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510(k)s Final Decisions Rendered for May 2000 |
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SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-MAY-2000 THROUGH 31-MAY-2000
DEVICE: 4631 DUO DELIVERY SYSTEM
A-DEC, INC. 510(k) NO: K000966(TRADITIONAL)
ATTN: LOVENA STANDRIDGE PHONE NO : 503-538-9471
2601 CRESTVIEW DR. SE DECISION MADE: 03-MAY-00
NEWBERG, OR 97132-9257 510(k) STATEMENT
DEVICE: 4635 ASSISTANT'S INSTRUMENTATION
A-DEC, INC. 510(k) NO: K000967(TRADITIONAL)
ATTN: LOVENA STANDRIDGE PHONE NO : 503-538-9471
2601 CRESTVIEW DR. SE DECISION MADE: 03-MAY-00
NEWBERG, OR 97132-9257 510(k) STATEMENT
DEVICE: 3181 DUO DELIVERY SYSTEM
A-DEC, INC. 510(k) NO: K000968(TRADITIONAL)
ATTN: LOVENA STANDRIDGE PHONE NO : 503-538-9471
2601 CRESTVIEW DR. SE DECISION MADE: 03-MAY-00
NEWBERG, OR 97132-9257 510(k) STATEMENT
DEVICE: A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000
A-MED SYSTEMS, INC. 510(k) NO: K992592(TRADITIONAL)
ATTN: ROBERTA THOMPSON PHONE NO : 916-375-7400
2491 BOATMAN AVE. SE DECISION MADE: 04-MAY-00
SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETEST MOXIFLOXACIN
AB BIODISK 510(k) NO: K000298(TRADITIONAL)
ATTN: ANNE BOLMSTROM PHONE NO : 468 773 007
DALVAGEN 10 SE DECISION MADE: 18-MAY-00
SOLNA, SWEDEN S-169 56 510(k) STATEMENT
DEVICE: ETEST GATIFLOXACIN
AB BIODISK 510(k) NO: K000596(TRADITIONAL)
ATTN: ANNE BOLMSTROM PHONE NO : 46 873 00760
DALVAGEN 10 SE DECISION MADE: 22-MAY-00
SOLNA, SWEDEN 16956 510(k) STATEMENT
DEVICE: ABBOTT IMX GLYCATED HEMOGLOBIN II
ABBOTT LABORATORIES, INC. 510(k) NO: K992085(TRADITIONAL)
ATTN: KATHERINE M WORTLEY PHONE NO : 847-938-7707
DEPT 9YC, BIDG. AP31 SE DECISION MADE: 25-MAY-00
200 ABBOTT PARK ROAD 510(k) SUMMARY AVAILABLE FROM FDA
ABBOTT PARK, IL 60064-6200
DEVICE: MODIFICATION TO ACIST CL 100H
ACIST MEDICAL SYSTEMS 510(k) NO: K991103(TRADITIONAL)
ATTN: CARL M BEAURLINE PHONE NO : 952-995-9319
7450 FLYING CLOUDS DR. SE DECISION MADE: 31-MAY-00
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
EDEN PRAIRIE, MN 55344
DEVICE: ARACHNOPHLEBECTOMY NEEDLE
ADVANCED MEDICAL PRODUCTS, INC. 510(k) NO: K000932(TRADITIONAL)
ATTN: CHARLES H KYPER PHONE NO : 301-776-3546
11902 SIMPSON ROAD SE DECISION MADE: 17-MAY-00
CLARKSVILLE, MD 21029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CIDEX OPA SOLUTION
ADVANCED STERILIZATION PRODUCTS 510(k) NO: K001381(SPECIAL)
ATTN: NEELU MEDHEKAR PHONE NO : 949-789-3838
33 TECHNOLOGY DR. SE DECISION MADE: 17-MAY-00
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATR TECNIKA
ADVANCED TECHNOLOGY RESEARCH S.A.S510(k) NO: K000547(TRADITIONAL)
ATTN: DANIELE POLI PHONE NO : 390 573 364254
VIA DEL PESCINO, 6 SE DECISION MADE: 03-MAY-00
PISTOIA, ITALY 51100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEART 2005
AEROTEL MEDICAL SYSTEMS (1998) LTD510(k) NO: K000775(SPECIAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377ROUTE 17 S SE DECISION MADE: 17-MAY-00
HASBROUCK HEIGHT, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOVEREIGN BIPOLAR INSTRUMENTS
AESCULAP, INC. 510(k) NO: K001330(TRADITIONAL)
ATTN: LIA S JONES PHONE NO : 650-876-7000
1000 GATEWAY BLVD. SE DECISION MADE: 30-MAY-00
SOUTH SAN FRANCISCO, CA 94080-7028510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AGILENT COMPONENT MONITORING SYSTEM, AGILENT MULTI-MEASUREMENT S
AGILENT TECHNOLOGIES DEUTSCHLAND G510(k) NO: K001333(SPECIAL)
ATTN: EGON PFEIL PHONE NO : 49 703 14642243
HERRENBERGER STRASSE 130 SE DECISION MADE: 17-MAY-00
BOEBLINGEN, 71034, GERMANY 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MOD
AGILENT TECHNOLOGIES, GMBH 510(k) NO: K994188(SPECIAL)
ATTN: HERBERT VAN DYK PHONE NO : 49 703 14642854
HERRENBERGER STRASSE 130 SE DECISION MADE: 19-MAY-00
BOEBLINGEN, GERMANY 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AGILENT INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A AND AG
AGILENT TECHNOLOGIES, INC. 510(k) NO: K001057(SPECIAL)
ATTN: DAVE OSBORN PHONE NO : 978-659-3173
3000 MINUTEMAN RD. SE DECISION MADE: 03-MAY-00
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ST/AR ST AND ARRHYTHMIA SOFTWARE
AGILENT TECHNOLOGIES, INC. 510(k) NO: K001348(SPECIAL)
ATTN: DAVE OSBORN PHONE NO : 978-659-3178
3000 MINUTEMAN RD. SE DECISION MADE: 17-MAY-00
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
AIRSEP CORP. 510(k) NO: K001013(TRADITIONAL)
ATTN: PETER WEISENBORN PHONE NO : 716-691-0202
290 CREEKSIDE DR. SE DECISION MADE: 16-MAY-00
BUFFALO, NY 14228-2070 510(k) STATEMENT
DEVICE: METRISCAN BONE DENSITY SYSTEM
ALARA INC. 510(k) NO: K000162(TRADITIONAL)
ATTN: DIANE M KING PHONE NO : 510-723-0110
2545 BARRINGTON CT. SE DECISION MADE: 12-MAY-00
HAYWARD, CA 94545-1134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALL-PRO 2010
ALL-PRO IMAGING CORP. 510(k) NO: K001321(TRADITIONAL)
ATTN: JOSEPH CAREY PHONE NO : 516-433-7676
70 CANTIAGUE ROCK RD. SE DECISION MADE: 16-MAY-00
HICKSVILLE, NY 11801 510(k) STATEMENT
DEVICE: POWDER FREE STERILE LATEX EXAMINATION GLOVES
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K001141(SPECIAL)
ATTN: ERICA SETHI PHONE NO : 847-785-3337
1500 WAUKEGAN RD. SE DECISION MADE: 09-MAY-00
BUILDING WM 510(k) SUMMARY AVAILABLE FROM FDA
MCGAW PARK, IL 60085
DEVICE: AMBU NEONATE SILICONE RESUSCITATOR
AMBU, INC. 510(k) NO: K993278(TRADITIONAL)
ATTN: SANJAY PARIKH PHONE NO : 410-636-1144
611 NORTH HAMMONDS FERRY RD. SE DECISION MADE: 17-MAY-00
LINTHICUM, MD 21090-1356 510(k) STATEMENT
DEVICE: HEADLAMP HL2000.
ANGIOLAZ, INC. 510(k) NO: K994362(TRADITIONAL)
ATTN: ROBERT ALLMAN PHONE NO : 802-463-9976
P.O.BOX 556 SE DECISION MADE: 11-MAY-00
BELLOWS FALLS, VT 05101 510(k) STATEMENT
DEVICE: ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LA
ANSELL PERRY INC. 510(k) NO: K001239(SPECIAL)
ATTN: JAMES R CHATTERTON PHONE NO : 330-833-2811
1875 HARSH AVENUE, S.E. SE DECISION MADE: 15-MAY-00
MASSILLON, OH 44646-7199 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENTRY EXPANDING INTRODUCER SHEATH (EIS)
APPLIED MEDICAL RESOURCES 510(k) NO: K000545(TRADITIONAL)
ATTN: ANIL BHALANI PHONE NO : 949-582-6120
26051 MERIT CIRCLE, #104 SE DECISION MADE: 02-MAY-00
LAGUNA HILLS, CA 92653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO
ARJO, INC. 510(k) NO: K001079(TRADITIONAL)
ATTN: DAVID INSCO PHONE NO : 630-307-6165
50 NORTH GARY AVE., SUITE A SE DECISION MADE: 01-MAY-00
ROSELLE, IL 60172-1684 510(k) STATEMENT
DEVICE: ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND
ARROW INTL., INC. 510(k) NO: K000729(SPECIAL)
ATTN: WILLIAM PAQUIN PHONE NO : 617-389-6400
9 PLYMOUTH ST. SE DECISION MADE: 19-MAY-00
EVERETT, MA 02149 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B
ARTHREX INCORPORATED 510(k) NO: K000506(TRADITIONAL)
ATTN: VERNON BROWN PHONE NO : 941-643-5553
2885 S. HORSESHOE DRIVE SE DECISION MADE: 01-MAY-00
NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENTEC REFLEX WAND 55, MODEL E4055-01, E4045-01
ARTHROCARE CORP. 510(k) NO: K000778(TRADITIONAL)
ATTN: BRUCE PROTHRO PHONE NO : 408-736-0224
595 NORTH PASTORIA AVE. SE DECISION MADE: 03-MAY-00
SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE,
ARTHROCARE CORP. 510(k) NO: K001302(TRADITIONAL)
ATTN: BRUCE PROTHRO PHONE NO : 408-736-0224
595 NORTH PASTORIA AVE. SE DECISION MADE: 30-MAY-00
SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUSTOMCORNEA MEASUREMENT DEVICE (CCMD)
AUTONOMOUS TECHNOLOGIES CORP. 510(k) NO: K000637(TRADITIONAL)
ATTN: S.K. MCGARVEY PHONE NO : 702-228-0880
2800 DISCOVERY DR. SE DECISION MADE: 19-MAY-00
ORLANDO, FL 32826 510(k) STATEMENT
DEVICE: AXIOM MULTIPURPOSE WOUND DRAIN
AXIOM MEDICAL, INC. 510(k) NO: K993592(TRADITIONAL)
ATTN: RIDWAN HARDY PHONE NO : 310-898-1779
555 WEST VICTORIA ST. SE DECISION MADE: 17-MAY-00
RANCHO DOMINGUEZ, CA 90220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARZELL-WHITMORE MAROON BELLS, INC. COLO-RECTAL MOVER, MODEL 390
BARZELL-WHITMORE MAROON BELLS, INC510(k) NO: K000960(TRADITIONAL)
ATTN: ART WARD PHONE NO : 813-645-2855
962 ALLEGRO LANE SE DECISION MADE: 26-MAY-00
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS
BAXTER EDWARDS 510(k) NO: K993816(TRADITIONAL)
ATTN: DIANE PETERSON PHONE NO : 949-250-3514
17221 RED HILL AVE. SE DECISION MADE: 04-MAY-00
IRVINE, CA 92614-5686 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM
BAYER CORP. 510(k) NO: K000903(TRADITIONAL)
ATTN: FREDRICK CLERIE PHONE NO : 914-524-2954
511 BENEDICT AVE. SE DECISION MADE: 18-MAY-00
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYER ADVIA IMS SYSTEM; 200 + 3
BAYER CORP. 510(k) NO: K000921(TRADITIONAL)
ATTN: FREDRICK CLERIE PHONE NO : 914-524-2954
511 BENEDICT AVE. SE DECISION MADE: 18-MAY-00
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIM
BD BIOSCIENCES 510(k) NO: K000611(TRADITIONAL)
ATTN: JO-ANN E FABILA PHONE NO : 408-954-2404
2350 QUME DRIVE SE DECISION MADE: 18-MAY-00
SAN JOSE, CA 95131-1807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE
BD BIOSCIENCES 510(k) NO: K000897(TRADITIONAL)
ATTN: CINDY MORROW PHONE NO : 408-954-2694
2350 QUME DRIVE SE DECISION MADE: 05-MAY-00
SAN JOSE, CA 95131-1807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY
BECKMAN COULTER, INC. 510(k) NO: K000121(TRADITIONAL)
ATTN: ANNETTE HELLIE PHONE NO : 714-933-8767
200 S. KRAEMER BOULEVARD SE DECISION MADE: 17-MAY-00
P.O. BOX 8000 510(k) SUMMARY AVAILABLE FROM FDA
BREA,, CA 92822-8000
DEVICE: SYNCHRON SYSTEMS AMPHETAMINE REAGENT
BECKMAN COULTER, INC. 510(k) NO: K000606(TRADITIONAL)
ATTN: LUCINDA STOCKERT PHONE NO : 714-961-3777
200 S. KRAEMER BLVD., W-104 SE DECISION MADE: 05-MAY-00
BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BELMONT UNIT, MODEL 2000 SERIES
BELMONT EQUIPMENT CORP. 510(k) NO: K000799(TRADITIONAL)
ATTN: JOHN E COLLINS PHONE NO : 732-469-5000
101 BELMONT DR. SE DECISION MADE: 17-MAY-00
SOMERSET, NJ 08873-1204 510(k) STATEMENT
DEVICE: RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR
BHK HOLDING 510(k) NO: K000108(TRADITIONAL)
ATTN: ART WARD PHONE NO : 813-645-2855
3234 ELLA LANE SE DECISION MADE: 23-MAY-00
NEW PORT RICHEY, FL 34655 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363
BIO-RAD LABORATORIES 510(k) NO: K001373(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285
9500 JERONIMO RD. SE DECISION MADE: 25-MAY-00
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210
BIOMERIEUX, INC. 510(k) NO: K993319(TRADITIONAL)
ATTN: ANNA DEMARINIS PHONE NO : 781-871-4442
1022 HINGHAM ST. SE DECISION MADE: 22-MAY-00
ROCKLAND, MA 02370 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REACH FEMORAL COMPONENT
BIOMET, INC. 510(k) NO: K000760(TRADITIONAL)
ATTN: MICHELLE L MCKINLEY PHONE NO : 219-372-1644
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 23-MAY-00
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46580
DEVICE: METAL ON METAL ACETABULAR SYSTEM
BIOMET, INC. 510(k) NO: K993438(TRADITIONAL)
ATTN: MICHELLE L MCKINLEY PHONE NO : 219-372-1644
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 18-MAY-00
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46580
DEVICE: MODIFICATION TO CARTO EP NAVIGATION SYSTEM
BIOSENSE WEBSTER, INC. 510(k) NO: K000190(SPECIAL)
ATTN: SIGI CARON PHONE NO : 800-729-9010
3333 DIAMOND CANYON RD. SE DECISION MADE: 05-MAY-00
DIAMOND BAR, CA 91765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARTO EP NAVIGATION SYSTEM
BIOSENSE WEBSTER, INC. 510(k) NO: K000248(SPECIAL)
ATTN: AMY WALTERS PHONE NO : 800-729-9010
3333 DIAMOND CANYON RD. SE DECISION MADE: 05-MAY-00
DIAMOND BAR, CA 91765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOGA CARDIAC NAVIGATION SYSTEM
BIOSENSE WEBSTER, INC. 510(k) NO: K000332(SPECIAL)
ATTN: AMY WALTERS PHONE NO : 800-729-9010
3333 DIAMOND CANYON RD. SE DECISION MADE: 04-MAY-00
DIAMOND BAR, CA 91765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2
BIOSENSE WEBSTER, INC. 510(k) NO: K001139(SPECIAL)
ATTN: MARY ADAMS PHONE NO : 909-839-8604
3333 DIAMOND CANYON RD. SE DECISION MADE: 10-MAY-00
DIAMOND BAR, CA 91765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AU5, AU6
BIOSOUND ESAOTE, INC. 510(k) NO: K000681(TRADITIONAL)
ATTN: COLLEEN HITTLE PHONE NO : 317-849-1793
8000 CASTLEWAY DR. SE DECISION MADE: 03-MAY-00
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSER
BIOSURGICAL CORP. 510(k) NO: K000438(TRADITIONAL)
ATTN: TERRY LAAS PHONE NO : 925-737-1850
5990 STONERIDGE AVE SE DECISION MADE: 03-MAY-00
SUITE 112 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANTON, CA 94588
DEVICE: ART-M1, MODEL M1-1-ART-A1
BONART CO. LTD. 510(k) NO: K000510(TRADITIONAL)
ATTN: BANKSON TSAI PHONE NO : 886 222 983980
RM. 405, NO.3 WUCHUAN 1ST ROAD SE DECISION MADE: 15-MAY-00
HSINCHUANG, TAIPEI, CHINA (TAIWAN)510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WALLSTENT ENTERNAL PROSTHESIS
BOSTON SCIENTIFIC CORP. 510(k) NO: K000281(TRADITIONAL)
ATTN: LISA M QUAGLIA PHONE NO : 508-650-8267
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 12-MAY-00
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WALLSTENT BILIARY ENDOPROSTHESIS
BOSTON SCIENTIFIC CORP. 510(k) NO: K000308(TRADITIONAL)
ATTN: LISA M QUAGLIA PHONE NO : 508-650-8267
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 19-MAY-00
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEGABELLO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
BOSTON SCIENTIFIC CORP. 510(k) NO: K992320(TRADITIONAL)
ATTN: RONALD W BENNETT PHONE NO : 612-694-5642
5905 NATHAN LANE SE DECISION MADE: 18-MAY-00
PLYMOUTH, MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY
BOSTON SCIENTIFIC, TARGET 510(k) NO: K001083(SPECIAL)
ATTN: JAMES LEATHLEY PHONE NO : 510-440-7836
47900 BAYSIDE PARKWAY SE DECISION MADE: 03-MAY-00
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C-IT
BREGAS AB 510(k) NO: K000520(TRADITIONAL)
ATTN: PAUL KRILL PHONE NO : 468 629 2754
ULVSUNDAVAGEN 178B SE DECISION MADE: 16-MAY-00
BROMMA, SWEDEN SE-16867 510(k) STATEMENT
DEVICE: MACROPRO GEL
BRENNEN MEDICAL, INC. 510(k) NO: K000518(TRADITIONAL)
ATTN: PHIL LAWIN PHONE NO : 651-429-7413
1290 HAMMOND RD. SE DECISION MADE: 01-MAY-00
ST. PAUL, MN 55110 510(k) STATEMENT
DEVICE: GLUCANPRO
BRENNEN MEDICAL, INC. 510(k) NO: K000519(TRADITIONAL)
ATTN: PHIL LAWIN PHONE NO : 651-429-7413
1290 HAMMOND RD. SE DECISION MADE: 01-MAY-00
ST. PAUL, MN 55110 510(k) STATEMENT
DEVICE: VISIONARY 2000
BURTON MEDICAL PRODUCTS CORP. 510(k) NO: K000639(TRADITIONAL)
ATTN: DORIAN SWARTZ PHONE NO : 818-701-8700
21100 LASSEN ST. SE DECISION MADE: 25-MAY-00
CHATSWORTH, CA 91311 510(k) STATEMENT
DEVICE: CANDELA GENTLELASE GL DERMATOLOGICAL LASER
CANDELA CORP. 510(k) NO: K994260(TRADITIONAL)
ATTN: JAY CAPLAN PHONE NO : 508-358-7400
530 BOSTON POST RD. SE DECISION MADE: 26-MAY-00
WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDTEL, MODEL NT-100
CARDIAC TELECOMMUNICATIONS 510(k) NO: K000609(TRADITIONAL)
ATTN: J. HARVEY KNAUSS PHONE NO : 713-723-8169
11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 23-MAY-00
HOUSTON, TX 77071-3404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT
CARDIODYNAMICS INTERNATIONAL CORP.510(k) NO: K001100(SPECIAL)
ATTN: BRIAN PARK PHONE NO : 858-535-0202
6175 NANCY RIDGE DR., #300 SE DECISION MADE: 05-MAY-00
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, IN
CARMEL PHARMA AB. 510(k) NO: K001368(SPECIAL)
ATTN: KJELL ANDREASSON PHONE NO : 463 170 30400
BOX 5352 SE DECISION MADE: 12-MAY-00
GOTEBORG, SWEDEN S-40228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TROJAN EXTRA LARGE LATEX CONDOM
CARTER-WALLACE, INC. 510(k) NO: K001212(SPECIAL)
ATTN: STEPHEN C KOLAKOWSKY PHONE NO : 609-655-6308
HALF ACRE RD. SE DECISION MADE: 09-MAY-00
P.O. BOX 1001 510(k) SUMMARY AVAILABLE FROM FDA
CRANBURY, NJ 08512
DEVICE: KROM-ALGINATE AND ALGINATE PLUS
CAVEX HOLLAND B.V. 510(k) NO: K000686(TRADITIONAL)
ATTN: RICHARD WOORTMAN PHONE NO : 011 312 35307763
PO BOX 852 SE DECISION MADE: 25-MAY-00
HAARLEM (HOLLAND), NETHERLANDS 200510(k) STATEMENT
DEVICE: PROVIEW MEDICAL IMAGE DISPLAY MODULE
CERNER CORP. 510(k) NO: K000770(TRADITIONAL)
ATTN: SHELLEY LOOBY PHONE NO : 816-201-1368
2800 ROCKCREEK PARKWAY SE DECISION MADE: 16-MAY-00
KANSAS CITY, MO 64117 510(k) STATEMENT
DEVICE: SOLO-CARE BRAND HARD SOLUTION
CIBA VISION CORP. 510(k) NO: K000607(TRADITIONAL)
ATTN: STEVEN DOWDLEY PHONE NO : 770-418-3897
11460 JOHNS CREEK PARKWAY SE DECISION MADE: 15-MAY-00
DULUTH, GA 30097-1556 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EYECAP IMAGING SYSTEM
CLEMENT CLARKE INTL., LTD. 510(k) NO: K000368(TRADITIONAL)
ATTN: M.J. WILKINSON PHONE NO : 440 127 9414969
EDINBURGH WAY SE DECISION MADE: 04-MAY-00
HARLOW, UNITED KINGDOM CM20 2TT 510(k) STATEMENT
DEVICE: COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN L
COMFORT RUBBER GLOVES INDUSTRIES S510(k) NO: K001042(TRADITIONAL)
ATTN: CHEE YONG FOO PHONE NO : 605 847 2777
LOT 821, JALAN MATANG SE DECISION MADE: 23-MAY-00
TAIPING, PERAK DARUL RIDZUAN, MALA510(k) STATEMENT
DEVICE: POLYMACON
COOPERVISION, INC. 510(k) NO: K001089(TRADITIONAL)
ATTN: BONNIE TSYMBAL PHONE NO : 716-264-3210
711 NORTH RD. SE DECISION MADE: 19-MAY-00
SCOTTSVILLE, NY 14546 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: METHAFILCON A
COOPERVISION, INC. 510(k) NO: K001090(TRADITIONAL)
ATTN: BONNIE TSYMBAL PHONE NO : 716-385-6810
711 NORTH RD. SE DECISION MADE: 19-MAY-00
SCOTTSVILLE, NY 14546 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEMPO AQUA ANGIOGRAPHIC CATHETER
CORDIS CORP. 510(k) NO: K000579(SPECIAL)
ATTN: ARIEL MACTAVISH PHONE NO : 305-824-2332
14201 N.W. 60TH AVE. SE DECISION MADE: 03-MAY-00
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DINAMAP ADVANCED NIBP MODULE
CRITIKON COMPANY, L.L.C. 510(k) NO: K000500(TRADITIONAL)
ATTN: THOMAS J ENGLISH PHONE NO : 813-887-2107
4502 WOODLAND CORPORATE BLVD SE DECISION MADE: 26-MAY-00
TAMPA, FL 33614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BEHRING COAGULATION SYSTEM (BCS)
DADE BEHRING, INC. 510(k) NO: K000973(TRADITIONAL)
ATTN: REBECCA S AYASH PHONE NO : 302-631-6276
GLASGOW SITE SE DECISION MADE: 26-MAY-00
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714
DEVICE: SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
DADE BEHRING, INC. 510(k) NO: K001145(TRADITIONAL)
ATTN: RADAMES RIESGO PHONE NO : 305-392-5639
7739 NW 48 STREET SE DECISION MADE: 11-MAY-00
SUITE 120 510(k) SUMMARY AVAILABLE FROM FDA
MIAMI, FL 33166
DEVICE: CONTROL PLASMA N
DADE BEHRING, INC. 510(k) NO: K001256(TRADITIONAL)
ATTN: DONNA A WOLF PHONE NO : 302-631-0384
PO BOX 6101 SE DECISION MADE: 24-MAY-00
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX
DAIG CORP. 510(k) NO: K994334(SPECIAL)
ATTN: TODD KORNMANN PHONE NO : 612-933-4700
14901 DEVEAU PL. SE DECISION MADE: 15-MAY-00
MINNETONKA, MN 55345-2126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINO
DATASCOPE CORP. 510(k) NO: K001198(SPECIAL)
ATTN: JOANN WOLF PHONE NO : 973-244-6123
15 LAW DR. SE DECISION MADE: 12-MAY-00
FAIRFIELD, NJ 07004-3206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR
DATEX-OHMEDA, INC. 510(k) NO: K000706(SPECIAL)
ATTN: DANIEL KOSEDNAR PHONE NO : 608-221-1551
OHMEDA DR. SE DECISION MADE: 11-MAY-00
MADISON, WI 53707 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C&B RESIN PLUS POWDER/LIQUID, MODELS RETEMP A2, A3, A3.5, CL, RE
DENTAL VENTURES OF AMERICA, INC. 510(k) NO: K000894(TRADITIONAL)
ATTN: ANTHONY SIRAGUSA PHONE NO : 909-270-0606
217 LEWIS CT. SE DECISION MADE: 19-MAY-00
CORONA, CA 91720 510(k) STATEMENT
DEVICE: ERS RADIAL HEAD REPLACEMENT
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K000658(TRADITIONAL)
ATTN: LYNNETTE WHITAKER PHONE NO : 219-371-4903
P.O. BOX 988 SE DECISION MADE: 11-MAY-00
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K001451(SPECIAL)
ATTN: JANET G JOHNSON PHONE NO : 219-371-4907
700 ORTHOPAEDIC DR. SE DECISION MADE: 18-MAY-00
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900
DIAGNOSTIC SYSTEMS LABORATORIES, I510(k) NO: K001086(TRADITIONAL)
ATTN: JOHN CLASS PHONE NO : 281-332-9679
445 MEDICAL CENTER BLVD. SE DECISION MADE: 18-MAY-00
WEBSTER, TX 77598 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A100 AESTHETIC DIODE LASER
DIOMED, INC. 510(k) NO: K000982(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 781-334-2522
1 WING ROAD SE DECISION MADE: 01-MAY-00
LYNNFIELD, MA 01940 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)
DMC MEDICAL LTD. 510(k) NO: K000704(TRADITIONAL)
ATTN: CHARMAINE HENDERSON PHONE NO : 714-525-8441
511 CATALINA ROAD SE DECISION MADE: 19-MAY-00
FULLERTON, CA 92835 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DORNIER MEDILAS H
DORNIER SURGICAL PRODUCTS, INC. 510(k) NO: K001243(TRADITIONAL)
ATTN: JOE D BROWN PHONE NO : 850-234-7153
8623 N. LAGOON DRIVE SE DECISION MADE: 24-MAY-00
SUITE C3 510(k) STATEMENT
PANAMA CYT BCH, FL
DEVICE: SYNTHETIC GLASS BONE GRAFT MATERIAL
DR. ALBERT ZICKMANN 510(k) NO: K000633(TRADITIONAL)
ATTN: RITA GIEBEL PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 25-MAY-00
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, MODE
DYMEDIX, INC. 510(k) NO: K001030(ABBREVIATED)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LANE SE DECISION MADE: 11-MAY-00
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHARPLAN LASERS, INC. PULSED CTH:YAG HOLMIUM SURGICAL LASER, MOD
E S C SHARPLAN 510(k) NO: K001263(SPECIAL)
ATTN: ZVI LADIN PHONE NO : 781-278-7600
100 MORSE ST. SE DECISION MADE: 05-MAY-00
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EAGLE ENDO SPECIMEN RETRIEVAL BAG
EAGLE ENDOSCOPIC, INC. 510(k) NO: K001264(TRADITIONAL)
ATTN: JOHN MAYALL PHONE NO : 940-464-6021
700 SEALS RD. SE DECISION MADE: 30-MAY-00
BARTONVILLE, TX 76226 510(k) STATEMENT
DEVICE: EBI XFIX DFS METAPHYSEAL CORRECTION SYSTEM
EBI, L.P. 510(k) NO: K001358(SPECIAL)
ATTN: PATRICIA FLOOD PHONE NO : 973-299-9022
100 INTERPACE PKWY. SE DECISION MADE: 23-MAY-00
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS
ELAN DIAGNOSTICS 510(k) NO: K000556(TRADITIONAL)
ATTN: WYNN STOCKING PHONE NO : 714-871-8360
231 NORTH PUENTE ST. SE DECISION MADE: 17-MAY-00
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS
ELAN HOLDINGS, INC. 510(k) NO: K000900(TRADITIONAL)
ATTN: WYNN STOCKING PHONE NO : 714-871-8360
231 NORTH PUENTE ST. SE DECISION MADE: 02-MAY-00
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS
ELAN HOLDINGS, INC. 510(k) NO: K000958(TRADITIONAL)
ATTN: WYNN STOKING PHONE NO : 714-871-8360
231 NORTH PUENTE ST. SE DECISION MADE: 24-MAY-00
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTIVE ELECTRODE MONITORING SYSTEM
ELECTROSCOPE, INC. 510(k) NO: K000480(TRADITIONAL)
ATTN: LYNNE ARONSON PHONE NO : 303-697-8198
PO BOX 219 SE DECISION MADE: 02-MAY-00
INDIAN HILLS, CO 80454 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EINSTEIN PROCESSING AND REVIEW WORKSTATION
ELGEMS, LTD. 510(k) NO: K000395(TRADITIONAL)
ATTN: DAN LAOR PHONE NO : 972 485 63666
P.O. BOX 170 SE DECISION MADE: 03-MAY-00
TIRAT HACARMEL, ISRAEL 30200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGITRON IEC II
ELLMAN INTL., INC. 510(k) NO: K001253(TRADITIONAL)
ATTN: FRANK LIN PHONE NO : 516-569-1482
1135 RAILROAD AVE., SE DECISION MADE: 26-MAY-00
ELLMAN BLDG. 510(k) SUMMARY AVAILABLE FROM FDA
HEWLETT, NY 11557
DEVICE: KEYSTONE HIP
ENCORE ORTHOPEDICS, INC. 510(k) NO: K000521(TRADITIONAL)
ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-834-6237
9800 METRIC BLVD. SE DECISION MADE: 10-MAY-00
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LATERAL PIVOT INSERT
ENCORE ORTHOPEDICS, INC. 510(k) NO: K000590(TRADITIONAL)
ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-834-6237
9800 METRIC BLVD. SE DECISION MADE: 11-MAY-00
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASS SPINAL SYSTEM
ENCORE ORTHOPEDICS, INC. 510(k) NO: K001024(TRADITIONAL)
ATTN: DE LOS SANTOS PHONE NO : 512-834-6237
9800 METRIC BLVD. SE DECISION MADE: 23-MAY-00
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEMSTOP CEMENT RESTRICTOR
ENCORE ORTHOPEDICS, INC. 510(k) NO: K993841(TRADITIONAL)
ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-834-6237
9800 METRIC BLVD. SE DECISION MADE: 04-MAY-00
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SWIVEL ELBOW
ENGINEERED MEDICAL SYSTEMS 510(k) NO: K000215(TRADITIONAL)
ATTN: BONNIE HOLLY PHONE NO : 317-246-5500
2055 EXECUTIVE DR. SE DECISION MADE: 26-MAY-00
INDIANAPOLIS, IN 46241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER
ENVIRONMENTAL TECTONICS CORP. 510(k) NO: K993010(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5600
555 THIRTEENTH STREET, N.W. SE DECISION MADE: 30-MAY-00
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOPATH SURESEAL REDUCER CAP
ETHICON ENDO-SURGERY, INC. 510(k) NO: K001220(TRADITIONAL)
ATTN: TAMIMA ITANI PHONE NO : 513-337-8205
4545 CREEK ROAD SE DECISION MADE: 16-MAY-00
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL
ETHICON, INC. 510(k) NO: K001122(TRADITIONAL)
ATTN: GREGORY R JONES PHONE NO : 908-218-2481
ROUTE 22 SE DECISION MADE: 23-MAY-00
SOMERVILLE, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
EVERGREEN MEDICAL PRODUTS (JINGXIN510(k) NO: K994098(TRADITIONAL)
ATTN: DOREEN FENG PHONE NO : 863 112 361035
THE NORTH OF BEISHIMEN VILLAGE SE DECISION MADE: 23-MAY-00
#1,EVERGREEN RD., XIAZUO TOWN 510(k) SUMMARY AVAILABLE FROM FDA
SHIJIAZHUANG CITY,HEBEI PROV., CHINA 050306
DEVICE: ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTED
EXACTECH, INC. 510(k) NO: K001335(SPECIAL)
ATTN: LISA SIMPSON PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 18-MAY-00
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-2
FISCHER IMAGING CORP. 510(k) NO: K991293(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 303-254-2521
12300 NORTH GRANT ST. SE DECISION MADE: 05-MAY-00
DENVER, CO 80241-3120 510(k) STATEMENT
DEVICE: POWDERFREE LATEX SURGEON'S GLOVES WITH PROTIEN LABELING CLAIM (5
FITCO DIPPED PRODUCTS PVT. LTD 510(k) NO: K000896(TRADITIONAL)
ATTN: JOSEPH J E PEREIRA PHONE NO : 914 844 21983
14-A COCHIN EXPORT PROCESSING SE DECISION MADE: 03-MAY-00
ZONE, KAKKANAND, KOCHI 510(k) STATEMENT
KERALA, INDIA 682 030
DEVICE: NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LA
FITCO DIPPED PRODUCTS PVT. LTD 510(k) NO: K001232(TRADITIONAL)
ATTN: JOSEPH J E PEREIRA PHONE NO : 91 484 421983
14-A COCHIN EXPORT PROCESSING SE DECISION MADE: 15-MAY-00
ZONE, KAKKANAND, COCHIN 510(k) STATEMENT
KERALA, INDIA 682 030
DEVICE: FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #0
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K000451(TRADITIONAL)
ATTN: ARTHUR EILINSFELD PHONE NO : 781-402-9068
95 HAYDEN AVE SE DECISION MADE: 09-MAY-00
LEXINGTON, MA 02173 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSI
GE MARQUETTE MEDICAL SYSTEMS, INC.510(k) NO: K000645(TRADITIONAL)
ATTN: IAN MCDONALD PHONE NO : 281-275-5109
13000 EXECUTIVE DR. SE DECISION MADE: 24-MAY-00
SUGAR LAND, TX 77478 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEXPRO TELEMETRY SYSTEM
GE MARQUETTE MEDICAL SYSTEMS, INC.510(k) NO: K000779(TRADITIONAL)
ATTN: DAVID WAHLIG PHONE NO : 414-362-2793
8200 WEST TOWER AVE. SE DECISION MADE: 18-MAY-00
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIRAL IMAGING OPTION
GE MEDICAL SYSTEMS 510(k) NO: K000802(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 414-544-3894
P.O. BOX 414, W-709 SE DECISION MADE: 26-MAY-00
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE SYSTEM FIVE
GE MEDICAL SYSTEMS, INC. 510(k) NO: K001267(SPECIAL)
ATTN: ALLEN SCHUH PHONE NO : 414-647-4385
P.O. BOX 414 SE DECISION MADE: 12-MAY-00
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEIGER NEEDLE ADAPTER, MODEL 406
GEIGER MEDICAL TECHNOLOGIES, INC. 510(k) NO: K001029(TRADITIONAL)
ATTN: JOHN BOTTJER PHONE NO : 949-240-7584
24040 CAMINO DEL AVION, A-195 SE DECISION MADE: 23-MAY-00
MONARCH BEACH, CA 92629 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GO MEDICAL BALLOON INFUSION SYSTEM
GO MEDICAL INDUSTRIES PTY. LTD. 510(k) NO: K000263(TRADITIONAL)
ATTN: GEORGE O'NEIL PHONE NO : 618 938 81991
200 CHURCHILL AVE. SE DECISION MADE: 09-MAY-00
SUBIACO, PERTH, AUSTRALIA 6008 510(k) STATEMENT
DEVICE: BVBLUE
GRYPHUS DIAGNOSTICS, L.L.C. 510(k) NO: K993732(TRADITIONAL)
ATTN: THOMAS M TSAKERIS PHONE NO : 301-330-2076
16809 BRIARDALE ROAD SE DECISION MADE: 15-MAY-00
ROCKVILLE, MD 20855 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 10055
GUIDANT CORP. 510(k) NO: K001222(SPECIAL)
ATTN: MARGARET ANDERSON PHONE NO : 408-845-3995
3200 LAKESIDE DR. SE DECISION MADE: 17-MAY-00
P.O. BOX 58167 510(k) SUMMARY AVAILABLE FROM FDA
SANTA CLARA, CA 95054-2807
DEVICE: RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129
GUIDANT CORP. 510(k) NO: K001224(SPECIAL)
ATTN: MARGARET ANDERSON PHONE NO : 408-845-3995
3200 LAKESIDE DR. SE DECISION MADE: 17-MAY-00
P.O. BOX 58167 510(k) SUMMARY AVAILABLE FROM FDA
SANTA CLARA, CA 95054-2807
DEVICE: GUTHRIE POWDER-FREE LATEX SURGICAL GLOVE WITH (50 MICROGRAMS OR
GUTHRIE MEDICARE PRODUCTS (NS) SDN510(k) NO: K001049(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 23-MAY-00
GREAT NECK, NY 11021 510(k) STATEMENT
DEVICE: THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES
HAEMOSCOPE CORP. 510(k) NO: K993678(TRADITIONAL)
ATTN: ELI COHEN PHONE NO : 847-329-0001
7855 GROSS POINT RD., UNIT G-4 SE DECISION MADE: 05-MAY-00
SKOKIE, IL 60077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOTOMASTER
HAMILTON THORNE RESEARCH 510(k) NO: K000380(TRADITIONAL)
ATTN: MEG D HAMILTON PHONE NO : 978-921-2050
100 CUMMINGS CENTER SE DECISION MADE: 03-MAY-00
SUITE 102-C 510(k) SUMMARY AVAILABLE FROM FDA
BEVERLY, MA 01915
DEVICE: POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING
HARTALEGA SDN BHD 510(k) NO: K993760(TRADITIONAL)
ATTN: KUAN KAM HON PHONE NO : 036 342 177
9 JALAN KUANG BULAN TAMAN SE DECISION MADE: 15-MAY-00
KEPONG INDUSTRIAL ESTATE 510(k) STATEMENT
KUALA LUMPUR, MALAYSIA 52100
DEVICE: HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP
HEALTHCARE SERVICE AND SUPPLY 510(k) NO: K000303(TRADITIONAL)
ATTN: RICK ROEDER PHONE NO : 714-669-8803
P.O. BOX 1788 SE DECISION MADE: 16-MAY-00
TUSTIN, CA 92681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23
HEARTPORT, INC. 510(k) NO: K994243(SPECIAL)
ATTN: MARIANNE C DRENNAN PHONE NO : 650-482-4405
700 BAY RD. SE DECISION MADE: 05-MAY-00
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, D
HEWLETT-PACKARD CO. 510(k) NO: K992543(TRADITIONAL)
ATTN: TERESA SKARR PHONE NO : 206-664-5290
2401 FOURTH AVE., SUITE 500 SE DECISION MADE: 18-MAY-00
SEATTLE, WA 98121-1436 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HM-930 ELECTROSURGICAL UNIT
HILL-MED, INC. 510(k) NO: K993991(TRADITIONAL)
ATTN: JHOANA VASQUEZ PHONE NO : 305-594-8574
7217 N.W. 46TH STREET SE DECISION MADE: 30-MAY-00
MIAMI, FL 33166 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM
HOPKINS IMAGING SYSTEMS, INC. 510(k) NO: K000630(TRADITIONAL)
ATTN: RICHARD HOPKINS PHONE NO : 626-305-8833
1812 FLOWER AVE. SE DECISION MADE: 12-MAY-00
DUARTE, CA 91010 510(k) STATEMENT
DEVICE: STRYKER TRAUMA PLATING SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K000636(TRADITIONAL)
ATTN: MARY-CATHERINE DILLON PHONE NO : 201-760-8117
59 ROUTE 17 SE DECISION MADE: 11-MAY-00
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOFFMANN II EXTERNAL FIXATION SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K000957(TRADITIONAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187
59 ROUTE 17 SE DECISION MADE: 23-MAY-00
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTI-AXIAL CROSS (MAC) CONNECTOR
HOWMEDICA OSTEONICS CORP. 510(k) NO: K000965(SPECIAL)
ATTN: TERRY SHERIDAN POWELL PHONE NO : 201-934-4375
59 ROUTE 17 SE DECISION MADE: 11-MAY-00
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XIA SPINE SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K001272(SPECIAL)
ATTN: MARY-CATHERINE DILLON PHONE NO : 201-760-8117
59 ROUTE 17 SE DECISION MADE: 11-MAY-00
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XIA SPINE SYSTEM HOOKS
HOWMEDICA OSTEONICS CORP. 510(k) NO: K001319(SPECIAL)
ATTN: MARY-CATHERINE DILLON PHONE NO : 201-760-8117
59 ROUTE 17 SE DECISION MADE: 23-MAY-00
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT
HUDSON RESPIRATORY CARE, INC. 510(k) NO: K993355(TRADITIONAL)
ATTN: CHARLES MIERKIEWICZ PHONE NO : 909-676-5611
27711 DIAZ RD. SE DECISION MADE: 24-MAY-00
TEMECULA, CA 92589-9020 510(k) STATEMENT
DEVICE: PASTEUR PIPET - STERILE 9", PASTEUR PIPET - STERILE 5 3/4", MODE
HUMAGEN FERTILITY DIAGNOSTICS, INC510(k) NO: K000915(TRADITIONAL)
ATTN: CINDY SHOWALTER PHONE NO : 804-979-4000
2400 HUNTER'S WAY SE DECISION MADE: 12-MAY-00
CHARLOTTESVILLE, VA 22911 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POSI-LINK
ICU MEDICAL, INC. 510(k) NO: K000472(TRADITIONAL)
ATTN: SALVADORE F PALOMARES PHONE NO : 949-366-2183
951 CALLE AMANECER SE DECISION MADE: 10-MAY-00
SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTI-PULSE 2000
IMAGING SCIENCES INTL., INC. 510(k) NO: K001248(TRADITIONAL)
ATTN: ROBERT E HAY PHONE NO : 215-997-5666
1910 NORTH PENN RD. SE DECISION MADE: 04-MAY-00
HATFIELD, PA 19440 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTINUUM KNEE SYSTEM-PS FEMORAL COMPONENTS- POROUS, MODEL XX-YY
IMPLEX CORP. 510(k) NO: K001307(SPECIAL)
ATTN: JOHN SCHALAGO PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 23-MAY-00
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS)
INNERDYNE, INC. 510(k) NO: K992668(TRADITIONAL)
ATTN: RICK GAYKOWSKI PHONE NO : 801-350-3600
5060 WEST AMELIA EARHART DR. SE DECISION MADE: 26-MAY-00
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYDRO2, HS-75
INNOVISION, INC. 510(k) NO: K000485(TRADITIONAL)
ATTN: DON M WOODFORD PHONE NO : 402-558-3000
3125 SOUTH 61ST AVE. SE DECISION MADE: 12-MAY-00
OMAHA, NE 68106-3675 510(k) STATEMENT
DEVICE: DELTA 16 TACT
INSTRUMENTARIUM IMAGING, INC. 510(k) NO: K001171(TRADITIONAL)
ATTN: MAX LINDERT PHONE NO : 414-747-1030
300 WEST EDGERTON AVE. SE DECISION MADE: 12-MAY-00
MILWAUKEE, WI 53207-6025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERCURE LTD. RESPI-LOW
INTERCURE LTD. 510(k) NO: K000405(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 13TH STREET N.W. SE DECISION MADE: 17-MAY-00
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRACOIL STENT
INTRATHERAPEUTICS, INC. 510(k) NO: K001257(SPECIAL)
ATTN: MARIA E BRITTLE PHONE NO : 651-697-2018
651 CAMPUS DR. SE DECISION MADE: 18-MAY-00
ST. PAUL, MN 55112-3495 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B
INVASATEC 510(k) NO: K984231(TRADITIONAL)
ATTN: KATE ANDERSON PHONE NO : 612-941-3507
7450 FLYING CLOUD DRIVE SE DECISION MADE: 31-MAY-00
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
EDEN PRAIRIE, MN 55344
DEVICE: IVC TWO MEDIUM
INVITROCARE, INC. 510(k) NO: K000937(TRADITIONAL)
ATTN: ROBERT E LOVINS PHONE NO : 858-452-1986
11408 SORRENTO VALLEY RD. SE DECISION MADE: 25-MAY-00
SUITE 202 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92121
DEVICE: IVC ONE MEDIUM
INVITROCARE, INC. 510(k) NO: K000938(TRADITIONAL)
ATTN: ROBERT E LOVINS PHONE NO : 858-452-1986
11408 SORRENTO VALLEY RD. SE DECISION MADE: 25-MAY-00
SUITE 202 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92121
DEVICE: HTF-HEPES
INVITROCARE, INC. 510(k) NO: K000939(TRADITIONAL)
ATTN: ROBERT E LOVINS PHONE NO : 858-452-1986
11408 SORRENTO VALLEY RD. SE DECISION MADE: 04-MAY-00
SUITE 202 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92121
DEVICE: HUMAN SERUM ALBUMIN (HSA)
INVITROCARE, INC. 510(k) NO: K000940(TRADITIONAL)
ATTN: ROBERT E LOVINS PHONE NO : 858-452-1986
11408 SORRENTO VALLEY RD. SE DECISION MADE: 04-MAY-00
SUITE 202 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92121
DEVICE: Q-HTF, CAT# 2001
INVITROCARE, INC. 510(k) NO: K993484(TRADITIONAL)
ATTN: ROBERT E LOVINS PHONE NO : 858-452-1986
11408 SORRENTO VALLEY RD. SE DECISION MADE: 25-MAY-00
SUITE 202 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92121
DEVICE: SIMPLEX AIRBRATOR (SAB-7)
IRT MANAGEMENT CORP. 510(k) NO: K980672(TRADITIONAL)
ATTN: NICHOLAS G LEVANDOSKI, PH.D.PHONE NO : 954-455-0110
470 ANSIN BLVD., SUITE G SE DECISION MADE: 04-MAY-00
HALLANDALE, FL 33009 510(k) STATEMENT
DEVICE: SHUTTLE STOP
ISOTIS BV 510(k) NO: K000587(TRADITIONAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 919-859-4207
49 PLAIN STREET SE DECISION MADE: 04-MAY-00
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JETLITE 4000
J. MORITA USA, INC. 510(k) NO: K000078(TRADITIONAL)
ATTN: KEITH A BARRITT PHONE NO : 202-783-5070
601 13TH STREET, N.W. SE DECISION MADE: 15-MAY-00
SUITE 500 NORTH 510(k) STATEMENT
WASHINGTON, DC 20005
DEVICE: JEL BIOS 90 (CODE NAME RD-2401)
J.F. JELENKO & CO., INC. 510(k) NO: K001196(TRADITIONAL)
ATTN: RAPHAEL JUDKINS PHONE NO : 914-273-8600
99 BUSINESS PARK DR. SE DECISION MADE: 11-MAY-00
ARMONK, NY 10504 510(k) STATEMENT
DEVICE: ALLROUND 55 LF
J.F. JELENKO & CO., INC. 510(k) NO: K001260(TRADITIONAL)
ATTN: RAPHAEL JUDKINS PHONE NO : 914-273-8600
99 BUSINESS PARK DR. SE DECISION MADE: 17-MAY-00
ARMONK, NY 10504 510(k) STATEMENT
DEVICE: WHEELCHAIR, MODELS H001A, 4422
JACKSON COMPANY LLC 510(k) NO: K000738(TRADITIONAL)
ATTN: DEBORAH WEIMAN PHONE NO : 410-850-0020
AIR CARGO COMPLEX BLDG. F SE DECISION MADE: 26-MAY-00
AIR CARGO DRIVE SUITE 2100 510(k) STATEMENT
BALTIMORE, MD 21240
DEVICE: KAVO K.E.Y. LASER 1242
KAVO AMERICA 510(k) NO: K000805(TRADITIONAL)
ATTN: JOHN FRANZ PHONE NO : 847-550-6800
340 EAST MAIN STREET SE DECISION MADE: 04-MAY-00
LAKE ZURICH, IL 60047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KAWASUMI LABORATORY BLOOD DRAWING KIT
KAWASUMI LABORATORIES AMERICA, INC510(k) NO: K001043(TRADITIONAL)
ATTN: JACK PAVLO PHONE NO : 813-630-5554
5905 C HAMPTON OAKS PKWY. SE DECISION MADE: 19-MAY-00
TAMPA, FL 33610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1
KEYMED (MEDICAL & INDUSTRIAL EQUIP510(k) NO: K000948(TRADITIONAL)
ATTN: ROGER GRAY PHONE NO : 441 702 616333
STOCK RD. SE DECISION MADE: 12-MAY-00
SOUTHEND-ON-SEA, ESSEX, UNITED KIN510(k) STATEMENT
DEVICE: HME-BOOSTER
KING SYSTEMS CORP. 510(k) NO: K990614(TRADITIONAL)
ATTN: CHARLES A BURT PHONE NO : 317-776-6823
15011 HERRIMAN BLVD. SE DECISION MADE: 23-MAY-00
P.O. BOX 1138 510(k) STATEMENT
NOBLESVILLE, IN 46060
DEVICE: POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50
KOSSAN LATEX INDUSTRIES (M) SDN. B510(k) NO: K001190(TRADITIONAL)
ATTN: LIM KWAN HWA PHONE NO : 603 392 7616
LOT 16632, 5-1/4 MILES, SE DECISION MADE: 23-MAY-00
JALAN MERU 510(k) STATEMENT
KELANG, SELANGOR, MALAYSIA 41050
DEVICE: SONOS AIRES 600 (SA-600)
KPI ULTRASOUND, LLC 510(k) NO: K000320(TRADITIONAL)
ATTN: STEVEN S MINN PHONE NO : 310-900-0690
18626 S. WILMINGTON AVE. SE DECISION MADE: 02-MAY-00
# 100 510(k) SUMMARY AVAILABLE FROM FDA
RANCHO DOMINGEUS, CA 90220
DEVICE: KRONNER LOW PROFILE SCOPE HOLDER
KRONNER PROTOTYPES, INC. 510(k) NO: K000663(TRADITIONAL)
ATTN: RICHARD KRONNER PHONE NO : 541-672-2543
1443 UPPER CLEVELAND RAPIDS RD SE DECISION MADE: 02-MAY-00
ROSEBURG, OR 97470 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201
LABOTECT LABOR-TECHNIK GOTTINGEN 510(k) NO: K000950(TRADITIONAL)
ATTN: ANGELIKA ALBRECHT PHONE NO : 055 150 5010
WILLI-EICHLER-STR. 25 SE DECISION MADE: 12-MAY-00
GOTTINGEN, GERMANY D-37079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS
LASERSIGHT TECHNOLOGIES, INC. 510(k) NO: K001144(TRADITIONAL)
ATTN: SAM MIRZA PHONE NO : 407-678-9900
3300 UNIVERSITY BLVD., #140 SE DECISION MADE: 05-MAY-00
WINTER PARK, FL 32792 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTIMUM WETTING AND REWETTING DROP
LOBOB LABORATORIES, INC. 510(k) NO: K001428(SPECIAL)
ATTN: DANIEL J MANELLI PHONE NO : 202-261-1040
2000 M STREET (#700) SE DECISION MADE: 26-MAY-00
WASHINGTON, DC 20036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRA CATHETER SET
LYCO ENT., INC. 510(k) NO: K001115(TRADITIONAL)
ATTN: ROBERT L CHILD PHONE NO : 915-833-3377
4727 OSBORNE DR., SE DECISION MADE: 17-MAY-00
BLDG. A, SUITE 100 510(k) STATEMENT
EL PASO, TX 79922-1011
DEVICE: MEDART 520 COOLING SYSTEM
MEDART CORP. 510(k) NO: K000503(TRADITIONAL)
ATTN: JAN K ENEMAERKE PHONE NO : 858-350-6066
11772 SORRENTO VALLEY RD. SE DECISION MADE: 15-MAY-00
SUITE 240 510(k) STATEMENT
SAN DIEGO, CA 92121
DEVICE: UNI-LASER 430
MEDART CORP. 510(k) NO: K993815(TRADITIONAL)
ATTN: JAN K ENEMAERKE PHONE NO : 858-350-6066
11772 SORRENTO VALLEY RD. SE DECISION MADE: 11-MAY-00
SUITE 240 510(k) STATEMENT
SAN DIEGO, CA 92121
DEVICE: MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP
MEDEX, INC. 510(k) NO: K000328(TRADITIONAL)
ATTN: CATHY CHENETSKI PHONE NO : 614-791-5412
6250 SHIER-RINGS RD. SE DECISION MADE: 09-MAY-00
DUBLIN, OH 43016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDI-CULT FLUSHING MEDIUM
MEDI-CULT A/S 510(k) NO: K991327(TRADITIONAL)
ATTN: RONALD G LEONARDI PHONE NO : 619-586-0751
9915 CAM. CHIRIMOLLA SE DECISION MADE: 04-MAY-00
SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDI-CULT SPERM PREPARATION - MEDIUM;
MEDI-CULT A/S 510(k) NO: K991332(TRADITIONAL)
ATTN: RONALD G LEONARDI PHONE NO : 619-586-0751
9915 CAM. CHIRIMOLLA SE DECISION MADE: 04-MAY-00
SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDI-CULT BLASTOCYST FREEZING & THAWING PACKS, INTERNAL CATALOG
MEDI-CULT A/S 510(k) NO: K991471(TRADITIONAL)
ATTN: RONALD G LEONARDI PHONE NO : 619-586-0751
P.O. BOX 262069 SE DECISION MADE: 09-MAY-00
SAN DIEGO, CA 92196-2069 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDI-CULT EMBRYO FREEZING MEDIUM INTERNAL CATAGLOG NUMBERS 1079
MEDI-CULT A/S 510(k) NO: K991472(TRADITIONAL)
ATTN: RONALD G LEONARDI PHONE NO : 619-586-0751
9915 CAM. CHIRIMOLLA SE DECISION MADE: 09-MAY-00
SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER
MEDICA CORP. 510(k) NO: K000926(TRADITIONAL)
ATTN: PHOTIOS MAKRIS PHONE NO : 781-275-4892
14 DEANGELO DR. SE DECISION MADE: 15-MAY-00
BEDFORD, MA 01730 510(k) STATEMENT
DEVICE: PROAIR 3000 COMPRESSION SYSTEM
MEDICAL COMPRESSION SYSTEMS (D.B.N510(k) NO: K993758(TRADITIONAL)
ATTN: SHOSHANA FRIEDMAN PHONE NO : 972 977 18130
117 AHUZAH ST. SE DECISION MADE: 19-MAY-00
RA'ANANNA, ISRAEL 43373 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UMECO OPTIMA MULTILINE LASER SYSTEM
MEDICAL LASER SOLUTIONS LLC 510(k) NO: K000693(TRADITIONAL)
ATTN: IAIN D MILLER PHONE NO : 617-242-2218
36 MYSTIC STREET SE DECISION MADE: 16-MAY-00
CHARLESTOWN, MA 02129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLD
MEDIMOP MEDICAL PROJECTS, LTD. 510(k) NO: K001293(SPECIAL)
ATTN: BRUCE F MACKLER PHONE NO : 202-263-8900
815 CONNECTION AVENUE, N.W. SE DECISION MADE: 05-MAY-00
WASHINGTON, DC 20006-4004 510(k) STATEMENT
DEVICE: MEDIVISION I-VIEW PERSONAL VIDEO DISPLAY
MEDIVISION ENDOSCOPY 510(k) NO: K000669(TRADITIONAL)
ATTN: WAYNE B STERNER PHONE NO : 714-563-2772
1440 S. STATE COLLEGE BLDV. SE DECISION MADE: 26-MAY-00
#1D 510(k) STATEMENT
ANAHEIM, CA 92806
DEVICE: POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0
MEDTRONIC FUNCTIONAL DIAGNOSTICS A510(k) NO: K000386(TRADITIONAL)
ATTN: TOVE KJAER PHONE NO : 45 445 79000
16-18 TONSBAKKEN SE DECISION MADE: 05-MAY-00
SKOVLUNDE, DENMARK DK-2740 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORM
MEDTRONIC SURGICAL NAVIGATION 510(k) NO: K001153(SPECIAL)
ATTN: VICTORIA RENDON PHONE NO : 303-439-9709
530 COMPTON ST. SE DECISION MADE: 03-MAY-00
BROOMFIELD, CO 80020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MENICON SF-P
MENICON CO. LTD. 510(k) NO: K000233(TRADITIONAL)
ATTN: BEVERLEY D VENUTI PHONE NO : 978-658-6888
269A BALLARDVALE STREET SE DECISION MADE: 19-MAY-00
WILMINGTON, MA 01887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MENICON Z
MENICON U.S.A., INC. 510(k) NO: K000133(TRADITIONAL)
ATTN: BEVERLY D VENUTI PHONE NO : 978-658-6888
269 A BALLARDVALE STREET SE DECISION MADE: 19-MAY-00
WILMINGTON, MA 01887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ENVOY PATIENT MONITOR
MENNEN MEDICAL LTD. 510(k) NO: K000563(SPECIAL)
ATTN: KENNETH RAICHMAN PHONE NO : 972 983 83030
KIRYAT WEIZMANN SCIENCE PARK SE DECISION MADE: 17-MAY-00
P.O. BOX 102 510(k) SUMMARY AVAILABLE FROM FDA
REHOVOT, ISRAEL 76100
DEVICE: EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 1
MICRO THERAPEUTICS, INC. 510(k) NO: K001237(SPECIAL)
ATTN: TOM DAUGHTERS PHONE NO : 949-837-3700
2 GOODYEAR SE DECISION MADE: 18-MAY-00
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEDIA DAU AMPHASSURE ASSAY
MICROGENICS CORP. 510(k) NO: K994380(TRADITIONAL)
ATTN: NEAL BELLET PHONE NO : 510-979-5029
46360 FREMONT BLVD. SE DECISION MADE: 02-MAY-00
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE STRIPPER
MID-ATLANTIC DIAGNOSTICS, INC. 510(k) NO: K993699(TRADITIONAL)
ATTN: TERRANCE J FORTINO PHONE NO : 609-953-3380
338 STOKES RD. SE DECISION MADE: 16-MAY-00
MEDFORD, NJ 08055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISION ESTHETIC PORCELAIN SYSTEM
MIDATLANTIC DIVISION OF DENTREX, I510(k) NO: K000680(TRADITIONAL)
ATTN: LAURANCE W POWELL PHONE NO : 800-257-5782
600 DEER ROAD SE DECISION MADE: 25-MAY-00
SUITE 3 510(k) STATEMENT
CHERRY HILL, NJ 08034
DEVICE: 3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHE
MINNESOTA MINING AND MFG. CO. 510(k) NO: K000690(TRADITIONAL)
ATTN: LINDA JOHNSON PHONE NO : 651-737-4376
3M CENTER, BUILDING 275-5W-06 SE DECISION MADE: 17-MAY-00
ST. PAUL, MN 55144-1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTISAFE POWDER-FREE PATIENT LATEX EXAMINATION GLOVES WITH PROT
MULTISAFE SDN BHD 510(k) NO: K000999(TRADITIONAL)
ATTN: ABD. HADI BIN HUSIN PHONE NO : 605 434 8269
LOT 764 SE DECISION MADE: 22-MAY-00
BIDOR INDUSTRIAL ESTATE 510(k) STATEMENT
35500 BIDOR, PERAK, MALAYSIA 35500
DEVICE: BALLOON FOR ULTRASONIC ENDOSCOPES
N.M. BEALE CO. 510(k) NO: K992178(TRADITIONAL)
ATTN: NATHANIEL M BEALE PHONE NO : 978-456-9181
89 OLD SHIRLEY RD. SE DECISION MADE: 12-MAY-00
HARVARD, MA 01451 510(k) STATEMENT
DEVICE: NATURE'S CHEMIST PAIN RELIEF OINTMENT AND THERAPEUTIC ULTRASOUND
NATUROPATHIC LABORATORIES INTERNAT510(k) NO: K000604(TRADITIONAL)
ATTN: EMALEE G MURPHY PHONE NO : 202-496-7255
1900 K STREET, N.W. SE DECISION MADE: 23-MAY-00
WASHINGTON, DC 20006-1108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NDD MEDICAL TECHNOLOGIES EASYONE SPIROMETER: FRONTLINE MODEL 200
NDD MEDICAL TECHNOLOGIES 510(k) NO: K993921(TRADITIONAL)
ATTN: OSCAR KAELIN PHONE NO : 978-244-0620
17 PROGRESS ANENUE SE DECISION MADE: 23-MAY-00
CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NELSON WATER SYSTEMS FOR HEMODIALYSIS
NELSON ENVIRONMENTAL TECHNOLOGIES,510(k) NO: K993877(TRADITIONAL)
ATTN: BURKE A WEST PHONE NO : 956-618-0375
301-E N. MCCOLL RD. SE DECISION MADE: 25-MAY-00
MCALLEN, TX 78501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND
NEUROSOFT, INC. 510(k) NO: K000812(TRADITIONAL)
ATTN: DAVID B JONES PHONE NO : 915-845-5600
5700 CROMO DRIVE SE DECISION MADE: 17-MAY-00
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
EL PASO, TX 79912
DEVICE: NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240
NICHOLS INSTITUTE DIAGNOSTICS 510(k) NO: K994140(TRADITIONAL)
ATTN: JIMMY WONG PHONE NO : 949-240-5260
33051 CALLE AVIADOR SE DECISION MADE: 09-MAY-00
SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500
NONIN MEDICAL, INC. 510(k) NO: K001085(SPECIAL)
ATTN: RICHARD P BENNETT PHONE NO : 612-553-9968
2605 FERNBROOK LANE, NORTH SE DECISION MADE: 01-MAY-00
MINNEAPOLIS, MN 55447-4755 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APOLLO MULTI-RACIAL REFERENCE POPULATION
NORLAND MEDICAL SYSTEMS, INC. 510(k) NO: K993337(TRADITIONAL)
ATTN: TERRY SCHWALENBERG PHONE NO : 920-563-8456
W-6340 HACKBARTH RD. SE DECISION MADE: 16-MAY-00
FORT ATKINSON, WI 53538-8999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MD 10, SEM, SM 12, CBM
NOUVAG AG 510(k) NO: K000710(TRADITIONAL)
ATTN: MARGIT ESCHBAUMER PHONE NO : 498 341 915050
SUDETENSTRASSE 5 SE DECISION MADE: 11-MAY-00
KAUFBEUREN, GERMANY D-87600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY
NYCOMED AMERSHAM 510(k) NO: K993131(TRADITIONAL)
ATTN: JIMMIE K NOFFSINGER PHONE NO : 816-523-7491
P.O. BOX 22599 SE DECISION MADE: 22-MAY-00
KANSAS CITY, MO 64113 510(k) STATEMENT
DEVICE: MRI FASTSYSTEM RETRACTOR SYSTEM
OMNI-TRACT SURGICAL, DIV. MINN. SC510(k) NO: K001339(SPECIAL)
ATTN: CATHERINE MILLER PHONE NO : 612-623-0396
1100 NEW BRIGHTON BLVD. SE DECISION MADE: 17-MAY-00
MINNEAPOLIS, MN 55413-1660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTIVU HDVD SYSTEM
OPTIMIZE, INC. 510(k) NO: K001169(TRADITIONAL)
ATTN: KEN GONG PHONE NO : 408-358-0925
420 BLOSSOM HILL RD. SE DECISION MADE: 16-MAY-00
LOS GATOS, CA 95032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VU
ORATEC INTERVENTIONS, INC. 510(k) NO: K000691(TRADITIONAL)
ATTN: JENNIFER BRENNAN PHONE NO : 650-369-9904
3700 HAVEN COURT SE DECISION MADE: 04-MAY-00
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMI
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K001266(SPECIAL)
ATTN: DARLENE PHILLIPS PHONE NO : 716-453-4253
100 INDIGO CREEK DRIVE SE DECISION MADE: 02-MAY-00
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCT
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K001310(SPECIAL)
ATTN: MARLENE A SHULMAN PHONE NO : 716-453-4041
100 INDIGO CREEK DR. SE DECISION MADE: 05-MAY-00
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
OXOID, LTD. 510(k) NO: K000928(TRADITIONAL)
ATTN: ANDY HOLLINGSWORTH PHONE NO : 441 256 841144
WADE ROAD SE DECISION MADE: 15-MAY-00
BASINGSTOKE,HANTS, UNITED KINGDOM 510(k) STATEMENT
DEVICE: GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
OXOID, LTD. 510(k) NO: K000930(TRADITIONAL)
ATTN: ANDY HOLLINGSWORTH PHONE NO : 441 256 841144
WADE ROAD SE DECISION MADE: 22-MAY-00
BASINGSTOKE,HANTS, UNITED KINGDOM 510(k) STATEMENT
DEVICE: PALOMAR SLP 2000
PALOMAR MEDICAL TECHNOLOGIES, INC.510(k) NO: K994225(TRADITIONAL)
ATTN: MARCY MOORE PHONE NO : 919-363-2432
131 KELEKENT LANE SE DECISION MADE: 18-MAY-00
CARY, NC 27511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPORTSIGHT GP
PARAGON VISION SCIENCES 510(k) NO: K993586(TRADITIONAL)
ATTN: WILLIAM E MEYERS PHONE NO : 480-892-7602
947 EAST IMPALA AVE. SE DECISION MADE: 22-MAY-00
MESA, AZ 85204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF)
PECTOFIX, INC. 510(k) NO: K000694(TRADITIONAL)
ATTN: ERIC BANNON PHONE NO : 732-548-4459
481 MEMORIAL PARKWAY SE DECISION MADE: 11-MAY-00
METUCHEN, NJ 08840 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICKSCREEN PRO DRUG CUP, MODEL 9195X
PHAMATECH 510(k) NO: K001397(SPECIAL)
ATTN: CARL MONGIOVI PHONE NO : 858-635-5840
9265 ACTIVITY RD., #112-113 SE DECISION MADE: 26-MAY-00
SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS CT SECURA MV
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K000819(TRADITIONAL)
ATTN: FRANK GIANELLI PHONE NO : 203-926-7729
710 BRIDGEPORT AVE. SE DECISION MADE: 12-MAY-00
SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RUMBAR DRAINAGE SYSTEM
PHOENIX BIOMEDICAL CORP. 510(k) NO: K000514(TRADITIONAL)
ATTN: COURTNEY SMITH PHONE NO : 610-539-9300
2495 GENERAL ARMSTEAD AVE. SE DECISION MADE: 10-MAY-00
P.O. BOX 80390 510(k) STATEMENT
VALLEY FORGE, PA 19484
DEVICE: MODEL 4300 PSARRAY EEG ELECTRODE SET
PHYSIOMETRIX, INC. 510(k) NO: K001055(TRADITIONAL)
ATTN: DAWN E FRAZER PHONE NO : 978-670-2422
FIVE BILLERICA PARK, SE DECISION MADE: 11-MAY-00
101 BILLERICA AVE. 510(k) SUMMARY AVAILABLE FROM FDA
NORTH BILLERICA, MA 01862
DEVICE: PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601
PIONEER LABORATORIES, INC. 510(k) NO: K000734(TRADITIONAL)
ATTN: AMY MOMMAERTS PHONE NO : 906-226-9909
375 RIVER PARK CIRCLE SE DECISION MADE: 05-MAY-00
MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMAX 2
PLANMECA OY 510(k) NO: K000771(TRADITIONAL)
ATTN: BOB PIENKOWSKI PHONE NO : 630-953-2368
1250 GREENBRIAR SE DECISION MADE: 03-MAY-00
SUITE A 510(k) STATEMENT
ADDISON, IL 60111
DEVICE: MALE LATEX COMDOM WITH DOTTED SURFACE
PLEASURE LATEX PRODUCTS SDN. BHD. 510(k) NO: K001221(ABBREVIATED)
ATTN: KOI-YONG LIM PHONE NO : 603 874 0784
LOT 1365, 17TH MILES, JALAN SE DECISION MADE: 19-MAY-00
SUNGAI SEMBILANG 510(k) STATEMENT
JERAM, SELANGOR, MALAYSIA 45800
DEVICE: MODULAR-PLUS REVISION STEM
PLUS ORTHOPEDICS 510(k) NO: K994126(TRADITIONAL)
ATTN: HARTMUT LOCH PHONE NO : 619-455-2400
3550 GENERAL ATOMICS CT. SE DECISION MADE: 04-MAY-00
SAN DIEGO, CA 92121-1194 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RIGID GAS PERMEABLE CONTACT LENS
POLYMER TECHNOLOGY 510(k) NO: K000795(TRADITIONAL)
ATTN: DEBRA L.B. KETCHUM PHONE NO : 716-338-8638
1400 N GOODMAN STREET SE DECISION MADE: 26-MAY-00
P.O. BOX 450 510(k) SUMMARY AVAILABLE FROM FDA
ROCHESTER, NY 14603-0450
DEVICE: BIOSCANNER TRIGLYCERIDES TEST STRIPS
POLYMER TECHNOLOGY SYSTEMS, INC. 510(k) NO: K991894(TRADITIONAL)
ATTN: MARGO ENRIGHT PHONE NO : 317-870-5610
7736 ZIONSVILLE RD. SE DECISION MADE: 24-MAY-00
INDIANAPOLIS, IN 46268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR L
PREMIER PATHWAY SDN. BHD. 510(k) NO: K001327(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 23-MAY-00
SPARKS, NV 89430-9550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL
PRIME DENTAL MANUFACTURING, INC. 510(k) NO: K001108(TRADITIONAL)
ATTN: ROLANDDO MARASIGAN PHONE NO : 773-539-5927
3735 WEST BELMONT AVE. SE DECISION MADE: 30-MAY-00
CHICAGO, IL 60618 510(k) STATEMENT
DEVICE: ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID
PRINCETON BIOMEDITECH CORP. 510(k) NO: K001225(SPECIAL)
ATTN: JEMO KANG PHONE NO : 800-726-2670
4242 U.S. RT. 1 SE DECISION MADE: 17-MAY-00
MONMOUTH JUNCTION, NJ 08852-1905 510(k) STATEMENT
DEVICE: PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01
PRO. DUCT HEALTH, INC. 510(k) NO: K001098(TRADITIONAL)
ATTN: ANGELA B SOITO PHONE NO : 650-566-2330
1360 WILLOW ROAD, SUITE 201 SE DECISION MADE: 18-MAY-00
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONE BIOPSY NEEDLE
PROMEX, INC. 510(k) NO: K001132(TRADITIONAL)
ATTN: JOSEPH L MARK PHONE NO : 317-736-0128
3049 HUDSON STREET SE DECISION MADE: 01-MAY-00
FRANKLIN, IN 46131 510(k) STATEMENT
DEVICE: PSK ENDOSCOPE CLEANING SYSTEM
PSK CONNECTORS PTY LTD 510(k) NO: K000216(TRADITIONAL)
ATTN: BRIAN NEWTON PHONE NO : 336-992-3686
311 SOUTH MAIN STREET SE DECISION MADE: 09-MAY-00
KERNERSVILLE, NC 27284 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEI
PT. WRP BUANA MULTICORPORA 510(k) NO: K994426(TRADITIONAL)
ATTN: NG POY SIN PHONE NO : 061 642 461 642462
JALAN JERMAL NO. 20 SE DECISION MADE: 23-MAY-00
KELURAHAN SEI MATI 510(k) SUMMARY AVAILABLE FROM FDA
MEDAN-LABUHAN, INDONESIA
DEVICE: PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE
PULSION MEDICAL SYSTEMS, INC. 510(k) NO: K991886(TRADITIONAL)
ATTN: ULF BORG PHONE NO : 910-452-7386
8911 SEDGLEY DR. SE DECISION MADE: 11-MAY-00
WILMINGTON, NC 28412 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADC
QUEST MEDICAL, INC. 510(k) NO: K994274(TRADITIONAL)
ATTN: MALCOLM LEWIS PHONE NO : 800-627-0226
ONE ALLENTOWN PKWY. SE DECISION MADE: 31-MAY-00
ALLEN, TX 75002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES
R-GROUP INTL. 510(k) NO: K993777(TRADITIONAL)
ATTN: KERRY A KAHN PHONE NO : 352-378-3633
2321 N.W. 66TH CT., SUITE W-4 SE DECISION MADE: 25-MAY-00
GAINESVILLE, FL 32653 510(k) STATEMENT
DEVICE: MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
RADIONICS, INC. 510(k) NO: K001431(SPECIAL)
ATTN: KEVIN J O'CONNELL PHONE NO : 800-466-6814
22 TERRY AVE. SE DECISION MADE: 17-MAY-00
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIRECT TIBC KIT
REFERENCE DIAGNOSTICS, INC. 510(k) NO: K000781(TRADITIONAL)
ATTN: JOSEPH LAWLOR PHONE NO : 781-276-9000
23 CROSBY DR. SE DECISION MADE: 02-MAY-00
BEDFORD, MA 01730-1401 510(k) STATEMENT
DEVICE: DIRECT TIBC CALIBRATOR
REFERENCE DIAGNOSTICS, INC. 510(k) NO: K000783(ABBREVIATED)
ATTN: JOSEPH LAWLOR PHONE NO : 781-276-9000
23 CROSBY DR. SE DECISION MADE: 04-MAY-00
BEDFORD, MA 01730-1401 510(k) STATEMENT
DEVICE: ESPIRT
RESPIRONICS CALIFORNIA, INC. 510(k) NO: K001208(SPECIAL)
ATTN: KATHY MOORE PHONE NO : 760-727-3500
1261 LIBERTY WAY SE DECISION MADE: 12-MAY-00
VISTA, CA 92083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001
RETINALABS.COM 510(k) NO: K000416(TRADITIONAL)
ATTN: FRANK TIGHE PHONE NO : 800-793-1473
1776 PEACHTREE STREET SE DECISION MADE: 08-MAY-00
200 NORTH 510(k) SUMMARY AVAILABLE FROM FDA
ATLANTA, GA 30309
DEVICE: SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002,
RETINALABS.COM 510(k) NO: K000420(TRADITIONAL)
ATTN: FRANK TIGHE PHONE NO : 800-793-1473
1776 PEACHTREE STREET SE DECISION MADE: 08-MAY-00
200 NORTH 510(k) SUMMARY AVAILABLE FROM FDA
ATLANTA, GA 30309
DEVICE: VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOF
RETINALABS.COM 510(k) NO: K000457(TRADITIONAL)
ATTN: FRANK TIGHE PHONE NO : 800-793-1473
1776 PEACHTREE STREET SE DECISION MADE: 09-MAY-00
200 NORTH 510(k) SUMMARY AVAILABLE FROM FDA
ATLANTA, GA 30309
DEVICE: RHIGENE MESACUP2 TEST- SSA
RHIGENE, INC 510(k) NO: K000749(TRADITIONAL)
ATTN: DAVE KOLESAR PHONE NO : 847-375-9091
455 STATE ST., SE DECISION MADE: 09-MAY-00
SUITE 104 510(k) STATEMENT
DES PLAINES, IL 60068
DEVICE: RHIGENE MESACUP2 TEST- SCL-70
RHIGENE, INC 510(k) NO: K000750(TRADITIONAL)
ATTN: DAVE KOLESAR PHONE NO : 847-375-9091
455 STATE ST., SE DECISION MADE: 09-MAY-00
SUITE 104 510(k) STATEMENT
DES PLAINES, IL 60068
DEVICE: RHIGENE MESACUP2 TEST- SSB
RHIGENE, INC 510(k) NO: K000751(TRADITIONAL)
ATTN: DAVE KOLESAR PHONE NO : 847-375-9091
455 STATE ST., SE DECISION MADE: 09-MAY-00
SUITE 104 510(k) STATEMENT
DES PLAINES, IL 60068
DEVICE: RHIGENE MESACUP2 TEST- RNP
RHIGENE, INC 510(k) NO: K000752(TRADITIONAL)
ATTN: DAVE KOLESAR PHONE NO : 847-375-9091
455 STATE ST., SE DECISION MADE: 09-MAY-00
SUITE 104 510(k) STATEMENT
DES PLAINES, IL 60068
DEVICE: RHIGENE MESACUP2 TEST- SM
RHIGENE, INC 510(k) NO: K000755(TRADITIONAL)
ATTN: DAVE KOLESAR PHONE NO : 847-375-9091
455 STATE ST., SE DECISION MADE: 09-MAY-00
SUITE 104 510(k) STATEMENT
DES PLAINES, IL 60068
DEVICE: HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.2
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K000673(TRADITIONAL)
ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY. SE DECISION MADE: 26-MAY-00
VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: URETHROTOME 8667.XXX AND 8670.XXX
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K000905(TRADITIONAL)
ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY. SE DECISION MADE: 12-MAY-00
VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM
ROCHE DIAGNOSTICS CORP. 510(k) NO: K000155(TRADITIONAL)
ATTN: KAY A TAYLOR PHONE NO : 317-576-3544
9115 HAGUE RD. SE DECISION MADE: 17-MAY-00
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE CARDIAC READER SYSTEM
ROCHE DIAGNOSTICS CORP. 510(k) NO: K000784(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511
55 NORTHERN BLVD. SE DECISION MADE: 18-MAY-00
SUITE 410 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDRO
ROCHESTER MEDICAL CORP. 510(k) NO: K000723(TRADITIONAL)
ATTN: MARY WILEN PHONE NO : 507-533-9612
ONE ROCHESTER MEDICAL DR. SE DECISION MADE: 19-MAY-00
STEWARTVILLE, MN 55976 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROVERS ENDOCERVEX-BRUSH
ROVERS MEDICAL DEVICES B.V. 510(k) NO: K001119(ABBREVIATED)
ATTN: TODD M GATES PHONE NO : 626-744-9171
960 CHAPEA ROAD SE DECISION MADE: 19-MAY-00
PASADENA, CA 91107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RUSCH EMERGENCY MASK
RUSCH, INC. 510(k) NO: K993528(TRADITIONAL)
ATTN: RONALD YOUNG PHONE NO : 770-623-0816
2450 MEADOWBROOK PKWY. SE DECISION MADE: 31-MAY-00
DULUTH, GA 30096 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ACCUDEXA BONE DENSITOMETER
SCHICK TECHNOLOGIES, INC. 510(k) NO: K001429(SPECIAL)
ATTN: DANIEL MICHAELI PHONE NO : 718-482-2159
31-00 47TH AVE. SE DECISION MADE: 26-MAY-00
LONG ISLAND, NY 11101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIROVIT SP-2, PNEUMOCHECK II
SCHILLER AG 510(k) NO: K992823(TRADITIONAL)
ATTN: MARKUS BUETLER PHONE NO : 414 176 64252
ALTGASSE 68 SE DECISION MADE: 12-MAY-00
CH-6340 BAAR, SWITZERLAND 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IDS5 IMAGE DISPLAY SYSTEM
SECTRA AB 510(k) NO: K001140(SPECIAL)
ATTN: HERMAN OOSTERWIJK PHONE NO : 940-440-9530
2001 EAST OAKSHORES DRIVE SE DECISION MADE: 03-MAY-00
CROSSROADS, TX 76227 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SERIM LEUKOCYTE ESTERASE TEST STRIPS
SERIM RESEARCH CORP. 510(k) NO: K000578(TRADITIONAL)
ATTN: ROBERT J CARRICO PHONE NO : 219-264-3440
23565 REEDY DR. SE DECISION MADE: 05-MAY-00
ELKHART, IN 46514 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
SERV-A-PURE COMPANY 510(k) NO: K993520(TRADITIONAL)
ATTN: RICHARD C HERZBERGER PHONE NO : 517-892-7745
1101 COLUMBUS AVE SE DECISION MADE: 03-MAY-00
BAY CITY, MI 48708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITRILE EXAM GLOVES, POWDER-FREE, COLOR BLUE
SHANGHAI POSEIDON PLASTIC PRODUCTS510(k) NO: K001128(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 23-MAY-00
SPARKS, NV 89434-9550 510(k) STATEMENT
DEVICE: DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR
SHEEN MORE ENT. CO., LTD. 510(k) NO: K001065(TRADITIONAL)
ATTN: KEN HUANG PHONE NO : 886 555 75937
NO.16, TOU KUNG SIX RD. SE DECISION MADE: 23-MAY-00
TOU-LIU EXPANDED INDUST. PARK 510(k) STATEMENT
TOU-LIU, YUN-LIN, CHINA (TAIWAN)
DEVICE: DISPOSABLE POWDERED NITRILE EXAM GLOVE, WHITE COLOR
SHEEN MORE ENT. CO., LTD. 510(k) NO: K001155(TRADITIONAL)
ATTN: KEN HUANG PHONE NO : 011 886 55575937
NO.16, TOU KUNG SIX RD. SE DECISION MADE: 23-MAY-00
TOU-LIU EXPANDED INDUST. PARK 510(k) STATEMENT
TOU-LIU, YUN-LIN, CHINA (TAIWAN)
DEVICE: SHELHIGH NO-REACT DURA SHIELD
SHELHIGH, INC. 510(k) NO: K982101(TRADITIONAL)
ATTN: SHLOMO GABBAY PHONE NO : 973-467-7861
P.O. BOX 884 SE DECISION MADE: 02-MAY-00
MILLBURN, NJ 07041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE NITRILE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMO
SHEN WEI (USA), INC. 510(k) NO: K991422(TRADITIONAL)
ATTN: BELLE L CHOU PHONE NO : 510-429-8692
2845 WHIPPLE RD. SE DECISION MADE: 03-MAY-00
UNION CITY, CA 94587 510(k) STATEMENT
DEVICE: MODIFICATION TO KION ANESTHESIA SYSTEM
SIEMENS ELEMA AB 510(k) NO: K001315(SPECIAL)
ATTN: DAVE SIMARD PHONE NO : 978-907-7737
ELECTROMEDICAL SYSTEMS GROUP SE DECISION MADE: 26-MAY-00
16 ELECTRONICS AVENUE 510(k) SUMMARY AVAILABLE FROM FDA
DANVERS, MA 01923
DEVICE: HELIODENT VARIO
SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K000672(TRADITIONAL)
ATTN: SHEILA HEMEON-HEYER PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 02-MAY-00
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEER III TOTAL SHOULDER SYSTEM
SMITH & NEPHEW, INC. 510(k) NO: K994350(TRADITIONAL)
ATTN: NEAL DEFIBAUGH PHONE NO : 901-399-5363
1450 E. BROOKS ROAD SE DECISION MADE: 23-MAY-00
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLORADO II SPINAL SYSTEM
SOFAMOR DANEK USA,INC. 510(k) NO: K991031(TRADITIONAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 10-MAY-00
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMNUS DISPOSABLE TISSUE COAGULATING ELECTRODE AND SOMNUS REUSAB
SOMNUS MEDICAL TECHNOLOGIES, INC. 510(k) NO: K000720(TRADITIONAL)
ATTN: STEVEN J OJALA PHONE NO : 408-617-3434
285 NORTH WOLFE RD. SE DECISION MADE: 30-MAY-00
SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR
SOMNUS MEDICAL TECHNOLOGIES, INC. 510(k) NO: K001438(SPECIAL)
ATTN: STEVEN J OJALA, PH.D PHONE NO : 408-617-3434
285 NORTH WOLFE RD. SE DECISION MADE: 16-MAY-00
SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WAND PLUS
SPINTECH, INC. 510(k) NO: K992819(TRADITIONAL)
ATTN: DANIEL J MANELLI PHONE NO : 202-261-1000
2000 M STREET, N.W., SUITE 700 SE DECISION MADE: 11-MAY-00
WASHINGTON, DC 20036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX
ST. JUDE MEDICAL, INC. 510(k) NO: K001346(SPECIAL)
ATTN: PAUL CORNELISON PHONE NO : 612-933-4700
14901 DEVEAU PLACE SE DECISION MADE: 24-MAY-00
MINNETONKA, MN 55345 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX
ST. JUDE MEDICAL, INC. 510(k) NO: K001367(SPECIAL)
ATTN: PAUL CORNELISON PHONE NO : 612-933-4700
14901 DEVEAU PLACE SE DECISION MADE: 31-MAY-00
MINNETONKA, MN 55345 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541
STC TECHNOLOGIES, INC. 510(k) NO: K000399(TRADITIONAL)
ATTN: R. SAM NEIDBALA PHONE NO : 610-882-1820
1745 EATON AVE. SE DECISION MADE: 15-MAY-00
BETHLEHEM, PA 18018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA
STC TECHNOLOGIES, INC. 510(k) NO: K001197(SPECIAL)
ATTN: R. SAM NIEDBALA PHONE NO : 610-882-1820
1745 EATON AVE. SE DECISION MADE: 11-MAY-00
BETHLEHEM, PA 18018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMSCO RELIANCE 444 SINGLE-CHAMBER WASHER-DISINFECTOR
STERIS CORP. 510(k) NO: K983068(TRADITIONAL)
ATTN: RAYMOND URSICK PHONE NO : 440-354-2600
5960 HEISELY RD. SE DECISION MADE: 31-MAY-00
MENTOR, OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRA
STERITEC PRODUCTS, INC. 510(k) NO: K001444(SPECIAL)
ATTN: LINDA NELSON PHONE NO : 303-660-4201
599 TOPEKA WAY, SUITE 700 SE DECISION MADE: 15-MAY-00
CASTLE ROCK, CO 80104 510(k) STATEMENT
DEVICE: STRYKER IRRIGATION TUBE SET
STRYKER ENDOSCOPY 510(k) NO: K000493(TRADITIONAL)
ATTN: MARK KUIPER PHONE NO : 408-567-9100
2590 WALSH AVE. SE DECISION MADE: 15-MAY-00
SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLORADO MICRODISSECTION NEEDLE
STRYKER LEIBINGER 510(k) NO: K000348(TRADITIONAL)
ATTN: KRISTYN R KELLEY PHONE NO : 800-253-7370
4100 EAST MILHAM AVE SE DECISION MADE: 03-MAY-00
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOTORIZED MICRO MULTILEAF COLLIMATOR
STRYKER LEIBINGER 510(k) NO: K000349(TRADITIONAL)
ATTN: KRISTYN R KELLEY PHONE NO : 800-253-7370
4100 EAST MILHAM AVE SE DECISION MADE: 03-MAY-00
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BELLEGLASS HP ENAMEL
SYBRON DENTAL SPECIALTIES INC. 510(k) NO: K000530(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 17-MAY-00
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM
SYNTHES (USA) 510(k) NO: K000682(TRADITIONAL)
ATTN: ANGELA J SILVESTRI PHONE NO : 610-647-9700
P.O. BOX 1766 SE DECISION MADE: 01-MAY-00
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222
DEVICE: SHARP BRAND ACUPUNCTURE NEEDLES
TCM SUPPLY CORP. 510(k) NO: K000816(TRADITIONAL)
ATTN: WILLIAM HUNG LEE PHONE NO : 626-968-2600
15946 KAPLAN AVENUE SE DECISION MADE: 04-MAY-00
CITY OF INDUSTRY, CA 91744 510(k) STATEMENT
DEVICE: NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN
TERANG NUSA SDN BHD 510(k) NO: K000178(TRADITIONAL)
ATTN: CHIN-GUAN LOW PHONE NO : 609 773 5133
1 JALAN 8, PENGKALAN CHEPA 2 SE DECISION MADE: 23-MAY-00
INDUSTRIAL ZONE, 510(k) SUMMARY AVAILABLE FROM FDA
KOTA BHARU, KELANTAN, MALAYSIA 16100
DEVICE: NUZONE NITRILE SURGICAL GLOVES POWDER FREE
TERANG NUSA SDN BHD 510(k) NO: K000179(TRADITIONAL)
ATTN: CHIN-GUAN LOW PHONE NO : 609 773 5133
1 JALAN 8, PENGKALAN CHEPA 2 SE DECISION MADE: 15-MAY-00
INDUSTRIAL ZONE, 510(k) STATEMENT
KOTA BHARU, KELANTAN, MALAYSIA 16100
DEVICE: IIVS INTEGRATED IMAGE VIEWING STATION
TERARECON, INC. 510(k) NO: K994329(TRADITIONAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LANE SE DECISION MADE: 26-MAY-00
SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA
PLEASENT HILL, CA 94523-3389
DEVICE: TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER
TFX MEDICAL, INC. 510(k) NO: K000665(ABBREVIATED)
ATTN: KARENANN J BROZOWSKI PHONE NO : 603-532-7706
TALL PINES PARK SE DECISION MADE: 02-MAY-00
JAFFREY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT
THE BINDING SITE, LTD. 510(k) NO: K991801(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
EAST TOWER, SUITE 600 SE DECISION MADE: 05-MAY-00
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT
THE BINDING SITE, LTD. 510(k) NO: K991802(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
EAST TOWER, SUITE 600 SE DECISION MADE: 05-MAY-00
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT.
THE BINDING SITE, LTD. 510(k) NO: K991803(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
EAST TOWER, SUITE 600 SE DECISION MADE: 05-MAY-00
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: BINDAZYME ANTI-B2 SCREEN EIA TEST KIT.
THE BINDING SITE, LTD. 510(k) NO: K991804(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
EAST TOWER, SUITE 600 SE DECISION MADE: 05-MAY-00
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIP
THE OLYMPUS OPTICAL CO. 510(k) NO: K001203(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE CENTER DRIVE SE DECISION MADE: 26-MAY-00
MELVILLE, NY 11747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I
THE OLYMPUS OPTICAL CO. 510(k) NO: K001241(SPECIAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE DRIVE SE DECISION MADE: 09-MAY-00
MELVILLE, NY 11747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLINI-DENT
THE PRECIDENT GROUP 510(k) NO: K000140(TRADITIONAL)
ATTN: WENDY BEDALE PHONE NO : 919-361-2286
200 WESTPARK CORPORATE CENTER SE DECISION MADE: 03-MAY-00
4364 SOUTH ALSTON AVENUE 510(k) SUMMARY AVAILABLE FROM FDA
DURHAM, NC 27713-2280
DEVICE: YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGMACAM
THE YOSHIDA DENTAL MFG. CO., LTD. 510(k) NO: K000577(TRADITIONAL)
ATTN: KIYOSHI YOSHIDA PHONE NO : 813 363 12165
1-3-6, KOTOBASHI, SUMIDA-KU SE DECISION MADE: 05-MAY-00
TOKYO, JAPAN 130 510(k) STATEMENT
DEVICE: CONNECT DATA MANAGEMENT SYSTEM
THERASENSE, INC. 510(k) NO: K994433(TRADITIONAL)
ATTN: EVE A CONNER PHONE NO : 510-749-5400
1360 SOUTH LOOP DR. SE DECISION MADE: 05-MAY-00
ALAMEDA, CA 94502-7000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIRPILOTMASK, MODEL TMS-900
TIARA MEDICAL SYSTEMS, INC. 510(k) NO: K992192(TRADITIONAL)
ATTN: GEOFFREY SLEEPER PHONE NO : 216-521-1220
14414 DETROIT AVENUE #205 SE DECISION MADE: 12-MAY-00
LAKEWOOD, OH 44107 510(k) STATEMENT
DEVICE: SENSI GRIP LATEX EXAMINATION GLOVE, POWDERED CONTAINS 200 MCGM O
TILLOTSON HEALTHCARE CORPORATION 510(k) NO: K000745(TRADITIONAL)
ATTN: THOMAS N TILLOTSON PHONE NO : 603-472-6600
360 ROUTE 101 WEST SE DECISION MADE: 03-MAY-00
BEDFORD, NH 03110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOFTFORM FACIAL IMPLANT
TISSUE TECHNOLOGIES, INC. 510(k) NO: K000849(TRADITIONAL)
ATTN: JESSE KRAMER PHONE NO : 415-885-6269
1370 GREEN ST. SE DECISION MADE: 19-MAY-00
SAN FRANCISCO, CA 94109 510(k) STATEMENT
DEVICE: SURGEN VALVE
TIVA MEDICAL 510(k) NO: K990331(TRADITIONAL)
ATTN: JIM CAPUTO PHONE NO : 760-943-8594
2157 VISTA LA NISA SE DECISION MADE: 31-MAY-00
CARLSBAD, CA 92009 510(k) STATEMENT
DEVICE: SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN)
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K001035(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 440-250-1665
29299 CLEMENS RD. SUITE 1-K SE DECISION MADE: 23-MAY-00
WESTLAKE, OH 44145 510(k) STATEMENT
DEVICE: STANDARD & EXTENDED BLADE, STANDARD & EXTENDED NEEDLE, STANDARD
TRIAD SURGICAL TECHNOLOGIES, INC. 510(k) NO: K000333(TRADITIONAL)
ATTN: BRIAN MCGAVIN PHONE NO : 801-231-0197
7786 PROSPECTOR DR. SE DECISION MADE: 03-MAY-00
SALT LAKE CITY, UT 84121 510(k) STATEMENT
DEVICE: PQ1
ULTRADENT PRODUCTS, INC. 510(k) NO: K000189(TRADITIONAL)
ATTN: SCOTT E MOORE PHONE NO : 800-552-5512
505 WEST 10200 SOUTH SE DECISION MADE: 11-MAY-00
SOUTH JORDAN, UT 84095 510(k) STATEMENT
DEVICE: LIBERTY 9000 BREAST COIL
USA INSTRUMENTS, INC. 510(k) NO: K000993(TRADITIONAL)
ATTN: RONY THOMAS PHONE NO : 330-562-1000
1515 DANNER DRIVE SE DECISION MADE: 26-MAY-00
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOWLER ENDOCURETTE, MODEL CUR-XXX
UTAH MEDICAL PRODUCTS, INC. 510(k) NO: K000974(TRADITIONAL)
ATTN: KEVIN L CORNWELL PHONE NO : 801-566-1200
7043 SOUTH 300 WEST SE DECISION MADE: 23-MAY-00
MIDVALE, UT 84047-1048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROTON VISION
VARIAN ASSOC., INC. 510(k) NO: K000922(TRADITIONAL)
ATTN: LINDA S NASH PHONE NO : 650-493-6990
3100 HANSEN WAY SE DECISION MADE: 24-MAY-00
PALO ALTO, CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITA RESPONSE
VIDENT 510(k) NO: K000597(TRADITIONAL)
ATTN: BARBARA J LEWANDOWSKI PHONE NO : 714-961-6200
3150 EAST BIRCH ST. SE DECISION MADE: 17-MAY-00
BREA, CA 92821 510(k) STATEMENT
DEVICE: WAVESCAN WAVEFRONT SYSTEM MODEL HS 1
VISX, INC. 510(k) NO: K000327(TRADITIONAL)
ATTN: DAVID M PATINO PHONE NO : 408-773-7327
3400 CENTRAL EXPRESSWAY SE DECISION MADE: 02-MAY-00
SANTA CLARA, CA 95051-0703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2
VITROLIFE AB 510(k) NO: K991348(TRADITIONAL)
ATTN: GARY L YINGLING PHONE NO : 202-496-7500
MOLNDALSVAGEN 30 SE DECISION MADE: 17-MAY-00
GOTHENBURG, SWEDEN SE-412 63 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1
VITROLIFE AB/SCANDINAVIAN IVF SCIE510(k) NO: K000618(TRADITIONAL)
ATTN: GARY L YINGLING PHONE NO : 202-496-7645
1900 K STREET, N.W. SE DECISION MADE: 17-MAY-00
WASHINGTON, DC 20006-1108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100
VITROLIFE AB/SCANDINAVIAN IVF SCIE510(k) NO: K000621(TRADITIONAL)
ATTN: GARY L YINGLING PHONE NO : 202-496-7283
1900 K STREET, N.W. SE DECISION MADE: 16-MAY-00
WASHINGTON, DC 20006-1108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1
VITROLIFE AB/SCANDINAVIAN IVF SCIE510(k) NO: K000623(TRADITIONAL)
ATTN: GARY Y YINGLING PHONE NO : 202-496-7283
1900 K STREET, N.W. SE DECISION MADE: 16-MAY-00
WASHINGTON, DC 20006-1108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCANDINAVIAN IVF SCIENCES AB, G1.2
VITROLIFE AB/SCANDINAVIAN IVF SCIE510(k) NO: K000625(TRADITIONAL)
ATTN: GARY Y YINGLING PHONE NO : 202-496-7283
1900 K STREET, N.W. SE DECISION MADE: 23-MAY-00
WASHINGTON, DC 20006-1108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCANDINAVIAN IVF SCIENCES AB, GAMETE-100
VITROLIFE AB/SCANDINAVIAN IVF SCIE510(k) NO: K000626(TRADITIONAL)
ATTN: GARY L YINGLING PHONE NO : 202-496-7283
1900 K STREET, N.W. SE DECISION MADE: 23-MAY-00
WASHINGTON, DC 20006-1108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WAKO LIPASE CALIBRATOR
WAKO CHEMICALS, USA, INC. 510(k) NO: K001002(TRADITIONAL)
ATTN: TONYA MALLORY PHONE NO : 800-992-9256
1600 BELLWOOD RD. SE DECISION MADE: 24-MAY-00
RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM
WALTER LORENZ SURGICAL, INC. 510(k) NO: K001238(SPECIAL)
ATTN: DIANA PRESTON PHONE NO : 904-741-4400
1520 TRADEPORT DR. SE DECISION MADE: 03-MAY-00
JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEOCARE 20 MICRON BLOOD FILTER
WHATMAN, INC. 510(k) NO: K000719(TRADITIONAL)
ATTN: RANDALL D BATH PHONE NO : 734-655-3300
401 WEST MORGAN ROAD SE DECISION MADE: 30-MAY-00
ANN ARBOR, MI 48108-9109 510(k) STATEMENT
DEVICE: AGC-GOLD ELECTROLYTE FOR AGC-MICRO, AGC-GOLD ELECTROLYTE FOR AGC
WIELAND EDELMETALLE GMBH & CO. 510(k) NO: K001041(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 49 723 137050219
SCHWENNINGER STRABE 13 SE DECISION MADE: 23-MAY-00
PFORZHEIM D-75179, GERMANY D-75179510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON S
WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K001280(TRADITIONAL)
ATTN: YUE WAH CHOW PHONE NO : 603 846 1486
LOT 1, JALAN 3, SE DECISION MADE: 15-MAY-00
KAWASAN PERUSAHAAN BANDAR BARU 510(k) SUMMARY AVAILABLE FROM FDA
SALAK TINGGI, SEPANG SELANGOR, MALAYSIA 43900
DEVICE: THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTE
ZEUS SCIENTIFIC, INC. 510(k) NO: K000879(TRADITIONAL)
ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744
200 EVANS WAY SE DECISION MADE: 22-MAY-00
BRANCHBURG, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTE
ZEUS SCIENTIFIC, INC. 510(k) NO: K000880(TRADITIONAL)
ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744
200 EVANS WAY SE DECISION MADE: 22-MAY-00
BRANCHBURG, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEW
ZYMED CORP. 510(k) NO: K001308(SPECIAL)
ATTN: GRETEL LUMLEY PHONE NO : 800-235-5941
1201 "B" N. RICE AVE SE DECISION MADE: 17-MAY-00
OXNARD, CA 93030 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 319
TOTAL WITH SUMMARIES 233
TOTAL WITH STATEMENTS 86
Updated 7/7/2000
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