(k) NO: K983830(TRADITIONAL) ATTN: TERESA O'SHEA PHONE NO : 314-654-3944 675 MCDONNELL BLVD. SE DECISION MADE: 16-APR-99 ST. LOUIS, MO 63134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHOTOTHERAPY LAMP MEDELA INC. 510(k) NO: K984589(TRADITIONAL) ATTN: BONNIE A BEAVERS PHONE NO : 202-223-5120 4610 PRIME PARKWAY SE DECISION MADE: 20-APR-99 MCHENRY, IL 60050-7005 510(k) STATEMENT DEVICE: MULTI-CURE COMPOSITE CEMENT MEDENTAL INTL. 510(k) NO: K990314(TRADITIONAL) ATTN: DEBRA OLSON PHONE NO : 303-567-2542 1246 CLEAR CREEK RD. SE DECISION MADE: 02-APR-99 EVERGREEN, CO 80434 510(k) STATEMENT DEVICE: MEDEX 3000 SERIES SYRINGE INFUSION PUMP MEDEX, INC. 510(k) NO: K982640(TRADITIONAL) ATTN: CATHY CHENETSKI PHONE NO : 800-529-3932 3637 LACON RD. SE DECISION MADE: 06-APR-99 HILLIARD, OH 43026 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE- MEDI-JECT CORP. 510(k) NO: K991294(SPECIAL) ATTN: PEGGY L HOLLAND PHONE NO : 612-475-7773 161 CHESHIRE LANE, SUITE 100 SE DECISION MADE: 23-APR-99 MINNEAPOLIS, MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816 MEDICA CORP. 510(k) NO: K990971(TRADITIONAL) ATTN: PHOTIOS MAKRIS PHONE NO : 781-275-4892 14 DEANGELO DR. SE DECISION MADE: 27-APR-99 BEDFORD, MA 01730 510(k) STATEMENT DEVICE: MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, M MEDICAL COMPONENTS, INC. 510(k) NO: K974236(TRADITIONAL) ATTN: JEANNE M CUSH PHONE NO : 215-256-4201 1499 DELP DR. SE DECISION MADE: 15-APR-99 HARLEYSVILLE, PA 19438 510(k) STATEMENT DEVICE: PBN DRAINAGE CATHETER GUIDEWIRES MEDICAL DEVICE TECHNOLOGIES, INC. 510(k) NO: K991097(TRADITIONAL) ATTN: KARL SWARTZ PHONE NO : 800-338-0440 3600 S.W. 47TH AVE. SE DECISION MADE: 23-APR-99 GAINESVILLE, FL 32608 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERILE BACK SURGICAL GOWN WITH HAND TOWEL MEDICAL STERILIZATION, INC. 510(k) NO: K984422(TRADITIONAL) ATTN: DAVID MORGANSTERN PHONE NO : 516-496-8822 225 UNDERHILL BLVD. SE DECISION MADE: 02-APR-99 SYOSSET, NY 11791 510(k) STATEMENT DEVICE: SONOACE 6000C DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, ALSO MEDISON AMERICA, INC. 510(k) NO: K990970(TRADITIONAL) ATTN: BOB LEIKER PHONE NO : 925-201-2166 6616 OWENS DR. SE DECISION MADE: 07-APR-99 PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MDILOG, MODEL MDC-512 MEDTRAC TECHNOLOGIES, INC. 510(k) NO: K990185(TRADITIONAL) ATTN: LINDA L NELSON PHONE NO : 303-985-0252 6950 WEST JEFFERSON AVE., #210 SE DECISION MADE: 01-APR-99 LAKEWOOD, CO 80235 510(k) STATEMENT DEVICE: MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805- MEDTRONIC PS MEDICAL 510(k) NO: K990333(TRADITIONAL) ATTN: JEFFREY HENDERSON PHONE NO : 805-968-1546 125 CREMONA DR., SE DECISION MADE: 28-APR-99 UNIVERSITY BUSINESS CENTER 510(k) SUMMARY AVAILABLE FROM FDA GOLETA, CA 93117 DEVICE: MEGA 4 MEGA MOTION, INC. 510(k) NO: K982144(TRADITIONAL) ATTN: PAUL GRONKA PHONE NO : 888-415-1200 P.O. BOX 3744 SE DECISION MADE: 14-APR-99 SCRANTON, PA 18505 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEGA 3 MEGA MOTION, INC. 510(k) NO: K982145(TRADITIONAL) ATTN: PAUL GRONKA PHONE NO : 888-415-1200 P.O. BOX 3744 SE DECISION MADE: 14-APR-99 SCRANTON, PA 18505 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER MIDMARK CORP. 510(k) NO: K990189(TRADITIONAL) ATTN: JAMES RILE PHONE NO : 937-526-8797 60 VISTA DR. SE DECISION MADE: 19-APR-99 VERSAILLES, OH 45380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STAINLESS STEEL NONABSORBABLE SURGICAL SUTURE, USP MILL POND, INC. 510(k) NO: K984151(TRADITIONAL) ATTN: GREGORY E SANCOFF PHONE NO : 603-896-9090 ONE STILES ROAD, SUITE 104 SE DECISION MADE: 28-APR-99 SALEM, NH 03079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: `BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH MILLS BIOPHARMACEUTICALS, INC. 510(k) NO: K984446(TRADITIONAL) ATTN: STANLEY L MILLS PHONE NO : 405-525-3141 120 N.E. 26TH STREET SE DECISION MADE: 16-APR-99 OKLAHOMA CITY, OK 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POINT SETTER MITAKA USA, INC. 510(k) NO: K984355(TRADITIONAL) ATTN: MAX STURGIS PHONE NO : 888-244-6173 2337 LUCKY JOHN DRIVE SE DECISION MADE: 01-APR-99 PARK CITY, UT 84060 510(k) STATEMENT DEVICE: SECOND WIND AIR PURIFIER MONAGAN ENT., INC. 510(k) NO: K980745(TRADITIONAL) ATTN: GERALD C MONAGAN PHONE NO : 716-589-9201 14247 RIDGE RD. SE DECISION MADE: 02-APR-99 ALBION, NY 14411 510(k) STATEMENT DEVICE: TRX-CG POWER TILT AND RECLINE SYSTEM MOTION CONCEPTS 510(k) NO: K990544(TRADITIONAL) ATTN: ALLAN BOYD PHONE NO : 416 751 0400 101 BARTLEY DRIVE SE DECISION MADE: 08-APR-99 TORONTO, ONTARIO, CANADA M4A 1C9 510(k) STATEMENT DEVICE: MSB (ELECTRICAL STIMULATION) ELECTRODES (DISPOSABLE). (TENS/FES/ MSB,UK 510(k) NO: K990370(TRADITIONAL) ATTN: PHONE NO : BROOKSIDE COTTAGE,RAMSBURY SE DECISION MADE: 12-APR-99 MARLBOROUGH,WILTSHIRE, UNITED KING510(k) STATEMENT DEVICE: NELLCOR PURITAN BENNETT, GOODKNIGHT 418G NELLCOR PURITAN BENNETT FRANCE DVP510(k) NO: K991150(SPECIAL) ATTN: MOUSTAFA ANKI PHONE NO : 333 834 48500 10 ALLEE PELLETIER DOISY SE DECISION MADE: 14-APR-99 VILLERS-LES-NANCY, FRANCE 54600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BOLD SCREW NEWDEAL S.A. 510(k) NO: K990622(TRADITIONAL) ATTN: NORMAN F ESTRIN PHONE NO : 301-279-2899 9109 COPENHAVER DRIVE SE DECISION MADE: 29-APR-99 POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES NIHON KOHDEN, INC. 510(k) NO: K984504(TRADITIONAL) ATTN: GARY REASONER PHONE NO : 949-250-3959 2601 CAMPUS DR. SE DECISION MADE: 15-APR-99 IRVINE, CA 92612-1601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORI NIHON KOHDEN, INC. 510(k) NO: K990031(TRADITIONAL) ATTN: GARY REASONER PHONE NO : 714-250-3959 2601 CAMPUS DR. SE DECISION MADE: 16-APR-99 IRVINE, CA 92612-1601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S-38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, THE ESSTECH PS NISSEL LTD. 510(k) NO: K990281(TRADITIONAL) ATTN: JOHN M SZABOCSIK PHONE NO : 312-553-0828 203 NORTH WABASH AVENUE SE DECISION MADE: 16-APR-99 SUITE 1200 510(k) SUMMARY AVAILABLE FROM FDA CHICAGO, IL 60601 DEVICE: RSI PROCESS CHALLENGE DEVICE FOR MONITORING STEAM STERILIZATION NORTH AMERICAN SCIENCE ASSOC., INC510(k) NO: K983451(TRADITIONAL) ATTN: MATTHEW SLIVA PHONE NO : 419-666-9455 2261 TRACY RD. SE DECISION MADE: 23-APR-99 NORTHWOOD, OH 43619 510(k) STATEMENT DEVICE: TREATMENT CONTROL STATION - MICROSELECTRON-HDR CLASSIC UPGRADE, NUCLETRON CORP. 510(k) NO: K983115(TRADITIONAL) ATTN: RALPH SHUPING PHONE NO : 410-312-4100 7080 COLUMBIA GATEWAY DR. SE DECISION MADE: 02-APR-99 COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROTTERDAM NASOPHAYRNX MOULD SET, PART #089.068 NUCLETRON CORP. 510(k) NO: K983337(TRADITIONAL) ATTN: RALPH E SHUPING PHONE NO : 410-312-4100 7080 COLUMBIA GATEWAY DR. SE DECISION MADE: 02-APR-99 COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FREIBURG FLAP APPLICATOR SET, PART NUMBER 089.095 NUCLETRON CORP. 510(k) NO: K983338(TRADITIONAL) ATTN: RALPH E SHUPING PHONE NO : 410-312-4100 7080 COLUMBIA GATEWAY DR. SE DECISION MADE: 20-APR-99 COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STANDARD CT/MR APPLICATOR SET,RING CT/MR APPLICATOR SET, VAGINAL NUCLETRON CORP. 510(k) NO: K983341(TRADITIONAL) ATTN: RALPH E SHUPING PHONE NO : 410-312-4100 7080 COLUMBIA GATEWAY DR. SE DECISION MADE: 15-APR-99 COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLATO BRACHYTHERAPHY, MODEL V. 14.0 NUCLETRON CORP. 510(k) NO: K983343(TRADITIONAL) ATTN: RALPH E SHUPING PHONE NO : 410-312-4100 7080 COLUMBIA GATEWAY DR. SE DECISION MADE: 02-APR-99 COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CA O-TWO SYSTEMS INTL., INC. 510(k) NO: K991195(SPECIAL) ATTN: KEVIN BOWDEN PHONE NO : 905 677 9410 7575 KIMBEL ST., UNIT 5 SE DECISION MADE: 22-APR-99 MISSISSAUGA, ONTARIO, CANADA L5S 1510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DI-RHEX OPHTHALMIC DIATHERMY SYSTEM OPHTHALMIC TECHNOLOGIES, INC. 510(k) NO: K990064(TRADITIONAL) ATTN: GEORGE MYERS PHONE NO : 201-727-1703 37 KODIAK CRESCENT, SE DECISION MADE: 04-APR-99 UNIT 12 510(k) SUMMARY AVAILABLE FROM FDA DOWNSVIEW, ONTARIO, CANADA MEJ 3E5 DEVICE: DERMACOOL OPTOMED, INC. 510(k) NO: K990417(TRADITIONAL) ATTN: SHAHRIAR GHAFFARI PHONE NO : 512-335-0000 13091 POND SPRINGS RD., #C-250 SE DECISION MADE: 14-APR-99 AUSTIN, TX 78729 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERS ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K990984(TRADITIONAL) ATTN: ANNE ZAVERTNIK PHONE NO : 716-453-3790 100 INDIGO CREEK DR. SE DECISION MADE: 08-APR-99 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMEGA II MODULAR TOTAL HIP SYSTEM OSTEOIMPLANT TECHNOLOGY, INC. 510(k) NO: K984227(TRADITIONAL) ATTN: SAM SON PHONE NO : 410-785-0700 11201 PEPPER RD. SE DECISION MADE: 08-APR-99 HUNT VALLEY, MD 21031-1201 510(k) STATEMENT DEVICE: OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY OSTEONICS CORP. 510(k) NO: K984375(TRADITIONAL) ATTN: MARYBETH NAUGHTON PHONE NO : 201-934-4346 59 ROUTE 17 SE DECISION MADE: 30-APR-99 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TROVAFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD. 510(k) NO: K984513(TRADITIONAL) ATTN: ANDY HOLLINGSWORTH PHONE NO : 44 125 6841144 WADE ROAD SE DECISION MADE: 02-APR-99 RG24 8PW 510(k) STATEMENT BASINGSTOKE,HANTS, UNITED KINGDOM RG24 8PW DEVICE: PVS BASICS PARAGON VISION SCIENCES 510(k) NO: K984436(TRADITIONAL) ATTN: WILLIAM E MEYERS PHONE NO : 602-507-7606 947 EAST IMPALA AVE. SE DECISION MADE: 21-APR-99 MESA, AZ 85204 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUICKCARD HCG COMBO TEST, MODEL #9014 PHAMATECH 510(k) NO: K991095(TRADITIONAL) ATTN: CARL MONGIOVI PHONE NO : 619-635-5840 9265 ACTIVITY RD., #112-113 SE DECISION MADE: 28-APR-99 SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRX WORLD SHUNT PHOENIX BIOMEDICAL CORP. 510(k) NO: K990256(SPECIAL) ATTN: COURTNEY SMITH PHONE NO : 610-539-9300 2495 GENERAL ARMSTEAD AVE. SE DECISION MADE: 01-APR-99 NORRISTOWN, PA 19403 510(k) STATEMENT DEVICE: BEACON, MODEL 211060 PICKER INTERNATIOANL, INC. 510(k) NO: K983948(TRADITIONAL) ATTN: PHONE NO : 595 MINER ROAD SE DECISION MADE: 16-APR-99 HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PILLING WECK SURGICAL Y STENT FORCEPS PILLING WECK, INC. 510(k) NO: K990547(TRADITIONAL) ATTN: JULIE A BEAUMONT PHONE NO : 603-532-7706 1 WECK DRIVE SE DECISION MADE: 27-APR-99 RESEARCH TRIANGLE PARK, NC 27709 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERRY HUMERAL NAIL PIONEER LABORATORIES, INC. 510(k) NO: K990322(TRADITIONAL) ATTN: BURNS SEVERSON PHONE NO : 906-226-9909 375 RIVER PARK CIRCLE SE DECISION MADE: 01-APR-99 MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STAYFUSE PIONEER LABORATORIES, INC. 510(k) NO: K990804(TRADITIONAL) ATTN: BURNS SEVERSON PHONE NO : 906-226-9909 375 RIVER PARK CIRCLE SE DECISION MADE: 29-APR-99 MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZFLOW CONTINUOUS NEBULIZER,MODEL 1005 PIPER MEDICAL PRODUCTS 510(k) NO: K990384(TRADITIONAL) ATTN: SAMUEL DAVID PIPER, PE PHONE NO : 916-375-0112 4007 SEAPORT BLVD. SE DECISION MADE: 26-APR-99 WEST SACRAMENTO, CA 95691 510(k) STATEMENT DEVICE: DIABETIC NEEDLE DISPOSAL, MODEL # PMSM - 950 POST MEDICAL, INC. 510(k) NO: K990371(TRADITIONAL) ATTN: DAVID R THEAD PHONE NO : 770-928-4100 P.O. BOX 29863 SE DECISION MADE: 21-APR-99 ATLTANTA, GA 30359 510(k) STATEMENT DEVICE: 'ECURLINE UMBILICAL CORD CLAMP #3500 PRECISION DYNAMICS CORP. 510(k) NO: K990737(TRADITIONAL) ATTN: KALYNA SNYLYK PHONE NO : 818-897-1111 13880 DEL SUR ST. SE DECISION MADE: 06-APR-99 SAN FERNANDO, CA 91340-3490 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUSIGN BAR, BIOSIGN BAR, STATUS BAR PRINCETON BIOMEDITECH CORP. 510(k) NO: K991018(SPECIAL) ATTN: JEMO KANG PHONE NO : 800-726-2670 4242 U.S. ROUTE 1 SE DECISION MADE: 15-APR-99 P.O. BOX 7139 510(k) STATEMENT MONMOUTH JUNCTION, NJ 08852-1905 DEVICE: ACCUSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA3, DOA PRINCETON BIOMEDITECH CORP. 510(k) NO: K991076(SPECIAL) ATTN: JEMO KANG PHONE NO : 800-726-2670 4242 U.S. ROUTE 1 SE DECISION MADE: 15-APR-99 P.O. BOX 7139 510(k) STATEMENT MONMOUTH JUNCTION, NJ 08852-1905 DEVICE: ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOS PRINCETON BIOMEDITECH CORP. 510(k) NO: K991078(SPECIAL) ATTN: JEMO KANG PHONE NO : 800-726-2670 4242 U.S. ROUTE 1 SE DECISION MADE: 15-APR-99 P.O. BOX 7139 510(k) STATEMENT MONMOUTH JUNCTION, NJ 08852-1905 DEVICE: ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO PRINCETON BIOMEDITECH CORP. 510(k) NO: K991079(SPECIAL) ATTN: JEMO KANG PHONE NO : 800-726-2670 4242 U.S. ROUTE 1 SE DECISION MADE: 15-APR-99 P.O. BOX 7139 510(k) STATEMENT MONMOUTH JUNCTION, NJ 08852-1905 DEVICE: ACCUSIGN MTD, BIOSIGN MTD PRINCETON BIOMEDITECH CORP. 510(k) NO: K991080(SPECIAL) ATTN: JEMO KANG PHONE NO : 800-726-2670 4242 U.S. ROUTE 1 SE DECISION MADE: 15-APR-99 P.O. BOX 7139 510(k) STATEMENT MONMOUTH JUNCTION, NJ 08852-1905 DEVICE: ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BA PRINCETON BIOMEDITECH CORP. 510(k) NO: K991082(SPECIAL) ATTN: JEMO KANG PHONE NO : 800-726-2670 4242 U.S. ROUTE 1 SE DECISION MADE: 15-APR-99 P.O. BOX 7139 510(k) STATEMENT MONMOUTH JUNCTION, NJ 08852-1905 DEVICE: ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/M PRINCETON BIOMEDITECH CORP. 510(k) NO: K991084(SPECIAL) ATTN: JEMO KANG PHONE NO : 800-726-2670 4242 U.S. ROUTE 1 SE DECISION MADE: 15-APR-99 P.O. BOX 7139 510(k) STATEMENT MONMOUTH JUNCTION, NJ 08852-1905 DEVICE: LTV 1000 PULMONETIC SYSTEMS, INC. 510(k) NO: K984056(TRADITIONAL) ATTN: DOUGLAS F DEVRIES PHONE NO : 909-783-2280 930 S. MT. VERNON AVE. SE DECISION MADE: 12-APR-99 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA COLTON, CA 92324 DEVICE: QUINTON MEDTRACK CR PLUS TREADMILL QUINTON INSTRUMENT CO. 510(k) NO: K990866(TRADITIONAL) ATTN: MATTHEW J HEDLUND PHONE NO : 425-402-2416 3303 MONTE VILLA PKWY. SE DECISION MADE: 29-APR-99 BOTHELL, WA 98021-8906 510(k) STATEMENT DEVICE: RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER W RADIONICS, INC. 510(k) NO: K980903(TRADITIONAL) ATTN: MICHAEL A ARNOLD, PH.D PHONE NO : 781-272-1233 22 TERRY AVE. SE DECISION MADE: 19-APR-99 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTICAL TRACKING SYSTEM (OTS) RADIONICS, INC. 510(k) NO: K990632(TRADITIONAL) ATTN: LISA MISTERKA BENATI PHONE NO : 781-272-1233 22 TERRY AVE. SE DECISION MADE: 29-APR-99 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REDI-TEST THC REDWOOD BIOTECH INC. 510(k) NO: K990870(TRADITIONAL) ATTN: JANIS FREESTONE PHONE NO : 408-541-8970 520 WEDDELL DRIVE, SUITE 8 SE DECISION MADE: 27-APR-99 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTRECORDER, MODEL 2500 RESPIRONICS, INC. 510(k) NO: K990199(TRADITIONAL) ATTN: BETSY CORTELLONI PHONE NO : 770-429-2894 1255 KENNESTONE CIR. SE DECISION MADE: 19-APR-99 MARIETTA, GA 30066 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771, RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K990147(TRADITIONAL) ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113 353 CORPORATE WOODS PKWY. SE DECISION MADE: 16-APR-99 VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8 ROCHE DIAGNOSTICS CORP. 510(k) NO: K990399(TRADITIONAL) ATTN: JENNIFER TRIBBETT PHONE NO : 317-845-2000 9115 HAGUE RD. SE DECISION MADE: 15-APR-99 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K) ROCHE DIAGNOSTICS CORP. 510(k) NO: K990409(TRADITIONAL) ATTN: JENNIFER L TRIBBETT PHONE NO : 317-576-3742 9115 HAGUE RD. SE DECISION MADE: 15-APR-99 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONTRAK TESTCUP-ER M2K ROCHE DIAGNOSTICS CORP. 510(k) NO: K990418(TRADITIONAL) ATTN: JENNIFER L TRIBBETT PHONE NO : 317-576-3742 9115 HAGUE RD. SE DECISION MADE: 13-APR-99 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 ROCHE DIAGNOSTICS CORP. 510(k) NO: K990594(TRADITIONAL) ATTN: PRISCILLA A HAMILL PHONE NO : 317-576-3723 9115 HAGUE RD. SE DECISION MADE: 14-APR-99 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B ROCHE DIAGNOSTICS CORP. 510(k) NO: K990595(TRADITIONAL) ATTN: PRISCILLA A HAMILL PHONE NO : 317-576-3723 9115 HAGUE RD. SE DECISION MADE: 14-APR-99 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE ROSS PRODUCTS, DIV. ABBOTT LABORAT510(k) NO: K990863(SPECIAL) ATTN: DANIEL HAMILTON PHONE NO : 614-624-3743 625 CLEVELAND AVENUE SE DECISION MADE: 06-APR-99 COLUMBUS, OH 43215 510(k) STATEMENT DEVICE: BIOMESH BIODEGRADABLE GTR BARRIER SAMYANG CORP. 510(k) NO: K990363(TRADITIONAL) ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640 200 GREGORY LANE, SUITE C-100 SE DECISION MADE: 09-APR-99 PLEASANT HILL, CA 94523-3389 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: X-TIP INTRAOSSEOUS PERFORATOR SCHIFF & CO. 510(k) NO: K990511(TRADITIONAL) ATTN: ROBERT SCHIFF PHONE NO : 973-227-1830 1129 BLOOMFIELD AVE. SE DECISION MADE: 27-APR-99 WEST CALDWELL, NJ 07006 510(k) STATEMENT DEVICE: SPIROVIT, MODEL SP-250 SCHILLER AG 510(k) NO: K984031(TRADITIONAL) ATTN: MARKUS BUETLER PHONE NO : 041 766 4252 ALTGASSE 68 SE DECISION MADE: 30-APR-99 CH-6340 BAAR, SWITZERLAND 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM SELFCARE, INC. 510(k) NO: K990939(SPECIAL) ATTN: CAROL ADILETTO PHONE NO : 781-647-3900 200 PROSPECT ST. SE DECISION MADE: 20-APR-99 WALTHAM, MA 02154-3457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SERIM BLOOD LEAK TEST STRIP SERIM RESEARCH CORP. 510(k) NO: K990206(TRADITIONAL) ATTN: ROBERT J CARRICO PHONE NO : 219-264-3440 23565 REEDY DRIVE SE DECISION MADE: 21-APR-99 P.O. BOX 4002 510(k) SUMMARY AVAILABLE FROM FDA ELKHART, IN 46514 DEVICE: VISION PORCELAIN SERVO DENTAL USA, INC. 510(k) NO: K990790(TRADITIONAL) ATTN: ANGELIKA RINEHART PHONE NO : 847-205-1778 1770 BIRCH RD. SE DECISION MADE: 02-APR-99 NORTHBROOK, IL 60062-5908 510(k) STATEMENT DEVICE: SHEATHES (NON-LATEX), STERILE SHEATHING TECHNOLOGIES, INC. 510(k) NO: K990175(TRADITIONAL) ATTN: LAWRENCE S POLAYES PHONE NO : 408-977-0144 334 COMMERCIAL ST. SE DECISION MADE: 21-APR-99 SAN JOSE, CA 95112 510(k) STATEMENT DEVICE: SHIMADZU CEILING TUBE SUPPORT CH-30GH SHIMADZU CORP. 510(k) NO: K990715(ABBREVIATED) ATTN: MICHAEL FISHBACK PHONE NO : 310-217-8855 20101 SOUTH VERMONT AVENUE SE DECISION MADE: 16-APR-99 TORRANCE, CA 90502-1328 510(k) STATEMENT DEVICE: SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TX SHIMADZU MEDICAL SYSTEMS 510(k) NO: K984156(TRADITIONAL) ATTN: MICHAEL FISHBACK PHONE NO : 310-217-8855 20101 SOUTH VERMONT AVE. SE DECISION MADE: 21-APR-99 TORRANCE, CA 90502-1328 510(k) STATEMENT DEVICE: THORAX FD AND MULTIX FD SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K983732(TRADITIONAL) ATTN: MALGORZATA STANEK PHONE NO : 732-321-3950 186 WOOD AVENUE SOUTH SE DECISION MADE: 21-APR-99 ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANGIO-CT MIYABI SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K990491(TRADITIONAL) ATTN: ALICIA BUSTOS-JUERGENSEN PHONE NO : 732-321-3243 186 WOOD AVE. SOUTH SE DECISION MADE: 05-APR-99 ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION OF: DAVIDSTRIP HCG SIMEX MEDICAL, INC. 510(k) NO: K991067(TRADITIONAL) ATTN: MICHELLE J HALL PHONE NO : 206-575-2368 560 INDUSTRY DRIVE SE DECISION MADE: 27-APR-99 SEATTLE, WA 98188 510(k) STATEMENT DEVICE: ORTHOPHOS 3/3 CEPH/3 DS SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K990528(TRADITIONAL) ATTN: SHEILA HEMEON-HEYER PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 30-APR-99 NORTH ATTLEBORO, MA 02760 510(k) STATEMENT DEVICE: SMITH & NEPHEW HANDPORT SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K990414(TRADITIONAL) ATTN: AMY L WALTERS PHONE NO : 508-261-3776 130 FORBES BLVD. SE DECISION MADE: 14-APR-99 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S575 INTRAORAL DOCKING DENTAL CAMERA SOPRO 510(k) NO: K990948(TRADITIONAL) ATTN: PIERRE MONTILLOT PHONE NO : 334 912 70727 PLACE ST. CHRISTOPHE SE DECISION MADE: 21-APR-99 LES ACCATES-LA VALENTINE 510(k) SUMMARY AVAILABLE FROM FDA MARSEILLE, FRANCE 13011 DEVICE: KLEENHANDS POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABE SSN GLOVES (M) SDN BHD 510(k) NO: K990526(TRADITIONAL) ATTN: ANG TECK LEONG PHONE NO : 603 441 3488 LOT 147, JALAN SELVADURAI, SE DECISION MADE: 23-APR-99 OFF JALAN IPOH 510(k) STATEMENT KUALA LUMPUR, MALAYSIA 51200 DEVICE: KLEENHANDS POWDERED LATEX EXAMINATION GLOVES SSN GLOVES (M) SDN BHD 510(k) NO: K990527(TRADITIONAL) ATTN: ANG TECK LEONG PHONE NO : 603 441 3488 LOT 147, JALAN SELVADURAI, SE DECISION MADE: 23-APR-99 OFF JALAN IPOH 510(k) STATEMENT KUALA LUMPUR, MALAYSIA 51200 DEVICE: LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM STAR MEDICAL TECHNOLOGIES, INC. 510(k) NO: K982940(TRADITIONAL) ATTN: MARCY MOORE PHONE NO : 919-676-7166 9516 CANDOR OAKS DRIVE SE DECISION MADE: 08-APR-99 RALEIGH, NC 27615 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTI STELLAR BIO SYSTEMS, INC. 510(k) NO: K990915(TRADITIONAL) ATTN: JOHN BREWER PHONE NO : 410-381-8550 9075 GUILFORD RD. SE DECISION MADE: 21-APR-99 COLUMBIA, MD 21046 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY STELLAR BIO SYSTEMS, INC. 510(k) NO: K990916(TRADITIONAL) ATTN: JOHN BREWER PHONE NO : 410-381-8550 9075 GUILFORD RD. SE DECISION MADE: 21-APR-99 COLUMBIA, MD 21046 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRAUMANN EXTRAORAL IMPLANT SYSTEM STRAUMANN USA 510(k) NO: K990458(TRADITIONAL) ATTN: LINDA JALBERT PHONE NO : 800-448-8168 RESERVOIR PLACE, SE DECISION MADE: 16-APR-99 1601 TRAPELO ROAD 510(k) SUMMARY AVAILABLE FROM FDA WALTHAM, MA 02154 DEVICE: OMNI-FIX, NAIL SYSTEM SURGICAL IMPLANTS, INC. 510(k) NO: K990307(TRADITIONAL) ATTN: DOUGLAS W STEWART PHONE NO : 941-366-1882 962 SOUTH TAMIAMI TRAIL, #203 SE DECISION MADE: 01-APR-99 SARASOTA, FL 34326 510(k) STATEMENT DEVICE: B2C, ESPACE REVISION CUP SYSTEM SURGICAL IMPLANTS, INC. 510(k) NO: K990523(TRADITIONAL) ATTN: DOUGLAS W STUART PHONE NO : 941-366-1882 962 SOUTH TAMIAMI TRAIL, #203 SE DECISION MADE: 30-APR-99 SARASOTA, FL 34326 510(k) STATEMENT DEVICE: FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM SURGICAL NAVIGATION TECHNOLOGIES, 510(k) NO: K990214(TRADITIONAL) ATTN: ROGER N WHITE PHONE NO : 303-439-9709 530 COMPTON ST. SE DECISION MADE: 22-APR-99 BROOMFIELD, CO 80020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRODIGY 4 SYBRON DENTAL SPECIALTIES,INC 510(k) NO: K990898(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVENUE SE DECISION MADE: 06-APR-99 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TL250 INTERFERENTIAL/MUSCLE STIMULATOR INTERFERENTIAL CURRENT T THERAPY LINK, INC. 510(k) NO: K990129(TRADITIONAL) ATTN: CRAIG SEYL PHONE NO : 913-851-8993 P.O. BOX 192004 SE DECISION MADE: 12-APR-99 LENEXA, KS 66215 510(k) STATEMENT DEVICE: ULTRA CARE NON-STERILE POWDER FREE (GREEN) NATURAL RUBBER LATEX TILLOTSON HEALTHCARE CORP. 510(k) NO: K982505(TRADITIONAL) ATTN: EDWARD MARKOVIC PHONE NO : 800-445-6830 360 ROUTE 101 SE DECISION MADE: 02-APR-99 BEDFORD, NH 03110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIGHTLY POWDERED LATEX EXAMINATION GLOVE W/ LOW PROTEIN LABELING TOP GLOVE SDN. BHD. 510(k) NO: K990468(TRADITIONAL) ATTN: LIM WEE CHAI PHONE NO : 603 392 1992/1905 41050 KLANG,SELANGOR SE DECISION MADE: 27-APR-99 DARUL EHSAN, MALAYSIA 510(k) STATEMENT DEVICE: TOP WHOLESOME FACE MASK TOP WHOLESOME ENTERPRISE CO., LTD.510(k) NO: K984389(TRADITIONAL) ATTN: URAI CHAROENSUK PHONE NO : 662 748 7899 A.P. NAKARINTR TOWER 18TH FL SE DECISION MADE: 09-APR-99 333 MOO 9, SRINAKARINTR RD. 510(k) STATEMENT BANGNA, THAILAND 10260 DEVICE: OPART, MODEL MRT-600 TOSHIBA AMERICA MRI, INC. 510(k) NO: K990007(TRADITIONAL) ATTN: KEN NEHMER PHONE NO : 650-872-2722 280 UTAH AVE. SE DECISION MADE: 01-APR-99 SOUTH SAN FRANCISCO, CA 94080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPART TOSHIBA AMERICA MRI, INC. 510(k) NO: K990260(TRADITIONAL) ATTN: HSU CHANG PHONE NO : 650-827-2722 280 UTAH AVE. SE DECISION MADE: 15-APR-99 SOUTH SAN FRANCISCO, CA 94080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNI-FLEX RESIN TRANS-ATLANTIC DENTAL 510(k) NO: K983461(TRADITIONAL) ATTN: CAROLINE M ZALESKI PHONE NO : 609-695-0168 46 ARCTIC PKWY. SE DECISION MADE: 13-APR-99 TRENTON, NJ 08638-3041 510(k) STATEMENT DEVICE: ENDOMETRIAL SAMPLER U.A. MEDICAL PRODUCTS, INC. 510(k) NO: K990387(TRADITIONAL) ATTN: FANISH ENGINEER PHONE NO : 704-841-7297 9303-G2 MONROE RD. SE DECISION MADE: 20-APR-99 CHARLOTTE, NC 28270 510(k) STATEMENT DEVICE: CLEARPLAN EASY HOME PREGNANCY TEST UNIPATH LTD. 510(k) NO: K990262(TRADITIONAL) ATTN: LOUISE ROBERTS PHONE NO : 441 234 835564 PRIORY BUSINESS PARK SE DECISION MADE: 07-APR-99 BEDFORD, UNITED KINGDOM MK44 3UP 510(k) STATEMENT DEVICE: KINGLI ACUPUNCTURE NEEDLE UNITED PACIFIC CO., LTD. 510(k) NO: K990406(TRADITIONAL) ATTN: DANIEL YE HUA PHONE NO : 626-458-8518 219 SOUTH RAYMOND AVE. SE DECISION MADE: 16-APR-99 ALHAMBRA, CA 91801 510(k) STATEMENT DEVICE: MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTURE UNITED STATES SURGICAL CORP. 510(k) NO: K990951(TRADITIONAL) ATTN: VICTOR M CLAVELLI PHONE NO : 203-845-4543 150 GLOVER AVE. SE DECISION MADE: 01-APR-99 NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURE UNITED STATES SURGICAL CORP. 510(k) NO: K990952(TRADITIONAL) ATTN: VICTOR M CLAVELLI PHONE NO : 203-845-4543 150 GLOVER AVE. SE DECISION MADE: 01-APR-99 NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PVR-100/VASOGRAM VASOCOR, INC. 510(k) NO: K990123(TRADITIONAL) ATTN: JEFF RAINES PHONE NO : 305-592-7260 7705 N.W. 48TH STREET SE DECISION MADE: 12-APR-99 SUITE 120 510(k) STATEMENT MIAMI, FL 33166 DEVICE: SMARTVENT 201 PORTABLE VENTILATOR VERSAMED LTD. 510(k) NO: K981668(TRADITIONAL) ATTN: SHOSHANA FRIEDMAN PHONE NO : 972 977 18130 117 AHUZAH ST. SE DECISION MADE: 07-APR-99 RA'ANANNA, ISRAEL 43373 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PDQ AND PDQ-TI ABUTMENT VIDENT 510(k) NO: K990367(TRADITIONAL) ATTN: BARBARA J LEWANDOWSKI PHONE NO : 714-961-6200 3150 EAST BIRCH STREET SE DECISION MADE: 21-APR-99 PO BOX 2340 510(k) STATEMENT BREA, CA 92822-2340 DEVICE: VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX VILEX, INC. 510(k) NO: K991151(TRADITIONAL) ATTN: ABRAHIM LAVI PHONE NO : 412-384-7570 1801 RT. 51, BUILDING 10 SE DECISION MADE: 26-APR-99 JEFFERSON HILLS, PA 15025-0724 510(k) STATEMENT DEVICE: VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW, MODELS P222-XX, S25-XX VILEX, INC. 510(k) NO: K991197(TRADITIONAL) ATTN: ABRAHIM LAVI PHONE NO : 412-384-7570 1801 RT. 51, BUILDING 10 SE DECISION MADE: 26-APR-99 JEFFERSON HILLS, PA 15025-0724 510(k) STATEMENT DEVICE: STRAIGHT ASPIRATOR, 90 DEGREE ASPIRATOR,45 DEGREE ASPIRATOR,7 FR VISUALIZATION TECHNOLOGY, INC. 510(k) NO: K990919(SPECIAL) ATTN: PETER OHANIAN PHONE NO : 978-933-1000 200 RESEARCH DR. SE DECISION MADE: 15-APR-99 WILMINGTON, MA 01887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUSEAL CARDIOVASCULAR PATCH W.L. GORE & ASSOC., INC. 510(k) NO: K984526(TRADITIONAL) ATTN: TIMOTHY J RYNN PHONE NO : 800-437-8181 3450 WEST KILTIE LANE SE DECISION MADE: 08-APR-99 P.O. BOX 500 510(k) SUMMARY AVAILABLE FROM FDA FLAGSTAFF, AZ 86002-0500 DEVICE: RAPIDFLAP CRANIAL CLAMP WALTER LORENZ SURGICAL, INC. 510(k) NO: K991029(SPECIAL) ATTN: DIANA PRESTON PHONE NO : 904-741-4400 1520 TRADEPORT DR. SE DECISION MADE: 23-APR-99 JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WATER TREATMENT SYSTEM FOR HEMODIALYSIS WATER VAULT, INC. 510(k) NO: K983512(TRADITIONAL) ATTN: MICHAEL J PETERSON PHONE NO : 615-292-7336 2003 BLAIR BOULEVARD SE DECISION MADE: 28-APR-99 NASHVILLE, TN 37212 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WILTEK HOT BIOPSY FORCEPS WILTEK MEDICAL, INC. 510(k) NO: K990231(TRADITIONAL) ATTN: JON S WILSON PHONE NO : 910-761-1127 101 NORTH CHESTNUT ST., #300 SE DECISION MADE: 13-APR-99 WINSTON-SALEM, NC 27101 510(k) STATEMENT DEVICE: DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVE, NON STERILE (PROT WRP SPECIALTY PRODUCTS SDN. BHD. 510(k) NO: K991044(TRADITIONAL) ATTN: CHENG HEAN KHOO PHONE NO : 603 846 2055 LOT11, JL.2,KAWASAN PERUSAHAAN SE DECISION MADE: 23-APR-99 BANDAR BARU SLAK TINGGI 510(k) SUMMARY AVAILABLE FROM FDA SELANGOR DAURL EHSAN, SEPANG, MALAYSIA 43900 DEVICE: SOF-SUCTION FLUID EVACUATION SYSTEM X-TECH MEDICAL 510(k) NO: K990749(TRADITIONAL) ATTN: EDGAR A RAININ PHONE NO : 925-736-5001 111 WILD OAK COURT SE DECISION MADE: 02-APR-99 DANVILLE, CA 94506 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORLIGHT 2000 SURGICAL LASER SYSTEM YBEAM TECHNOLOGIES, INC. 510(k) NO: K990452(TRADITIONAL) ATTN: JUDY F GORDON PHONE NO : 949-854-6314 18732 SAGINAW SE DECISION MADE: 29-APR-99 IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOLTER 2000 ZYMED MEDICAL INSTRUMENTATION 510(k) NO: K990170(SPECIAL) ATTN: GRETEL LUMLEY PHONE NO : 800-235-5941 20 NORTH AVIADOR STREET SE DECISION MADE: 13-APR-99 CAMARILLO, CA 93010 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 262 TOTAL WITH SUMMARIES 163 TOTAL WITH STATEMENTS 99
Updated 5/5/1999
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