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510(k)s Final Decisions Rendered for December 2003 |
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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-DEC-2003 THROUGH 31-DEC-2003
DEVICE: IMMEDIATE STABILIZING IMPLANT (ISI)
"O" CO., INC. 510(k) NO: K033392(TRADITIONAL)
ATTN: DAVID D DALISE PHONE NO : 800-228-0477
600 PAISANO, N.E., SUITE A SE DECISION MADE: 10-DEC-03
ALBUQUERQUE, NM 87123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ERGO SRS
3D LINE USA, INC. 510(k) NO: K031281(TRADITIONAL)
ATTN: NADER SALEHI PHONE NO : 410-581-6701
11419 CRONRIDGE RD., STE.15 SE DECISION MADE: 23-DEC-03
OWINGS MILLS, MD 21117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT
A-DEC, INC. 510(k) NO: K032572(TRADITIONAL)
ATTN: TOM LOUISELL PHONE NO : 503-538-9471
2601 CRESTVIEW DR. SE DECISION MADE: 03-DEC-03
NEWBERG, OR 97132-9257 510(k) STATEMENT
DEVICE: A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533
A-DEC, INC. 510(k) NO: K032756(TRADITIONAL)
ATTN: TOM LOUISELL PHONE NO : 503-538-9471
2601 CRESTVIEW DR. SE DECISION MADE: 04-DEC-03
NEWBERG, OR 97132-9257 510(k) STATEMENT
DEVICE: A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LI
A-DEC, INC. 510(k) NO: K032757(TRADITIONAL)
ATTN: TOM LOUISELL PHONE NO : 504-538-9471
2601 CRESTVIEW DR. SE DECISION MADE: 10-DEC-03
NEWBERG, OR 97132-9257 510(k) STATEMENT
DEVICE: VERASOFT ES
AALBA DENT, INC. 510(k) NO: K033356(TRADITIONAL)
ATTN: VINCENT BENETTI PHONE NO : 707-864-3334
400 WATT DR. SE DECISION MADE: 30-DEC-03
CORDELIA, CA 94534 510(k) STATEMENT
DEVICE: SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005,
ABBOTT LABORATORIES 510(k) NO: K033537(SPECIAL)
ATTN: JOANNA KUSKOWSKI PHONE NO : 650-474-3331
400 SAGINAW DRIVE SE DECISION MADE: 10-DEC-03
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIE
ABBOTT LABORATORIES 510(k) NO: K033576(SPECIAL)
ATTN: PATRICIA MELERSKI PHONE NO : 847-938-3718
DEPT. 389, BLDG. J45-2N SE DECISION MADE: 04-DEC-03
200 ABBOTT PARK ROAD 510(k) SUMMARY AVAILABLE FROM FDA
ABBOTT PARK, IL 60064-6133
DEVICE: ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE
ACON LABORATORIES, INC. 510(k) NO: K033299(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 12-DEC-03
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACRA-CUT XPRESS 120
ACRA CUT, INC. 510(k) NO: K032970(TRADITIONAL)
ATTN: KENNETH M NICOLL PHONE NO : 603-672-3161
74 SPRING ROAD SE DECISION MADE: 08-DEC-03
AMHERST, NH 03031 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANTAGE PRO ATTENUATION CORRECTION DEVICE
ADAC LABORATORIES 510(k) NO: K033735(TRADITIONAL)
ATTN: CHARLENE BRUMBAUGH PHONE NO : 408-468-3619
540 ALDER DR. SE DECISION MADE: 12-DEC-03
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: LAMITRODE SPINAL CORD STIMULATION LEADS
ADVANCED NEUROMODULATION SYSTEMS 510(k) NO: K033429(SPECIAL)
ATTN: DANIELLE ALARCON PHONE NO : 972-309-8559
6501 WINDCREST DRIVE SUITE 100 SE DECISION MADE: 04-DEC-03
PLANO, TX 75024 510(k) STATEMENT
DEVICE: AESKULISA ANA 8PRO
AESKU, INC 510(k) NO: K032469(TRADITIONAL)
ATTN: STANLEY AMMONS PHONE NO : 703-860-5057
8880 NORTHWEST 18TH TERRACE SE DECISION MADE: 16-DEC-03
MIAMI, FL 33172 510(k) STATEMENT
DEVICE: INSTAREAD LITHIUM SYSTEM
AKERS LABORATORIES, INC. 510(k) NO: K031579(TRADITIONAL)
ATTN: ERIKA B AMMIRATI PHONE NO : 856-848-8698
201 GROVE RD. SE DECISION MADE: 19-DEC-03
THOROFARE, NJ 08086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EUSOL-C
ALCHIMIA SRL 510(k) NO: K032422(TRADITIONAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 S SE DECISION MADE: 15-DEC-03
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEPARIN LOCK FLUSH SYRINGE
AM2 PAT INC. 510(k) NO: K032417(TRADITIONAL)
ATTN: DUSHYANT PATEL PHONE NO : 919-552-9689
9400 RANSDELL RD., SUITE 10 SE DECISION MADE: 23-DEC-03
RALEIGH, NC 27603 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TANGO, MODELS, BP1
AMERICAN BANTEX CORP. 510(k) NO: K031711(TRADITIONAL)
ATTN: TRACY S BEST PHONE NO : 801-295-0748
994 NORTH MAIN STREET SE DECISION MADE: 18-DEC-03
BOUNTIFUL, UT 84010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREA
AMERICAN GREEN DENT. MFG, INC. 510(k) NO: K033045(TRADITIONAL)
ATTN: ANDREW ROWE PHONE NO : 323-265-7000
3432 E. 14TH STREET SE DECISION MADE: 23-DEC-03
LOS ANGELES, CA 90023 510(k) STATEMENT
DEVICE: AMS LARGE PORE POLYPROPYLENE MESH
AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K033636(TRADITIONAL)
ATTN: ELSA A LINKE PHONE NO : 952-930-6000
10700 BREN RD., WEST SE DECISION MADE: 31-DEC-03
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFESTYLES LIQUID PERSONAL LUBRICANT
ANSELL HEALTHCARE, INC. 510(k) NO: K033076(TRADITIONAL)
ATTN: LON D MCILVAIN PHONE NO : 334-615-2562
1635 INDUSTRIAL RD. SE DECISION MADE: 19-DEC-03
DOTHAN, AL 36303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LA500 BLUE LIGHT
APOZA ENTERPRISE CO. LTD. 510(k) NO: K033201(TRADITIONAL)
ATTN: SHIH MIN-TEH PHONE NO : 886 229 010620
6 F,NO.657, CHUANG CHENG ROAD SE DECISION MADE: 02-DEC-03
HSIN-CHUANG CITY 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI HSIEN, CHINA (TAIWAN) 242
DEVICE: MEDICAL IMAGE DIGITIZER, MODEL 2908
ARRAY CORP. 510(k) NO: K033637(SPECIAL)
ATTN: TAKASHI INAMI PHONE NO : 011 81 333203911
3-42-10 YOYOGI SE DECISION MADE: 17-DEC-03
SHIBUYA-KU, TOKYO, JAPAN 151-0053 510(k) STATEMENT
DEVICE: ASEPTICO ENDOPEX V, MODEL AEU-40
ASEPTICO, INC. 510(k) NO: K030895(TRADITIONAL)
ATTN: GRANT RAMALEY PHONE NO : 425-487-3157
8333 216TH ST., S.E. SE DECISION MADE: 03-DEC-03
WOODINVILLE, WA 98072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATHENA PELVIC MUSCLE TRAINER II
ATHENA FEMININE TECHNOLOGIES, INC.510(k) NO: K033256(ABBREVIATED)
ATTN: BARBARA SARKIS PHONE NO : 925-254-6090
179 MORAGA WAY SE DECISION MADE: 30-DEC-03
ORINDA, CA 94563-3442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALT LASER, MODEL VTR 75
AVICENNA LASER TECHNOLOGY, INC. 510(k) NO: K031612(TRADITIONAL)
ATTN: BRUCE R COREN PHONE NO : 561-722-1153
1209 NORTH FLAGLER DRIVE SE DECISION MADE: 11-DEC-03
WEST PALM BEACH, FL 33401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKS
AXON SYSTEMS, INC. 510(k) NO: K032741(TRADITIONAL)
ATTN: HOWARD BAILIN PHONE NO : 631-436-5112
400-2200 OSER AVE. SE DECISION MADE: 16-DEC-03
HAUPPAUGE, NY 11788 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENTURI PHACO PACK
BAUSCH & LOMB, INC. 510(k) NO: K033653(SPECIAL)
ATTN: DENNIS POZZO PHONE NO : 636-226-3183
3365 TREE CT. INDUSTRIAL BLVD. SE DECISION MADE: 17-DEC-03
ST. LOUIS, MO 63122-6694 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAY AREA HYPERSCIENCES
BAY AREA HYPERSCIENCES, LLC 510(k) NO: K030713(ABBREVIATED)
ATTN: EDWARD F GOOD PHONE NO : 714-332-6519
18213 SANDY COVE SE DECISION MADE: 19-DEC-03
HOUSTON, TX 77058 510(k) STATEMENT
DEVICE: BAYER SPECIAL CHEMISTRY CONTROLS
BAYER DIAGNOSTICS CORP. 510(k) NO: K033379(ABBREVIATED)
ATTN: ANDRES HOLLE PHONE NO : 914-524-3494
511 BENEDICT AVE. SE DECISION MADE: 19-DEC-03
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYER SPECIAL CHEMISTRY CALIBRATORS
BAYER DIAGNOSTICS CORP. 510(k) NO: K033380(ABBREVIATED)
ATTN: ANDRES HOLLE PHONE NO : 914-524-3494
511 BENEDICT AVE. SE DECISION MADE: 16-DEC-03
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYER RAPIDLAB 1200 SYSTEM
BAYER HEALTHCARE, LLC 510(k) NO: K031560(TRADITIONAL)
ATTN: MARY E GRAY PHONE NO : 508-359-3825
63 NORTH ST. SE DECISION MADE: 17-DEC-03
MEDFIELD, MA 02052-1688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYER CLINITEK STATUS ANALYZER
BAYER HEALTHCARE, LLC 510(k) NO: K031947(TRADITIONAL)
ATTN: MARY E GRAY PHONE NO : 508-359-3826
63 NORTH ST. SE DECISION MADE: 19-DEC-03
MEDFIELD, MA 02052-1688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLINITEST HCG PREGNANCY TEST
BAYER HEALTHCARE, LLC 510(k) NO: K032563(TRADITIONAL)
ATTN: MARY GRAY PHONE NO : 508-359-3826
63 NORTH ST. SE DECISION MADE: 23-DEC-03
MEDFIELD, MA 02052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75
BAYLIS MEDICAL CO., INC. 510(k) NO: K031949(TRADITIONAL)
ATTN: AMANDA HARTLEY PHONE NO : 905 602 4875
5160 EXPLORER DR. #33 SE DECISION MADE: 10-DEC-03
MISSISSAUGA, ONTARIO, CANADA L4W 4510(k) STATEMENT
DEVICE: BEBIG ISOSEED I-125
BEBIG ISOTOPEN-UND MEDIZINTECHNIK 510(k) NO: K033781(SPECIAL)
ATTN: SVEN LANGER PHONE NO : 493 094 1084176
ROBERT-ROSSLE/STR.10 SE DECISION MADE: 30-DEC-03
BERLIN, GERMANY 13125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY
BECKMAN COULTER, INC. 510(k) NO: K033038(TRADITIONAL)
ATTN: BRENT TABER PHONE NO : 952-368-1323
1000 LAKE HAZELTINE DR. SE DECISION MADE: 29-DEC-03
CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOAS
BECKMAN COULTER, INC. 510(k) NO: K033603(TRADITIONAL)
ATTN: VALYNDA MACHEN PHONE NO : 952-368-1383
1000 LAKE HAZELTINE DR. SE DECISION MADE: 19-DEC-03
CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM 0.5-64 UG/M
BECTON, DICKINSON AND COMPANY 510(k) NO: K033558(TRADITIONAL)
ATTN: BRADFORD SPRING PHONE NO : 410-316-4206
7 LOVETON CIR. SE DECISION MADE: 19-DEC-03
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: (MULTIPLE LABELS) POWDER-FREE VINYL EXAMINATION GLOVES
BERNARD TECHNOLOGIES, INC. 510(k) NO: K033229(TRADITIONAL)
ATTN: MICHAEL D LELAH, PHD PHONE NO : 312-337-0505
75 EAST WACKER DRIVE SE DECISION MADE: 17-DEC-03
CHICAGO, IL 60601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL
BIO-RAD 510(k) NO: K033366(TRADITIONAL)
ATTN: MARIA ZEBALLOS PHONE NO : 949-598-1367
9500 JERONIMO RD. SE DECISION MADE: 12-DEC-03
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945
BIO-RAD 510(k) NO: K033387(TRADITIONAL)
ATTN: MARIA ZEBALLOS PHONE NO : 949-598-1200
9500 JERONIMO RD. SE DECISION MADE: 02-DEC-03
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES)
BIO-RAD 510(k) NO: K033404(TRADITIONAL)
ATTN: MARIA ZEBALLOS PHONE NO : 949-598-1367
9500 JERONIMO RD. SE DECISION MADE: 12-DEC-03
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMNIOLENS
BIO-TISSUE, INC. 510(k) NO: K032104(TRADITIONAL)
ATTN: DAVID J BLOCH PHONE NO : 202-414-9209
1301 K STREET, N.W. SE DECISION MADE: 12-DEC-03
WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LARYNGEAL AUGMENTATION IMPLANT
BIOFORM, INC. 510(k) NO: K033398(TRADITIONAL)
ATTN: JAMES MILLER PHONE NO : 650-286-4000
1875 SOUTH GRANT ST.,SUITE 11O SE DECISION MADE: 12-DEC-03
SAN MATEO, CA 94402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MBCP
BIOMATLANTE 510(k) NO: K032268(TRADITIONAL)
ATTN: MYRIAM VINCENT PHONE NO : 332 280 20009
5, RUE EDOUARD BELIN SE DECISION MADE: 11-DEC-03
VIGNEUX DE BRETAGNE, FRANCE 44360 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALACOS R BONE CEMENT WITH GENTAMICIN
BIOMET, INC. 510(k) NO: K030086(TRADITIONAL)
ATTN: LONNIE WITHAM PHONE NO : 574-372-1510
56 BELL DR. SE DECISION MADE: 17-DEC-03
PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: COMPRESS DISTAL FEMORAL REPLACEMENT
BIOMET, INC. 510(k) NO: K031804(TRADITIONAL)
ATTN: GARY BAKER PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 18-DEC-03
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM
BIOMET, INC. 510(k) NO: K033280(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 19-DEC-03
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET
BIOMET, INC. 510(k) NO: K033519(SPECIAL)
ATTN: GARY BAKER PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 05-DEC-03
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MOD
BIOSITE INCORPORATED 510(k) NO: K033383(TRADITIONAL)
ATTN: JEFFREY R DAHLEN, PH.D. PHONE NO : 858-455-4808
11030 ROSELLE ST. SE DECISION MADE: 23-DEC-03
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
BIOTRONIK, INC. 510(k) NO: K033613(SPECIAL)
ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374
6024 JEAN RD. SE DECISION MADE: 08-DEC-03
LAKE OSWEGO, OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXACTRAC GATING
BRAINLAB AG 510(k) NO: K033287(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 49 89 9915680
AMMERTHALSTRASSE 8 SE DECISION MADE: 19-DEC-03
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRUNO ELECTRA-RIDE STAIRWAY ELEVATOR SYSTEM. MODEL SRE-1540
BRUNO INDEPENDENT LIVING AIDS, INC510(k) NO: K033752(SPECIAL)
ATTN: RICHARD A KELLER PHONE NO : 262-953-5336
1780 EXECUTIVE DR. SE DECISION MADE: 12-DEC-03
P.O. BOX 84 510(k) STATEMENT
OCONOMOWOC, WI 53066
DEVICE: BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM, MODEL CRE-2100
BRUNO INDEPENDENT LIVING AIDS, INC510(k) NO: K033829(SPECIAL)
ATTN: RICHARD KELLER PHONE NO : 262-953-5336
1780 EXECUTIVE DR. SE DECISION MADE: 29-DEC-03
P.O. BOX 84 510(k) STATEMENT
OCONOMOWOC, WI 53066
DEVICE: BTG SMARTEST GLUCOSE TEST SYSTEM
BT MEDICAL 510(k) NO: K032029(TRADITIONAL)
ATTN: DEBBIE CHENG PHONE NO : 886 4 23508198
6F-5 # 210 38TH ROAD SE DECISION MADE: 18-DEC-03
TAICHUNG INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
TAICHUNG, CHINA (TAIWAN)
DEVICE: IRRIGATION CHANNEL TUBING, MODEL 100135
BYRNE MEDICAL, INC. 510(k) NO: K033695(TRADITIONAL)
ATTN: J. HARVEY KNAUSS PHONE NO : 832-285-9423
11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 23-DEC-03
HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FASTRAC GASTRIC ACCESS PORT KIT
C.R. BARD, INC. 510(k) NO: K033562(SPECIAL)
ATTN: THOMAS HIRTE, P.E. PHONE NO : 978-262-4867
129 CONCORD ROAD SE DECISION MADE: 12-DEC-03
BUILDING 3 510(k) SUMMARY AVAILABLE FROM FDA
BILLERICA, MA 01821
DEVICE: MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT
C.R. BARD, INC. 510(k) NO: K033778(SPECIAL)
ATTN: FRAN HARRISON PHONE NO : 770-784-6257
8195 INDUSTRIAL BLVD SE DECISION MADE: 30-DEC-03
COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANDELA SMOOTHBEAM LASER SYSTEM
CANDELA CORP. 510(k) NO: K030834(TRADITIONAL)
ATTN: LORRAINE C PATROVIC PHONE NO : 508-358-7637
530 BOSTON POST RD. SE DECISION MADE: 03-DEC-03
WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PACS SOFTWARE SOLUTION 2003
CANON U.S.A., INC. 510(k) NO: K033624(SPECIAL)
ATTN: SEAN M CURRY PHONE NO : 858-675-8200
16787 BERNARDO CENTER DRIVE SE DECISION MADE: 15-DEC-03
SUITE A1 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92128-3616
DEVICE: H/S CATHETER SET
CATHETER RESEARCH, INC. 510(k) NO: K032835(TRADITIONAL)
ATTN: JOHN A STEEN PHONE NO : 317-872-0074
6131 WEST 80TH ST. SE DECISION MADE: 11-DEC-03
INDIANAPOLIS, IN 46278 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD LEYCOM PRESSURE/VOLUME CATHETERS
CD LEYCOM BV 510(k) NO: K031599(SPECIAL)
ATTN: T. LOPES PHONE NO : 31 79 3601780
ARGONSTRAAT 116 SE DECISION MADE: 09-DEC-03
ZOETERMEER, NETHERLANDS 2718 SP 510(k) STATEMENT
DEVICE: CLINICAL LASETTE P-200
CELL ROBOTICS, INC. 510(k) NO: K033799(SPECIAL)
ATTN: LINDA A BLAIR PHONE NO : 505-343-1131
2715 BROADBENT PARKWAY, NE SE DECISION MADE: 22-DEC-03
SUITE A-E 510(k) SUMMARY AVAILABLE FROM FDA
ALBUQUERQUE, NM 87107
DEVICE: MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM
CENTERPULSE ORTHOPEDICS, INC. 510(k) NO: K033664(SPECIAL)
ATTN: JEAN ASQUITH PHONE NO : 512-432-9900
9900 SPECTRUM DR. SE DECISION MADE: 17-DEC-03
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM
CHATTANOOGA GROUP 510(k) NO: K031077(TRADITIONAL)
ATTN: CHERYL L BAGWELL PHONE NO : 423-870-7207
4717 ADAMS RD. SE DECISION MADE: 11-DEC-03
HIXSON, TN 37343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VECTRA (INTELECT) EPR ULTRASOUND
CHATTANOOGA GROUP 510(k) NO: K031116(TRADITIONAL)
ATTN: MICK DAVIS PHONE NO : 423-870-2281
4717 ADAMS RD. SE DECISION MADE: 03-DEC-03
P.O. BOX 489 510(k) STATEMENT
HIXSON, TN 37343
DEVICE: DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)
CHF SOLUTIONS, INC. 510(k) NO: K031689(TRADITIONAL)
ATTN: AMY PETERSON PHONE NO : 763-463-4620
SUITE 170-7601 NORTHLAND DR. SE DECISION MADE: 23-DEC-03
BROOKLYN PARK, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)
CHROMA VISION MEDICAL SYSTEMS INC.510(k) NO: K032113(TRADITIONAL)
ATTN: DAVID DAVIS PHONE NO : 949-443-3355
33171 PASEO CERVEZA SE DECISION MADE: 23-DEC-03
SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVE
CIBA VISION CORP. 510(k) NO: K033701(SPECIAL)
ATTN: ALICIA M PLESNARSKI PHONE NO : 678-415-3924
11440 JOHNS CREEK PKWY. SE DECISION MADE: 15-DEC-03
DULUTH, GA 30097-1556 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARTOOTH DIGITAL X-RAY SYSTEM
CLEARTOOTH ELECTRONICS, INC. 510(k) NO: K033147(TRADITIONAL)
ATTN: GREG HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 30-DEC-03
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPAK ACRYLIC REPAIR RESIN LIQUID
CMP INDUSTRIES LLC. 510(k) NO: K033020(TRADITIONAL)
ATTN: WILLIAM REGAN PHONE NO : 518-434-3147
413 NORTH PEARL ST. SE DECISION MADE: 19-DEC-03
ALBANY, NY 12207 510(k) STATEMENT
DEVICE: COAPT ENDOTINE CHIN 3.5 DEVICE
COAPT SYSTEMS, INC. 510(k) NO: K033524(TRADITIONAL)
ATTN: LORI DONDIEGO PHONE NO : 650-461-7600
1820 EMBARCADERO RD. SE DECISION MADE: 18-DEC-03
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL
COBE CARDIOVASCULAR, INC. 510(k) NO: K033641(SPECIAL)
ATTN: LYNNE LEONARD PHONE NO : 303-467-6194
14401 WEST 65TH WAY SE DECISION MADE: 11-DEC-03
ARVADA, CO 80004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003
COEUR MEDICAL 510(k) NO: K032920(TRADITIONAL)
ATTN: DEBRA F MANNING PHONE NO : 252-946-1963
209 CREEKSIDE DR. SE DECISION MADE: 16-DEC-03
WASHINGTON, NC 27889 510(k) STATEMENT
DEVICE: COMFORT VARIOUS OF STANDING WHEELCHAIR, HERO 2
COMFORT ORTHOPEDIC CO. LTD. 510(k) NO: K031618(TRADITIONAL)
ATTN: ERIC H.C. LEE PHONE NO : 886 5 2892093
NO. 120 NAN SHIANG TSUEN, SE DECISION MADE: 18-DEC-03
SHOEI SHANG SHIANG 510(k) STATEMENT
CHIA-YI, CHINA (TAIWAN)
DEVICE: CONDUCTIVE EEG ELECTROLYTE
COMPUMEDICS USA, LTD. 510(k) NO: K033052(ABBREVIATED)
ATTN: ELVIRA GARCIA PHONE NO : 915-225-0303
7850 PASEO DEL NORTE SE DECISION MADE: 17-DEC-03
EL PASO, TX 79912 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XIO RADIATION TREATMENT PLANNING SYSTEM
COMPUTERIZED MEDICAL SYSTEMS, INC.510(k) NO: K032762(TRADITIONAL)
ATTN: KATHRYN STINSON PHONE NO : 314-993-0003
1145 CORPORATE LAKE DR. SE DECISION MADE: 02-DEC-03
ST. LOUIS, MO 63132-1716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZILVER 518 BILIARY STENT
COOK, INC. 510(k) NO: K033348(SPECIAL)
ATTN: LELAND KEYT PHONE NO : 800-346-2686
750 DANIELS WAY SE DECISION MADE: 15-DEC-03
P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA
BLOOMINGTON, IN 47402-0489
DEVICE: CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .03
CORDIS CORP. 510(k) NO: K033394(SPECIAL)
ATTN: KAREN WILK PHONE NO : 908-412-7257
7 POWDER HORN DR. SE DECISION MADE: 22-DEC-03
WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OB1 OBSTETRICAL DOPPLER
D. E. HOKANSON, INC. 510(k) NO: K033156(TRADITIONAL)
ATTN: D. EUGENE HOKANSON PHONE NO : 425-882-1689
12840 N.E. 21ST PL. SE DECISION MADE: 09-DEC-03
BELLEVUE, WA 98005-1910 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI
DADE BEHRING, INC. 510(k) NO: K033487(TRADITIONAL)
ATTN: GEORGE M PLUMMER PHONE NO : 302-631-9798
P.O. BOX 6101 BUILDING 500 SE DECISION MADE: 24-DEC-03
GLASGOW BUSINESS COMMUNITY 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK,, DE 19714
DEVICE: AUTOMOVE, MODEL AM800
DANMETER A/S 510(k) NO: K032955(ABBREVIATED)
ATTN: HANNE NIELSEN PHONE NO : 45 63 112930
KILDEMOSEVEJ 13 SE DECISION MADE: 15-DEC-03
ODENSE C, DENMARK DK-5000 510(k) STATEMENT
DEVICE: ELPHA 4 CONTI
DANMETER A/S 510(k) NO: K032988(ABBREVIATED)
ATTN: HANNE NIELSEN PHONE NO : 45 63 112930
KILDEMOSEVEJ 13 SE DECISION MADE: 03-DEC-03
ODENSE C, DENMARK DK-5000 510(k) STATEMENT
DEVICE: POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR
DATEX-OHMEDA, INC. 510(k) NO: K031124(TRADITIONAL)
ATTN: AL VAN HOUDT PHONE NO : 425-657-7200
5150 220TH AVE SE SE DECISION MADE: 04-DEC-03
ISSAQUAH, WA 98029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOBCAT PRO SCALER SYSTEM, MODEL G-130
DENTSPLY INTERNATIONAL 510(k) NO: K033705(SPECIAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE. SE DECISION MADE: 04-DEC-03
P.O. BOX 872 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: PFZ PORCELAIN SYSTEM
DENTSPLY INTL. 510(k) NO: K033553(SPECIAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE. SE DECISION MADE: 02-DEC-03
YORK, PA 17405-0872 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY ASR RESURFACING FEMORAL HEADS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K032659(TRADITIONAL)
ATTN: NATALIE HECK PHONE NO : 574-372-7469
700 ORTHOPAEDIC DR. SE DECISION MADE: 04-DEC-03
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K033516(SPECIAL)
ATTN: TIFFANI D ROGERS PHONE NO : 574-371-4927
700 ORTHOPAEDIC DR. SE DECISION MADE: 03-DEC-03
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K033234(TRADITIONAL)
ATTN: EDWARD LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 12-DEC-03
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MISSION CONTROLS
DIAMOND DIAGNOSTICS, INC. 510(k) NO: K033063(TRADITIONAL)
ATTN: LINDA M STUNDTNER PHONE NO : 508-429-0450
331 FISKE ST. SE DECISION MADE: 12-DEC-03
HOLLISTON, MA 01746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPH
DIDECO S.P.A. 510(k) NO: K033714(SPECIAL)
ATTN: BARRY SALL PHONE NO : 781-434-4742
195 WEST ST. SE DECISION MADE: 11-DEC-03
WALTHAM, MA 02451-1163 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUSOFT
DIREX SYSTEMS CORP. 510(k) NO: K032171(TRADITIONAL)
ATTN: LARISA GERSHTEIN PHONE NO : 188-874-7837
11 MERCER RD. SE DECISION MADE: 15-DEC-03
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM)
DISC-O-TECH MEDICAL TECHNOLOGIES, 510(k) NO: K032358(TRADITIONAL)
ATTN: JONANTHAN S KAHN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 17-DEC-03
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINITY GAMMAXL
DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K033600(SPECIAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 11-DEC-03
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
EBI, L.P. 510(k) NO: K033635(SPECIAL)
ATTN: FREDERIC TESTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 03-DEC-03
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY S
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K032900(TRADITIONAL)
ATTN: DAUN PUTNAM PHONE NO : 949-250-2217
ONE EDWARDS WAY SE DECISION MADE: 04-DEC-03
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMI
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K033250(TRADITIONAL)
ATTN: JASON SMITH PHONE NO : 949-250-2662
ONE EDWARDS WAY SE DECISION MADE: 30-DEC-03
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLASMACURE BXE
EELE LABORATORIES, LLC 510(k) NO: K033795(TRADITIONAL)
ATTN: ROBERT GRASMAN PHONE NO : 631-244-0051
50 ORVILLE DRIVE SE DECISION MADE: 19-DEC-03
BOHEMIA, NY 11716 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: EPW FOLDABLE POWER WHEELCHAIR, EPW-03
EMG TECHNOLOGY CO., LTD. 510(k) NO: K033206(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 3 5208829
NO. 58, FU-CHINU ST. SE DECISION MADE: 18-DEC-03
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) STATEMENT
DEVICE: MULTI-STRAP FULL FACE MASK
ENGINEERED MEDICAL SYSTEMS 510(k) NO: K023683(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 317-335-3780
6329 W. WATERVIEW CT. SE DECISION MADE: 01-DEC-03
MCCORDSVILLE, IN 46055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERICHEK BICARB PH REAGENT STRIPS
ENVIRONMENTAL TEST SYSTEMS, INC. 510(k) NO: K031267(TRADITIONAL)
ATTN: DAVID A MORRIS PHONE NO : 219-262-2060
23575 COUNTY RD. 106 SE DECISION MADE: 23-DEC-03
ELKHART, IN 46514 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAP3 BONE SUBSTITUTE MATERIAL
ETEX CORP. 510(k) NO: K033138(TRADITIONAL)
ATTN: PAMELA W ADAMS PHONE NO : 617-577-7270
38 SIDNEY STREET SE DECISION MADE: 02-DEC-03
CAMBRIDGE, MA 02139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE R
ETHICON ENDO-SURGERY, INC. 510(k) NO: K033269(TRADITIONAL)
ATTN: GEORGIA C ABERNATHY PHONE NO : 513-337-3179
4545 CREEK RD. SE DECISION MADE: 10-DEC-03
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GYNECARE TVT OBTURATOR SYSTEM
ETHICON, INC. 510(k) NO: K033568(SPECIAL)
ATTN: SEAN O'BRYAN PHONE NO : 908-218-2456
ROUTE 22 WEST SE DECISION MADE: 08-DEC-03
SOMERVILLE, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE
ETHICON, INC. 510(k) NO: K033746(SPECIAL)
ATTN: REY LIBROJO PHONE NO : 908-218-3198
ROUTE 22 WEST SE DECISION MADE: 18-DEC-03
SOMERVILLE, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607
EVERYWAY MEDICAL INSTRUMENTS CO., 510(k) NO: K033544(SPECIAL)
ATTN: JAY MANSOUR PHONE NO : 770-777-4146
1308 MORNINGSIDE PARK DR. SE DECISION MADE: 10-DEC-03
ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE
FACILAI ENTERPRISES LTD. 510(k) NO: K031818(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 03-DEC-03
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) STATEMENT
DEVICE: MONA LISA ASPIRATION NEEDLE
FERTILITY TECHNOLOGY RESOURCES, IN510(k) NO: K032208(TRADITIONAL)
ATTN: CONSTANCE W STURGEON PHONE NO : 770-641-9487
4343 SHALLOWFORD RD. SE DECISION MADE: 09-DEC-03
SUITE D-4 510(k) STATEMENT
MARIETTA, GA 30062
DEVICE: SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES
FINK ENGINEERING PTY LTD 510(k) NO: K031649(ABBREVIATED)
ATTN: W.T. WORKMAN PHONE NO : 210-490-6999
18111 COPPER RIDGE DRIVE SE DECISION MADE: 05-DEC-03
SAN ANTONIO, TX 78259 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO TELEGRAPH HUMERAL NAIL
FOURNITURES HOSPITALIERES INDUSTRI510(k) NO: K033510(SPECIAL)
ATTN: CHRISTINE QUENDEZ PHONE NO : 33 2 98556895
ZI DE KERNEVEZ-6 RUE NOBEL SE DECISION MADE: 03-DEC-03
QUIMPER, FRANCE 29000 510(k) STATEMENT
DEVICE: SUBTALAR ARTHRORISIS IMPLANT
FUTURA BIOMEDICAL 510(k) NO: K032902(TRADITIONAL)
ATTN: LOUISE M FOCHT PHONE NO : 760-599-1670
990 PARK CENTER DR., SUITE H SE DECISION MADE: 15-DEC-03
VISTA, CA 92083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUBTALAR PEG IMPLANT
FUTURA BIOMEDICAL 510(k) NO: K033046(TRADITIONAL)
ATTN: LOUISE M FOCHT PHONE NO : 760-599-1670
990 PARK CENTER DR., SUITE H SE DECISION MADE: 23-DEC-03
VISTA, CA 92083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE
GALT MEDICAL CORP. 510(k) NO: K033542(SPECIAL)
ATTN: DAVID CATLIN PHONE NO : 972-271-5177
2475 MERRITT DR. SE DECISION MADE: 05-DEC-03
GARLAND, TX 75041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MYOLIGHT
GE MEDICAL SYSTEMS F.I. HAIFA 510(k) NO: K033874(TRADITIONAL)
ATTN: LAURENCE BIGIO PHONE NO : 4 856 3633
4 HAYOZMA ST. SE DECISION MADE: 30-DEC-03
TIRAT HACARMEL, ISRAEL 30200 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO UNITY NETWORK ID
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K033672(SPECIAL)
ATTN: DIANA M THORSON PHONE NO : 714-247-4135
8200 WEST TOWER AVE. SE DECISION MADE: 18-DEC-03
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENO ADVANTAGE
GE MEDICAL SYSTEMS W-400 510(k) NO: K033400(TRADITIONAL)
ATTN: LARRY A KROGER, PH.D. PHONE NO : 262-544-3894
3000 NORTH GRANDVIEW BLVD. SE DECISION MADE: 04-DEC-03
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIF
GEMORE TECHNOLOGY CO., LTD. 510(k) NO: K032719(TRADITIONAL)
ATTN: BODEN S.P. LAI PHONE NO : 886 2 88091799
11 FL, NO. 29-5, SEC. 2 SE DECISION MADE: 10-DEC-03
CHUNG CHENG E. RD. 510(k) SUMMARY AVAILABLE FROM FDA
TAN SHUI, TAIPEI HSIEN, CHINA (TAIWAN)
DEVICE: GEM-STIM TENS, MODELS GM3XY AND GM3AXY
GEMORE TECHNOLOGY CO., LTD. 510(k) NO: K032720(TRADITIONAL)
ATTN: BODEN S.P. LAI PHONE NO : 886 2 88091799
11 FL, NO. 29-5, SEC. 2 SE DECISION MADE: 10-DEC-03
CHUNG CHENG E. RD. 510(k) SUMMARY AVAILABLE FROM FDA
TAN SHUI, TAIPEI HSIEN, CHINA (TAIWAN)
DEVICE: GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFE
GEMORE TECHNOLOGY CO., LTD. 510(k) NO: K032994(TRADITIONAL)
ATTN: BODEN S.P. LAI PHONE NO : 886 2 88091799
11 FL, NO. 29-5, SEC. 2 SE DECISION MADE: 16-DEC-03
CHUNG CHENG E. RD. 510(k) SUMMARY AVAILABLE FROM FDA
TAN SHUI, TAIPEI HSIEN, CHINA (TAIWAN)
DEVICE: TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC A
GEN-PROBE, INC. 510(k) NO: K032194(TRADITIONAL)
ATTN: WAYNE A KVETKOSKY PHONE NO : 858-410-8543
10210 GENETIC CENTER DR. SE DECISION MADE: 24-DEC-03
SAN DIEGO, CA 92121-4362 510(k) STATEMENT
DEVICE: GEN-PROBE APTIMA COMBO 2 ASSAY
GEN-PROBE, INC. 510(k) NO: K032554(TRADITIONAL)
ATTN: ALAN MADERAZO PHONE NO : 858-410-8332
10808 WILLOW CT. SE DECISION MADE: 31-DEC-03
SAN DIEGO, CA 92127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAZYME LITHIUM ENZYMATIC ASSAY KIT
GENERAL ATOMICS 510(k) NO: K033360(TRADITIONAL)
ATTN: CHONG YUAN PHONE NO : 858-455-4754
3550 GENERAL ATOMICS COURT SE DECISION MADE: 23-DEC-03
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS
GENERAL ELECTRIC CO. 510(k) NO: K033867(SPECIAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
P.O. BOX 414 SE DECISION MADE: 19-DEC-03
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VACUETTE QUICKSHIELD SAFETY TUBE HOLDER
GREINER BIO-ONE VACUETTE NORTH AME510(k) NO: K033478(TRADITIONAL)
ATTN: JUDI SMITH PHONE NO : 410-592-2060
PO BOX 103 SE DECISION MADE: 29-DEC-03
BALDWIN, MD 21013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISU-LOCK 5MM CLIP APPLIER
GYRX, LLC 510(k) NO: K033161(TRADITIONAL)
ATTN: CORY EDWARDS PHONE NO : 904-641-2599
11222 ST. JOHNS INDUSTRIAL SE DECISION MADE: 18-DEC-03
PARKWAY N. 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32246
DEVICE: HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP
HARVARD CLINICAL TECHNOLOGY 510(k) NO: K033054(TRADITIONAL)
ATTN: ERIC J FLACHBART PHONE NO : 508-655-2000
22 PLEASANT ST. SE DECISION MADE: 16-DEC-03
SOUTH NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HEMEDEX FIXATION DEVICE
HEMEDEX INCORPORATED 510(k) NO: K032127(TRADITIONAL)
ATTN: DEBBIE IAMPIETRO PHONE NO : 508-435-9893
7 TIFFANY TRAIL SE DECISION MADE: 30-DEC-03
HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERSYO.BOND
HERAEUS KULZER, INC. 510(k) NO: K033629(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN PHONE NO : 574-299-6662
4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 22-DEC-03
SOUTH BEND, IN 46614-2517 510(k) STATEMENT
DEVICE: VENUS FLOW
HERAEUS KULZER, INC. 510(k) NO: K033665(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN PHONE NO : 574-299-6662
4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 30-DEC-03
SOUTH BEND, IN 46614 510(k) STATEMENT
DEVICE: STRYKER SPINE MAPS SYSTEM
HOWMEDICA OSTEONICS 510(k) NO: K032855(TRADITIONAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718
59 ROUTE 17 SE DECISION MADE: 10-DEC-03
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCORPIO LOW PROFILE TIBIAL TRAY
HOWMEDICA OSTEONICS CORP. 510(k) NO: K032829(TRADITIONAL)
ATTN: MARGARET F CROWE PHONE NO : 201-831-5580
59 ROUTE 17 SE DECISION MADE: 10-DEC-03
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF
HYGIA HEALTH SERVICES, INC. 510(k) NO: K032821(TRADITIONAL)
ATTN: TRACY W COMAS PHONE NO : 205-314-3920
434 INDUSTRIAL LN. SE DECISION MADE: 05-DEC-03
BIRMINGHAM, AL 35211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLC2000 CATHETER PATENCY DEVICE
ICU MEDICAL, INC. 510(k) NO: K021692(TRADITIONAL)
ATTN: ALISON D BURCAR PHONE NO : 949-366-2183
951 CALLE AMANECER SE DECISION MADE: 04-DEC-03
SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS)
IMAGING THERAPEUTICS, INC. 510(k) NO: K033242(TRADITIONAL)
ATTN: LYNDALL ERB PHONE NO : 650-286-4151
1720 SOUTH AMPHLETT BLVD. SE DECISION MADE: 31-DEC-03
SUITE 240 510(k) SUMMARY AVAILABLE FROM FDA
SAN MATEO, CA 94402
DEVICE: IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IG
IMMCO DIAGNOSTICS, INC. 510(k) NO: K032571(TRADITIONAL)
ATTN: KEVIN LAWSON PHONE NO : 716-691-0091
60 PINEVIEW DR. SE DECISION MADE: 24-DEC-03
BUFFALO, NY 14228 510(k) STATEMENT
DEVICE: IMMUNETECH TOTAL IGE SYSTEM
IMMUNETECH CORPORATION 510(k) NO: K032251(TRADITIONAL)
ATTN: VIVIANNE NOETZEL PHONE NO : 858-756-8483
P.O. BOX 9433 SE DECISION MADE: 19-DEC-03
17394 VIA DEL BRAVO 510(k) SUMMARY AVAILABLE FROM FDA
RANCHO SANTA FE, CA 92067
DEVICE: INSORB ABSORBABLE STAPLE, MODEL SP-B20
INCISIVE SURGICAL, INC. 510(k) NO: K033602(SPECIAL)
ATTN: JIM PETERSON PHONE NO : 952-591-2543
14405 21ST AVE N. SE DECISION MADE: 16-DEC-03
SUITE 130 510(k) SUMMARY AVAILABLE FROM FDA
PLYMOUTH, MN 55447
DEVICE: QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HI
INSTRUMENTATION LABORATORY CO. 510(k) NO: K032663(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 19-DEC-03
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO COATEST FACTOR VIII
INSTRUMENTATION LABORATORY CO. 510(k) NO: K033631(SPECIAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVENUE SE DECISION MADE: 15-DEC-03
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IXL DIABETES MANAGEMENT SYSTEM
INSULET CORP. 510(k) NO: K031373(TRADITIONAL)
ATTN: HOWARD HOLSTEIN PHONE NO : 202-637-5600
555 13TH ST., NW SE DECISION MADE: 18-DEC-03
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTOUR-FLEX VALVE AND SHUNT SYSTEM
INTEGRA NEUROSCIENCES IMPLANTS S.A510(k) NO: K033698(SPECIAL)
ATTN: JUDITH E O'GRADY PHONE NO : 609-936-2311
311 ENTERPRISE DRIVE SE DECISION MADE: 17-DEC-03
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHOENIX INFANT RADIANT WARMER, MODEL 100NWS
INTERNATIONAL HOSPITAL SUPPLY CO. 510(k) NO: K033040(ABBREVIATED)
ATTN: DAGMAR MASER PHONE NO : 31 20 4289591
AMSTEL 320-1 SE DECISION MADE: 17-DEC-03
AMSTERDAM, NETHERLANDS 1017AP 510(k) STATEMENT
DEVICE: INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS
INTRA-LOCK INTERNATIONAL 510(k) NO: K031322(ABBREVIATED)
ATTN: JEFFERY SAKOFF PHONE NO : 561-447-8282
1200 N. FEDERAL HWY SUITE#200 SE DECISION MADE: 23-DEC-03
BOCA RATON, FL 33432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSS
INTRALUMINAL THERAPEUTICS, INC. 510(k) NO: K033708(SPECIAL)
ATTN: PAMELA MISAJON PHONE NO : 760-918-1820
6354 CORTE DEL ABETO SE DECISION MADE: 11-DEC-03
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92009
DEVICE: RH-950
IOMED, INC. 510(k) NO: K033192(TRADITIONAL)
ATTN: CURTIS JENSEN PHONE NO : 801-975-1191
2441 SOUTH 3850 WEST, SUITE A SE DECISION MADE: 22-DEC-03
SALT LAKE CITY, UT 84120-9941 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHENOL RED STOCK SOLUTION
IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K032887(TRADITIONAL)
ATTN: WENDELL LEE PHONE NO : 800-437-5706
2511 DAIMLER ST. SE DECISION MADE: 19-DEC-03
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: NUCAMMA RX
IS2 RESEARCH, INC. 510(k) NO: K032779(TRADITIONAL)
ATTN: VICTOR WOODBURN PHONE NO : 613 228 8755
20 GURDWARA RD., UNITS 3-10 SE DECISION MADE: 17-DEC-03
OTTAWA, ONTARIO, CANADA K2E 8B3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLUEPHASE
IVOCLAR VIVADENT, INC. 510(k) NO: K033520(TRADITIONAL)
ATTN: DONNA MARIE HARTNETT PHONE NO : 716-691-2260
175 PINEVIEW DR. SE DECISION MADE: 05-DEC-03
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: JUSTWIN SCOOTER, JS-3013
JOY RIDE TECH CO., LTD. 510(k) NO: K032643(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO.58, FU-CHIUN ST SE DECISION MADE: 02-DEC-03
HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: JUSTWIN SCOOTER, JS-3014
JOY RIDE TECH CO., LTD. 510(k) NO: K032645(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO.58, FU-CHIUN ST SE DECISION MADE: 02-DEC-03
HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: KACEY INSULIN SYRINGE
KACEY, INC. 510(k) NO: K033166(TRADITIONAL)
ATTN: CHARLES F NEILSON, PHD PHONE NO : 803-328-0856
715 BUCKEYE TERRACE SE DECISION MADE: 12-DEC-03
ROCK HILL, SC 29732 510(k) STATEMENT
DEVICE: GEM INSET PATELLAR COMPONENT
KINAMED, INC. 510(k) NO: K032950(TRADITIONAL)
ATTN: VINEET SARIN PHONE NO : 805-384-2748
820 FLYNN RD. SE DECISION MADE: 19-DEC-03
CAMARILLO, CA 93012 510(k) STATEMENT
DEVICE: EPRICORD
KURARAY MEDICAL INC. 510(k) NO: K033267(TRADITIONAL)
ATTN: SATOSHI YAMAGUCHI PHONE NO : 212-986-2230
101 EAST 52ND STREET, 26TH FL. SE DECISION MADE: 22-DEC-03
NEW YORK, NY 10022 510(k) STATEMENT
DEVICE: SET GRI-FILL 2.0-1 WAY; 2.0-2 WAYS; LUER CONNECTION TUBE
LABORATORIOS GRIFOLS, S.A. 510(k) NO: K033682(TRADITIONAL)
ATTN: SEBASTIAN GASCON PHONE NO : 34 93 5710100
POL. LEVANTE C/CAN GUASCH, 2 SE DECISION MADE: 17-DEC-03
PARETS DEL VALLES, BARCELONA, SPAI510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GRI-BAG, GRI-BAG AP
LABORATORIOS GRIFOLS, S.A. 510(k) NO: K033916(TRADITIONAL)
ATTN: SEBASTIAN GASCON PHONE NO : 34 93 5710100
POL. LEVANTE C/CAN GUASCH, 2 SE DECISION MADE: 30-DEC-03
PARETS DEL VALLES, BARCELONA, SPAI510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HYDROPHILIC GUIDEWIRE
LAKE REGION MFG., INC. 510(k) NO: K033758(SPECIAL)
ATTN: KAREN MORTENSEN PHONE NO : 952-448-5111
340 LAKE HAZELTINE DR. SE DECISION MADE: 19-DEC-03
CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05
LEMAITRE VASCULAR, INC. 510(k) NO: K033159(TRADITIONAL)
ATTN: BRIAN K KEOGH PHONE NO : 781-221-2266
63 2ND AVENUE SE DECISION MADE: 19-DEC-03
BURLINGTON, MA 01803 510(k) STATEMENT
DEVICE: ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATAL
LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K033094(TRADITIONAL)
ATTN: CHENG-I LIN PHONE NO : 408-732-3856
687 NORTH PASTORIA AVE. SE DECISION MADE: 19-DEC-03
SUNNYVALE, CA 94085-2917 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIDENT RESECTION ABLATOR
LINVATEC CORP. 510(k) NO: K033748(SPECIAL)
ATTN: LAURA D KREJCI PHONE NO : 727-399-5234
11311 CONCEPT BLVD. SE DECISION MADE: 15-DEC-03
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOANCHOR WITH DISPOSABLE DRIVER
LINVATEC CORP. 510(k) NO: K033804(SPECIAL)
ATTN: LAURA D KREJCI PHONE NO : 727-399-5234
11311 CONCEPT BLVD. SE DECISION MADE: 31-DEC-03
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V
LIVING DATA TECHNOLOGIES CORPORATI510(k) NO: K033657(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 19-DEC-03
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANTAGE PADDLE
LIVINGSTON PRODUCTS, INC. 510(k) NO: K033202(ABBREVIATED)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 03-DEC-03
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELS
MASIMO CORP. 510(k) NO: K033298(SPECIAL)
ATTN: JAMES J CRONIN PHONE NO : 949-250-9688
2852 KELVIN AVE. SE DECISION MADE: 12-DEC-03
IRVINE, CA 92614-5826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRSANSDERM IONTO SYSTEM
MATTIOLI ENGINEERING CORP. 510(k) NO: K032968(TRADITIONAL)
ATTN: MELISSA MAHALL PHONE NO : 301-623-2500
11800 BALTIMORE AVENUE SE DECISION MADE: 02-DEC-03
SUITE 105 510(k) SUMMARY AVAILABLE FROM FDA
BELTSVILLE, MD 20705
DEVICE: SPECTRA QT: Q-SWITCHED ND: YAG LASER SYSTEM
MAX ENGINEERING LTD. 510(k) NO: K032735(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245
5 TIMBER LANE SE DECISION MADE: 03-DEC-03
NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMADERM
MEDAFOR, INC. 510(k) NO: K033666(TRADITIONAL)
ATTN: JENNIFER A MAY PHONE NO : 763-231-8263
2700 FREEWAY BLVD SE DECISION MADE: 17-DEC-03
SUITE 800 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55430
DEVICE: MEDICLUNG, RELEASE 1
MEDICSIGHT 510(k) NO: K033412(TRADITIONAL)
ATTN: CAROL MACDONALD PHONE NO : 44 207 5985751
46 BERKELEY SQUARE SE DECISION MADE: 30-DEC-03
LONDON, UNITED KINGDOM W 1J 5AT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETIC RESONANCE REGULATOR, MODEL MRR1
MEDIPHYSICS PAIN CENTERS OF AMERIC510(k) NO: K032928(TRADITIONAL)
ATTN: JAMES ROGERS PHONE NO : 949-215-0145
13 ORCHARD ROAD SE DECISION MADE: 19-DEC-03
UNIT 108 510(k) SUMMARY AVAILABLE FROM FDA
LAKE FOREST, CA 92630 THIRD PARTY REVIEW
DEVICE: UP-GRADE FOREHEAD THERMOMETER
MEDISIM LTD. 510(k) NO: K032362(TRADITIONAL)
ATTN: DALIA GIVONY PHONE NO : 972 267 99204
THE TECHNOLOGY PARK MANHAT SE DECISION MADE: 04-DEC-03
JERUSALEM, ISRAEL 96251 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTASCAN BLADDER SCANNER, MODEL PA00146
MEDIWATCH PLC 510(k) NO: K033906(TRADITIONAL)
ATTN: ANDREW HOPKINS PHONE NO : 00 44 1788547888
COSFORD LANE SE DECISION MADE: 24-DEC-03
RUGBY, WARWICKSHIRE, UNITED KINGDO510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (M
MEDTRONIC HEART VALVES 510(k) NO: K032810(TRADITIONAL)
ATTN: JULIE SHERMAN PHONE NO : 763-514-2876
8299 CENTRAL AVE., N.E. SE DECISION MADE: 05-DEC-03
M.S. P108 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55432-3576
DEVICE: MODIFICATION TO CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K033322(SPECIAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 15-DEC-03
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO EQUATION FIXATION SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K033495(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 03-DEC-03
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMUNOCARDSTAT HPSA
MERIDIAN BIOSCIENCE, INC. 510(k) NO: K032222(TRADITIONAL)
ATTN: SUSAN ROLIH PHONE NO : 513-271-3700
3471 RIVER HILLS DR. SE DECISION MADE: 05-DEC-03
CINCINNATI, OH 45244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 9 SECOND DIGITAL THERMOMETER, MODEL BT-S09
METATECH CO., LTD. 510(k) NO: K033082(TRADITIONAL)
ATTN: GUENTER GINSBERG PHONE NO : 239-948-2001
11820 RED HIBISCUS DR. SE DECISION MADE: 03-DEC-03
BONITA SPRINGS, FL 34135 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A1CNOW FOR HOME AND PROFESSIONAL USE
METRIKA, INC. 510(k) NO: K033847(SPECIAL)
ATTN: ERIKA AMMIRATI PHONE NO : 408-524-2255
510 OAKMEAD PKWY. SE DECISION MADE: 23-DEC-03
SUNNYVALE, CA 94085-4022 510(k) STATEMENT
DEVICE: MICROLAB SPIROMETER
MICRO DIRECT, INC. 510(k) NO: K031102(TRADITIONAL)
ATTN: DAVID R STASZAK PHONE NO : 207-786-7808
803 WEBSTER ST. SE DECISION MADE: 01-DEC-03
LEWISTON, ME 04240 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYDROCOIL EMBOLIC SYSTEM (HES)
MICROVENTION, INC. 510(k) NO: K033836(SPECIAL)
ATTN: VINCENT CUTARELLI PHONE NO : 949-768-1184
75 COLUMBIA SE DECISION MADE: 30-DEC-03
ALISO VIEJO, CA 92656-1408 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM
MISONIX, INC. 510(k) NO: K032690(TRADITIONAL)
ATTN: RONALD R MANNA PHONE NO : 631-694-9555
1938 NEW HIGHWAY SE DECISION MADE: 09-DEC-03
FARMINGDALE, NY 11735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR
MOOR INSTRUMENTS LTD. 510(k) NO: K032841(TRADITIONAL)
ATTN: DAVID BOGGETT PHONE NO : 44 129 735715
MILLWEY SE DECISION MADE: 10-DEC-03
AXMINSTER, DEVON, UNITED KINGDOM E510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR
NEWMEDICAL TECHNOLOGY, INC. 510(k) NO: K030485(TRADITIONAL)
ATTN: HAITHAM MATLOUB PHONE NO : 262-523-0521
N.14 W.23833 STONE RIDGE DR. SE DECISION MADE: 03-DEC-03
SUITE G100, MAIL BOX #1 510(k) SUMMARY AVAILABLE FROM FDA
WAUKESHA, WI 53188
DEVICE: NON-CONTACT TONOMETER, MODEL NT-4000
NIDEK, INC. 510(k) NO: K031733(TRADITIONAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900
21911 ERIE LN. SE DECISION MADE: 04-DEC-03
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERABIEN ZR
NORITAKE CO., INC. 510(k) NO: K031968(TRADITIONAL)
ATTN: IVAN J WASSERMAN PHONE NO : 202-342-8400
3050 K STREET, NW, STE 400 SE DECISION MADE: 22-DEC-03
WASHINGTON, DC 20007 510(k) STATEMENT
DEVICE: NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY
NOVELENS, INC. 510(k) NO: K032309(TRADITIONAL)
ATTN: RICHARD E LIPPMAN PHONE NO : 240-683-3738
15825 SHADY GROVE ROAD SE DECISION MADE: 04-DEC-03
SUITE 30 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20850
DEVICE: SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750
OPUS MEDICAL, INC. 510(k) NO: K033317(TRADITIONAL)
ATTN: LAURA N KASPEROWICZ PHONE NO : 949-234-0400
27127 CALLE ARROYO, SUITE 1924 SE DECISION MADE: 30-DEC-03
SAN JUAN CAPISTRANO, CA 92675 510(k) STATEMENT
DEVICE: VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL
ORTHOVITA, INC. 510(k) NO: K032288(TRADITIONAL)
ATTN: GINA M NAGVAJARA PHONE NO : 610-407-5251
45 GREAT VALLEY PKWY. SE DECISION MADE: 19-DEC-03
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT
ORTHOVITA, INC. 510(k) NO: K032812(TRADITIONAL)
ATTN: DAVID J MCILHENNY PHONE NO : 610-407-5211
45 GREAT VALLEY PKWY. SE DECISION MADE: 08-DEC-03
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIDA ALGORITHM REV. B
ORTIVUS AB 510(k) NO: K023414(TRADITIONAL)
ATTN: KENNETH EKLUND PHONE NO : 46 8 4464535
ENHAGSSLINGAN 5 SE DECISION MADE: 05-DEC-03
TABY, SWEDEN SE-18325 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Z-SERIES MODULAR TOTAL HIP SYSTEM
OSTEOIMPLANT TECHNOLOGY, INC. 510(k) NO: K032729(TRADITIONAL)
ATTN: SAM SON PHONE NO : 410-785-0700
11201 PEPPER RD. SE DECISION MADE: 03-DEC-03
HUNT VALLEY, MD 21031-1201 510(k) STATEMENT
DEVICE: TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA
PARALLAX MEDICAL, INC. 510(k) NO: K033230(SPECIAL)
ATTN: LINDA PAUL PHONE NO : 831-439-0130
940 DISC DR. SE DECISION MADE: 12-DEC-03
SCOTTS VALLEY, CA 95066-4544 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M2376A PHILIPS DEVICE LINK SYSTEM
PHILIPS MEDICAL SYSTEMS 510(k) NO: K033680(SPECIAL)
ATTN: HERBERT VAN DYK PHONE NO : 49 703 14631734
HEWLETT PACKARD STR. 2 SE DECISION MADE: 11-DEC-03
BOBLINGEN, GERMANY D71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLURA XPER FD20
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K033737(TRADITIONAL)
ATTN: LYNN HARMER PHONE NO : 425-487-7312
22100 BOTHELL EVERETT HIGHWAY SE DECISION MADE: 09-DEC-03
M.S. 415 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98021-8431 THIRD PARTY REVIEW
DEVICE: ALLEGRO IMAGING SYSTEM
PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K033782(TRADITIONAL)
ATTN: CHRISTOF LITTWITZ PHONE NO : 440-483-3585
595 MINER RD. SE DECISION MADE: 19-DEC-03
CLEVELAND, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L
PIE MEDICAL 510(k) NO: K033604(TRADITIONAL)
ATTN: COLLEEN DENSMORE PHONE NO : 317-849-1916
7992 CASTLEWAY DRIVE SE DECISION MADE: 15-DEC-03
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SLIM GLIDING NAIL SYSTEM
PLUS ORTHOPEDICS 510(k) NO: K033763(SPECIAL)
ATTN: NEIL DELANEY PHONE NO : 888-741-7587
6055 LUSK BLVD. SE DECISION MADE: 18-DEC-03
SAN DIEGO, CA 92121-2700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSF
PORTEX LTD. 510(k) NO: K033084(TRADITIONAL)
ATTN: STEVE OGILVIE PHONE NO : 00 440 1303260551
MILITARY ROAD SE DECISION MADE: 19-DEC-03
HYTHE, KENT, UNITED KINGDOM CT21 6510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFYRE VS AND SAFYRE T
PROMEDON 510(k) NO: K033691(SPECIAL)
ATTN: DEBBIE IAMPIETRO PHONE NO : 508-435-9893
7 TIFFANY TRAIL SE DECISION MADE: 19-DEC-03
HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT
PULPDENT CORPORATION 510(k) NO: K032953(TRADITIONAL)
ATTN: KENNETH J BERK PHONE NO : 617-926-6666
80 OAKLAND ST. SE DECISION MADE: 10-DEC-03
WATERTOWN, MA 02472 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM
R&B SURGICAL SOLUTIONS, LLC. 510(k) NO: K032752(TRADITIONAL)
ATTN: KAREN E WARDEN PHONE NO : 440-729-8457
8202 SHERMAN ROAD SE DECISION MADE: 03-DEC-03
CHESTERLAND, OH 44026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIANCY ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT ASSEMBLY
RADIANCY (ISRAEL) LTD. 510(k) NO: K032205(TRADITIONAL)
ATTN: JONATHAN S KAHN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 11-DEC-03
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANDOX RX DAYTONA
RANDOX LABORATORIES, LTD. 510(k) NO: K024014(TRADITIONAL)
ATTN: LYNNE HAMILTON PHONE NO : 44 28 94422413
55 DIAMOND RD. SE DECISION MADE: 04-DEC-03
CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT
DEVICE: RANDOX EVIDENCE
RANDOX LABORATORIES, LTD. 510(k) NO: K030360(TRADITIONAL)
ATTN: PAULINE ARMSTRONG PHONE NO : 44 28 94 422413
55 DIAMOND RD. SE DECISION MADE: 23-DEC-03
CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT
DEVICE: EVOLVE
RELIANCE ORTHODONTIC PRODUCTS, INC510(k) NO: K033551(SPECIAL)
ATTN: BENJAMIN LICHTENWALNER PHONE NO : 847-534-6146
1100 W. IRVING PARK RD. SE DECISION MADE: 16-DEC-03
SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIRAGE ACTIVA MASK
RESMED LTD. 510(k) NO: K032916(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238
14040 DANIELSON ST. SE DECISION MADE: 04-DEC-03
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEANER II ROTATIONAL THROMBECTOMY SYSTEM
REX MEDICAL 510(k) NO: K033793(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD. SE DECISION MADE: 16-DEC-03
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021 THIRD PARTY REVIEW
DEVICE: MESACUP-2 TEST JO-1, MODEL 10756
RHIGENE, INC. 510(k) NO: K033528(TRADITIONAL)
ATTN: NANCI DEXTER PHONE NO : 303-457-4345
12061 TEJON ST. SE DECISION MADE: 22-DEC-03
WESTMINSTER, CO 80234 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOGEL PAD
RICH-MAR CORP. 510(k) NO: K031018(TRADITIONAL)
ATTN: DAVID RICHARDS PHONE NO : 918-543-2222
15499 EAST 590TH RD. SE DECISION MADE: 08-DEC-03
P.O. BOX 879 510(k) STATEMENT
INOLA, OK 74036-0879
DEVICE: UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K033113(TRADITIONAL)
ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY. SE DECISION MADE: 23-DEC-03
VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UB 140
RIVERTRAIL MOBILITY 510(k) NO: K033827(TRADITIONAL)
ATTN: CLARK STANCIL PHONE NO : 501-745-6790
369 FACTORY ROAD SE DECISION MADE: 18-DEC-03
CLINTON, AR 72031 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS
ROCHE DIAGNOSTICS CORP. 510(k) NO: K033246(ABBREVIATED)
ATTN: KERWIN KAUFMAN PHONE NO : 317-521-7637
9115 HAGUE RD. SE DECISION MADE: 02-DEC-03
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
ROCHE DIAGNOSTICS CORP. 510(k) NO: K033306(ABBREVIATED)
ATTN: KERWIN KAUFMAN PHONE NO : 317-521-7637
9115 HAGUE RD. SE DECISION MADE: 15-DEC-03
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HDL-CHOLESTEROL PLUS 2ND GENERATION
ROCHE DIAGNOSTICS CORP. 510(k) NO: K033610(SPECIAL)
ATTN: SHERRI L COENEN PHONE NO : 317-521-3831
9115 HAGUE RD. SE DECISION MADE: 05-DEC-03
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FACTOR II (PROTHROMBIN) G20210A KIT
ROCHE DIAGNOSTICS CORP. 510(k) NO: K033612(TRADITIONAL)
ATTN: ROBERT A GREGG PHONE NO : 317-521-2386
9115 HAGUE RD. SE DECISION MADE: 18-DEC-03
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHTCYCLER INSTRUMENT VERSION 1.2
ROCHE DIAGNOSTICS CORP. 510(k) NO: K033734(TRADITIONAL)
ATTN: ROBERT A GREGG PHONE NO : 317-521-2386
9115 HAGUE RD. SE DECISION MADE: 17-DEC-03
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B&R DEVICE
RONVIG A/S 510(k) NO: K032925(TRADITIONAL)
ATTN: ANNETTE RAVN NIELSEN PHONE NO : 457 589 5711
GL. VEJLEVEJ 57-59 SE DECISION MADE: 22-DEC-03
DAUGAARD, DENMARK 8721 510(k) STATEMENT
DEVICE: FLUID FILLED TEETHERS
ROYAL KING INFANT PRODUCTS CO. LTD510(k) NO: K031094(TRADITIONAL)
ATTN: DALBIR SINGH KHURANA PHONE NO : 66 2 8924506
73/4 M00 1 KHAELIE SE DECISION MADE: 08-DEC-03
KRATHUMBAEN, SAMUTSAKOR, THAILAND 510(k) STATEMENT
DEVICE: INTERMITTENT URETHRAL CATHETERS
RUSCH INTL. 510(k) NO: K033023(TRADITIONAL)
ATTN: RICK LYKINS PHONE NO : 603-532-0204
50 PLANTATION DR. SE DECISION MADE: 23-DEC-03
JAFFERY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIROTEL, MODEL 29-1020
SDI DIAGNOSTICS, INC. 510(k) NO: K031643(TRADITIONAL)
ATTN: MICHAEL J BOYLE PHONE NO : 508-238-7033
10 HAMPDEN DR. SE DECISION MADE: 09-DEC-03
EASTON, MA 02375 510(k) STATEMENT
DEVICE: MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1
SECTRA-IMTEC AB 510(k) NO: K033712(SPECIAL)
ATTN: CARL ALLETTO PHONE NO : 214-262-4209
1600 MANCHESTER WAY SE DECISION MADE: 23-DEC-03
CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLARITY PET
SHARED P.E.T. IMAGING, LLC 510(k) NO: K032866(TRADITIONAL)
ATTN: RUSS PAGANO PHONE NO : 202-546-1262
710 A STREET, NE SE DECISION MADE: 12-DEC-03
WASHINGTON, DC 20002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHELHIGH NO-REACT BIOCUFF
SHELHIGH, INC. 510(k) NO: K032893(TRADITIONAL)
ATTN: SHLOMO GABBAY PHONE NO : 908-206-8906
650 LIBERTY AVE. SE DECISION MADE: 19-DEC-03
UNION, NJ 07083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400
SHIMADZU CORP. 510(k) NO: K033184(TRADITIONAL)
ATTN: TAKESHI OZAKI PHONE NO : 310-217-8855
20101 SOUTH VERMONT AVE. SE DECISION MADE: 09-DEC-03
TORRANCE, CA 90502-1328 510(k) STATEMENT
DEVICE: SIENET COSMOS
SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K033831(TRADITIONAL)
ATTN: EVA-MARIA REITER PHONE NO : 49 913 1842680
HENKESTRASSE 127 SE DECISION MADE: 19-DEC-03
ERLANGEN, GERMANY D-91052 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SYNGO PERFUSION-CT
SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K033832(TRADITIONAL)
ATTN: RUDIGER KORNER PHONE NO : 49 919 1189355
SIEMENSSTRASSE 1 SE DECISION MADE: 23-DEC-03
FORCHHEIM, GERMANY D 91301 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AIACT KIT
SIENCO, INC. 510(k) NO: K032952(TRADITIONAL)
ATTN: BARBARA DEBIASE PHONE NO : 303-420-1148
11485-A WEST 48TH AVE. SE DECISION MADE: 12-DEC-03
WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOTILITY VISUALIZATION SYSTEM
SIERRA SCIENTIFIC INSTRUMENTS, INC510(k) NO: K031169(TRADITIONAL)
ATTN: SEAN M CURRY PHONE NO : 858-675-8200
16787 BERNARDO CENTER DR. SE DECISION MADE: 12-DEC-03
SUITE A-1 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92128
DEVICE: SIROSON L AND SIROSONIC L ULTRASONIC SCALERS
SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K033640(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 12-DEC-03
NORTH ATTLEBORO, MA 02760-4153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHTWAVE INFRARED LAMPS LW10D AND LW30D
SKYTECH ENTERPRISES, INC. 510(k) NO: K024027(TRADITIONAL)
ATTN: LEWIS WARD PHONE NO : 303-530-3279
4655 KIRKWOOD COURT SE DECISION MADE: 03-DEC-03
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW IUR MORCELLATION SYSTEM
SMITH & NEPHEW, INC. 510(k) NO: K031787(TRADITIONAL)
ATTN: JANICE HASELTON PHONE NO : 978-749-1494
150 MINUTEMAN RD. SE DECISION MADE: 02-DEC-03
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AN
SMITH & NEPHEW, INC. 510(k) NO: K033669(SPECIAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487
1450 BROOKS RD. SE DECISION MADE: 10-DEC-03
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDISCOPE
SOMETECH CORPORATION 510(k) NO: K031436(TRADITIONAL)
ATTN: KI CHEOL HAN PHONE NO : 770-825-0100
6669 PEACHTREE INDUSTRIAL BLVD SE DECISION MADE: 19-DEC-03
SUITE J 510(k) SUMMARY AVAILABLE FROM FDA
NORCROSS, GA 30092
DEVICE: SPECTRA PULSED DIODE LASER, MODEL DR-1
SPECTRAGENICS, INC. 510(k) NO: K032846(TRADITIONAL)
ATTN: ROBERT E GROVE PHONE NO : 925-847-1762
7083 COMMERCE CIRCLE SE DECISION MADE: 11-DEC-03
SUITE 1 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANTON, CA 94588
DEVICE: REVOLUTION SPINAL FIXATION SYSTEM
SPINAL INNOVATIONS, INC. 510(k) NO: K032219(TRADITIONAL)
ATTN: JOE CLIFT PHONE NO : 901-373-8855
7850 STAGE HILLS BLVD. SE DECISION MADE: 19-DEC-03
SUITE 105 510(k) SUMMARY AVAILABLE FROM FDA
BARTLETT, TN 38133-4029
DEVICE: FIDJI SMALL CEMENT RESTRICTOR
SPINE NEXT SA 510(k) NO: K030767(TRADITIONAL)
ATTN: DIANE JOHNSON PHONE NO : 410-409-8276
104 GREENWOOD CREEK RD. SE DECISION MADE: 22-DEC-03
QUEENSTOWN, MD 21658 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIDJI LARGE CEMENT RESTRICTOR
SPINE NEXT SA 510(k) NO: K030871(TRADITIONAL)
ATTN: DIANE JOHNSON PHONE NO : 410-409-8276
104 GREENWOOD CREEK RD. SE DECISION MADE: 22-DEC-03
QUEENSTOWN, MD 21658 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE
SPIRE BIOMEDICAL, INC. 510(k) NO: K032061(TRADITIONAL)
ATTN: DONALD FICKETT PHONE NO : 781-275-6001
ONE PATRIOTS PARK SE DECISION MADE: 23-DEC-03
BEDFORD, MA 01730-2396 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOTUS
SRA DEVELOPMENTS, LTD. 510(k) NO: K032424(TRADITIONAL)
ATTN: T WHIT ATHEY PHONE NO : 301-570-0013
2305 GOLD MINE ROAD SE DECISION MADE: 16-DEC-03
BROOKEVILLE, MD 20833 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BOD
STRYKER CORP. 510(k) NO: K032943(TRADITIONAL)
ATTN: DANNIELLE WHEELER PHONE NO : 269-323-7700
4100 E. MILHAM AVE. SE DECISION MADE: 17-DEC-03
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER MINI-MENDER MENISCAL REPAIR SYSTEM
STRYKER ENDOSCOPY 510(k) NO: K032901(ABBREVIATED)
ATTN: MELISSA MURPHY PHONE NO : 408-754-2000
5900 OPTICAL CT. SE DECISION MADE: 02-DEC-03
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SISS INC. (D.B.A. MEDISISS) REPROCESSED ELECTROSURGICAL INSTRUME
SURGICAL INSTRUMENTS SERVICE AND S510(k) NO: K031869(TRADITIONAL)
ATTN: MARY ANN BARKER PHONE NO : 541-549-4164
723 CURTIS CT, SUITE A SE DECISION MADE: 24-DEC-03
SISTERS, OR 97759 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DEGALL II GALLBLADDER EXTRACTOR
SURGICON, INC. 510(k) NO: K033359(TRADITIONAL)
ATTN: CURTIS RAYMOND PHONE NO : 203-380-8771
400 LONG BEACH BLVD. SE DECISION MADE: 19-DEC-03
STRATFORD, CT 06615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISION-TECH YZ SLIT LAMP, MODEL 66
SUZHOU 66 VISION-TECH CO., LTD 510(k) NO: K033190(TRADITIONAL)
ATTN: ERIC LUO PHONE NO : 214-632-0636
6833 SAINT LAWRENCE STREET SE DECISION MADE: 04-DEC-03
PLANO, TX 75024 510(k) STATEMENT
DEVICE: POLARIS WR
SYNERON MEDICAL LTD. 510(k) NO: K031671(TRADITIONAL)
ATTN: AMIR WALDMAN PHONE NO : 972 4 9097424
POB 550 SE DECISION MADE: 01-DEC-03
YOKNEAM ELITE, ISRAEL 20692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO AURORA DS
SYNERON MEDICAL LTD. 510(k) NO: K033586(SPECIAL)
ATTN: AMIR WALDMAN PHONE NO : 972 67 404616
P.O. BOX 550 SE DECISION MADE: 10-DEC-03
INDUSTRIAL ZONE 510(k) SUMMARY AVAILABLE FROM FDA
YOKNEAM ILLIT, ISRAEL 20692
DEVICE: TAIWAN KING STRONG TC 03 MECHANICAL WHEELCHAIR
TAIWAN KING STRONG CO., LTD. 510(k) NO: K033031(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 02-DEC-03
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) STATEMENT
DEVICE: TAIWAN KING STRONG POWERED WHEELCHAIR, TP 01
TAIWAN KING STRONG CO., LTD. 510(k) NO: K033100(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 02-DEC-03
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VINYL EXAMINATION GLOVES, POWDERED
TANGSHAN TRANSOCEAN PLASTIC PRODUC510(k) NO: K033308(TRADITIONAL)
ATTN: IRIS YANG PHONE NO : 863 154 109985
NO. 188 BENHU ROAD SE DECISION MADE: 22-DEC-03
LUANNAN COUNTY 510(k) STATEMENT
TANGSHAN CITY; HEBEI, CHINA 063500
DEVICE: GLIDESHEATH
TERUMO CORP. 510(k) NO: K033681(SPECIAL)
ATTN: MARK UNTERREINER PHONE NO : 410-392-7213
125 BLUE BALL RD. SE DECISION MADE: 11-DEC-03
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROGREAT
TERUMO MEDICAL CORP. 510(k) NO: K033583(SPECIAL)
ATTN: MARK UNTERREINER PHONE NO : 410-392-7213
125 BLUE BALL RD. SE DECISION MADE: 12-DEC-03
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REDLINE ANTHRAX ALERT TEST
TETRACORE, INC 510(k) NO: K030370(TRADITIONAL)
ATTN: BEVERLY L MANGOLD PHONE NO : 301-258-7553
11 FIRSTFIELD RD. SE DECISION MADE: 09-DEC-03
SUITE C 510(k) SUMMARY AVAILABLE FROM FDA
GAITHERSBURG,, MD 20878
DEVICE: THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM
THAI NIPPON RUBBER INDUSTRY CO., L510(k) NO: K032909(ABBREVIATED)
ATTN: ELI J CARTER PHONE NO : 919-544-4098
1219 LITTLE CREEK RD. SE DECISION MADE: 16-DEC-03
DURHAM, NC 27713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C-GRAFT
THE CLINICIAN'S PREFERENCE LLC 510(k) NO: K033110(TRADITIONAL)
ATTN: CHARLES L MORIN PHONE NO : 415-957-0101
388 MARKET STREET, SUITE 500 SE DECISION MADE: 10-DEC-03
SAN FRANCISCO, CA 94111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIA
THERASENSE, INC. 510(k) NO: K031260(TRADITIONAL)
ATTN: DONNA K TEMPLEMAN PHONE NO : 510-239-2670
1360 SOUTH LOOP RD. SE DECISION MADE: 19-DEC-03
ALAMEDA, CA 94502-7000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM
TOPCON MEDICAL SYSTEMS, INC. 510(k) NO: K031831(TRADITIONAL)
ATTN: DONALD H WINFIELD PHONE NO : 201-261-9450
37 WEST CENTURY RD. SE DECISION MADE: 19-DEC-03
PARAMUS, NJ 07652 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEQUALIS SHOULDER FRACTURE SYSTEM
TORNIER S.A. 510(k) NO: K032679(SPECIAL)
ATTN: MIRELLE LEMERY PHONE NO : 003 347 6613898
ZIRST-161, RUE LAVOISIER SE DECISION MADE: 15-DEC-03
MONTBONNOT, FRANCE 38330 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGR
TRANSONIC SYSTEMS, INC. 510(k) NO: K033424(SPECIAL)
ATTN: MARK S ALSBERGE PHONE NO : 607-257-5300
34 DUTCH MILL RD. SE DECISION MADE: 11-DEC-03
WARREN RD. BUSINESS PARK 510(k) SUMMARY AVAILABLE FROM FDA
ITHACA, NY 14850
DEVICE: APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-4
TRANSPHOTON CORPORATION 510(k) NO: K033001(TRADITIONAL)
ATTN: SCOTT JENNINGS PHONE NO : 978-985-2532
37 ELECTRIC AVENUE SE DECISION MADE: 24-DEC-03
LUNENBURG, MA 01462 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S280
TUNG KENG ENTERPRISE CO., LTD. 510(k) NO: K033220(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 3 5208829
NO. 58 FU-CHIUN ST. SE DECISION MADE: 18-DEC-03
HSIN-CHU CITY, CHINA (TAIWAN) 427 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S200
TUNG KENG ENTERPRISE CO., LTD. 510(k) NO: K033240(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58 FU-CHIUN ST. SE DECISION MADE: 18-DEC-03
HSIN-CHU CITY, CHINA (TAIWAN) 427 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501
TYCO HEALTHCARE 510(k) NO: K032827(TRADITIONAL)
ATTN: GAIL CHRISTIE PHONE NO : 508-261-8440
15 HAMPSHIRE ST. SE DECISION MADE: 08-DEC-03
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TYTAN PROFESSIONAL /ECONOMY SERIES SPHYGMOMANOMETER, NO 710/NO 7
TYTAN MEDICAL CORP. 510(k) NO: K033025(TRADITIONAL)
ATTN: WILLIAM HSIEH PHONE NO : 886 289 883828
1-3F, NO. 2, 1 LANE, JUANG SE DECISION MADE: 10-DEC-03
SHING RD. SEC. 1, WU GU 248 510(k) STATEMENT
TAIPEI HSIEN, R.O.C., CHINA (TAIWAN) 248
DEVICE: ULTICARE DISPOSABLE SYRINGE 3 ML/CC
ULTIMED, INC. 510(k) NO: K033794(SPECIAL)
ATTN: ELLEN G REDDING PHONE NO : 360-466-1881
188 SUQUAMISH WAY SE DECISION MADE: 30-DEC-03
LACONNER, WA 98257 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERMAQUICK SE BONDING SYSTEM
ULTRADENT PRODUCTS, INC. 510(k) NO: K032626(TRADITIONAL)
ATTN: PETER ALLRED PHONE NO : 801-572-4200
505 WEST 10200 SOUTH SE DECISION MADE: 03-DEC-03
SOUTH JORDAN, UT 84095 510(k) STATEMENT
DEVICE: "LONG LOVE" CONDOM
UNIDUS CORP. 510(k) NO: K033541(ABBREVIATED)
ATTN: ELI J CARTER PHONE NO : 919-544-4098
1219 LITTLE CREEK RD. SE DECISION MADE: 23-DEC-03
DURHAM, NC 27713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE
UNITED STATES SURGICAL, A DIVISION510(k) NO: K032696(TRADITIONAL)
ATTN: CHESTER MCCOY PHONE NO : 203-492-5179
150 GLOVER AVE. SE DECISION MADE: 01-DEC-03
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEMINI III HYBRID TX/RX 4 CHANNEL HEAD COIL
USA INSTRUMENTS, INC. 510(k) NO: K033235(TRADITIONAL)
ATTN: CHRISTIE SHUMAKER PHONE NO : 330-562-1000
1515 DANNER DR. SE DECISION MADE: 17-DEC-03
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PELVIC ARRAY COIL
USA INSTRUMENTS, INC. 510(k) NO: K033753(SPECIAL)
ATTN: CHRISTIE SHUMAKER PHONE NO : 330-995-8572
1515 DANNER DR. SE DECISION MADE: 17-DEC-03
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED DISPOSABLE CUTTERS, STAPLERS AND APPLIERS
VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K032973(TRADITIONAL)
ATTN: MARK ALDANA PHONE NO : 806-787-0756
3706 76TH STREET SE DECISION MADE: 18-DEC-03
LUBBOCK, TX 79423 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMI REPROCESSED MULTIPLE CLIP APPLIERS
VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K032980(TRADITIONAL)
ATTN: MARK ALDANA PHONE NO : 806-787-0756
3706 76TH STREET SE DECISION MADE: 18-DEC-03
LUBBOCK, TX 79423 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS
VARIAN MEDICAL SYSTEMS 510(k) NO: K033371(TRADITIONAL)
ATTN: VY TRAN PHONE NO : 650-424-5731
3100 HANSEN WAY SE DECISION MADE: 24-DEC-03
M/S E-110 510(k) SUMMARY AVAILABLE FROM FDA
PALO ALTO, CA 94304-1129
DEVICE: ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K033339(TRADITIONAL)
ATTN: VY TRAN PHONE NO : 650-424-5731
3100 HANSEN WAY SE DECISION MADE: 30-DEC-03
PALO ALTO, CA 94304-1038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRILOGY RADIOTHERAPY DELIVERY SYSTEM
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K033343(TRADITIONAL)
ATTN: VY TRAN PHONE NO : 650-424-5731
3100 HANSEN WAY SE DECISION MADE: 23-DEC-03
PALO ALTO, CA 94304-1038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSER
VASCA, INC. 510(k) NO: K023023(TRADITIONAL)
ATTN: NAMA DODDI PHONE NO : 978-863-4400
3 HIGHWOOD DR. SE DECISION MADE: 04-DEC-03
TEWKSBURY, MA 01876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0
VASCULAR CONTROL SYSTEMS, INC 510(k) NO: K031812(TRADITIONAL)
ATTN: AL MEMMOLO PHONE NO : 949-488-8700
32236- E PASEO ADELANTO SE DECISION MADE: 12-DEC-03
SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER
VASCULAR SOLUTIONS, INC. 510(k) NO: K032763(TRADITIONAL)
ATTN: GREGORY SACHS PHONE NO : 763-656-4210
6464 SYCAMORE COURT NORTH SE DECISION MADE: 19-DEC-03
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGE
VASCULAR SOLUTIONS, INC. 510(k) NO: K033709(SPECIAL)
ATTN: GREGORY W SACHS PHONE NO : 763-656-4210
6464 SYCAMORE COURT SE DECISION MADE: 18-DEC-03
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERTELINK KOBRA SPINAL FIXATION SYSTEM
VERTELINK CORPORATION 510(k) NO: K032102(TRADITIONAL)
ATTN: GREG HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 12-DEC-03
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GORE BIOABSORBABLE MESH
W. L. GORE & ASSOCIATES, INC. 510(k) NO: K033671(TRADITIONAL)
ATTN: BRANDON HANSEN PHONE NO : 928-864-3784
3450 WEST KILTIE LN. SE DECISION MADE: 31-DEC-03
FLAGSTAFF, AZ 86002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POTENS +
WADA, INC. 510(k) NO: K033137(TRADITIONAL)
ATTN: GAIL RODRICK-HIGHBERG PHONE NO : 510-792-1527
35949 NICOLET CT. SE DECISION MADE: 08-DEC-03
FREMONT, CA 94536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LORENZ STERNAL CLOSURE SYSTEM
WALTER LORENZ SURGICAL, INC. 510(k) NO: K033740(SPECIAL)
ATTN: KIM REED PHONE NO : 904-741-4400
1520 TRADEPORT DR. SE DECISION MADE: 15-DEC-03
JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T-TECH DIGITAL, MODEL WL-22XXA SERIES
WELL-LIFE HEALTHCARE, INC. 510(k) NO: K033857(SPECIAL)
ATTN: JENNY HSIAH PHONE NO : 886 229 282112
6C01, NO.5, SEC.5, HSIN YI RD. SE DECISION MADE: 19-DEC-03
TAIPEI, CHINA (TAIWAN) 106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WILSON-COOK TRI-TOME SELECT PLUS
WILSON-COOK MEDICAL, INC. 510(k) NO: K033203(TRADITIONAL)
ATTN: MARGE WALLS-WALKER PHONE NO : 336-744-0157
4900 BETHANIA STATION RD. SE DECISION MADE: 19-DEC-03
WINSTON-SALEM, NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRACER METRO SMART WIRE GUIDE
WILSON-COOK MEDICAL, INC. 510(k) NO: K033754(SPECIAL)
ATTN: MARGE WALLS-WALKER PHONE NO : 336-744-0157
4900 BETHANIA STATION RD. SE DECISION MADE: 30-DEC-03
WINSTON-SALEM, NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIE-IN TRAPEZIUM
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K033529(SPECIAL)
ATTN: KATIE LOGEROT PHONE NO : 901-867-4476
5677 AIRLINE RD. SE DECISION MADE: 03-DEC-03
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROFEEL POWDER FREE, PLOYMER COATED POLYISOPRENE SURGICAL GLOVES
WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K032942(TRADITIONAL)
ATTN: TERENCE LIM PHONE NO : 60 3 87061486
LOT 1, JALAN 3, SE DECISION MADE: 17-DEC-03
KAWASAN PERUSAHAAN BANDAR BARU 510(k) SUMMARY AVAILABLE FROM FDA
SALAK TINGGI, SEPANG SELANGOR, MALAYSIA 43900
DEVICE: WU'S 3-WHEELED NEO SCOOTER, WT-T3D
WU'S TECH CO., LTD. 510(k) NO: K032488(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 02-DEC-03
HSIN-CHU CITY, CHINA (TAIWAN) ROC 510(k) STATEMENT
DEVICE: VPT METER
XILAS MEDICAL, INC. 510(k) NO: K030829(TRADITIONAL)
ATTN: RUBEN G ZAMORANO PHONE NO : 210-692-1114
12665 SILICON DR. SE DECISION MADE: 05-DEC-03
SAN ANTONIO, TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YA-MAN LASER 21
YA-MAN LTD 510(k) NO: K032944(TRADITIONAL)
ATTN: ROBERT T HANDREN PHONE NO : 352-314-8829
5818 PRINCESS CAROLINE PLACE SE DECISION MADE: 19-DEC-03
LEESBURG, FL 34748 510(k) STATEMENT
TOTAL 510(k)s THIS PERIOD 288
TOTAL WITH SUMMARIES 234
TOTAL WITH STATEMENTS 54
Updated January 5, 2004
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