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Medical Devices
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June 2009 510(k) Clearances
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD June 2009 DEVICE: XPRESSE INJECTION SYSTEM AESTHETIC SCIENCES CORPORATION 510(k) NO: K083583(TRADITIONAL)
ATTN: DENISE F GOTTFRIED PHONE NO : 650 322 9600 1455 ADAMS DRIVE SUITE 1110 SE DECISION MADE: 30-JUN-09 MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM GLOBUS MEDICAL INC. 510(k) NO: K090565(SPECIAL)
ATTN: KELLY J BAKER PHONE NO : 610 415 9000 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 30-JUN-09 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HANSO ACUPUNCTURE NEEDLE HANSOL MEDICAL CO. 510(k) NO: K090910(TRADITIONAL)
ATTN: PETER CHUN PHONE NO : 412 687 3976 300 ATWOOD ST. SE DECISION MADE: 30-JUN-09 PITTSBURGH PA 15213 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IDR ICRCO INC. 510(k) NO: K082450(TRADITIONAL) ATTN: THOMAS CHANEY PHONE NO : 310 921 9559 2580 WEST 237TH STREET SE DECISION MADE: 30-JUN-09 TORRANCE CA 90505 510(k) STATEMENT DEVICE: HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT) MICROVENTION, INC. 510(k) NO: K091641(SPECIAL)
ATTN: NAOMI GONG PHONE NO : 949 951 0592 75 COLUMBIA SUITE A SE DECISION MADE: 30-JUN-09 ALISO VIEJO CA 92656 1408 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEWDEAL COMPRESSION PLATE NEWDEAL SAS 510(k) NO: K091609(SPECIAL)
ATTN: JUDITH E O'GRADY PHONE NO : 609 936 2311 311 ENTERPRISE DR. SE DECISION MADE: 30-JUN-09 PLAINSBORO NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INERTIA PEDICLE SCREW SYSTEM NEXXT SPINE LLC 510(k) NO: K090984(TRADITIONAL)
ATTN: KAREN WARDEN PHONE NO : 440 729 8457 8202 SHERMAN ROAD SE DECISION MADE: 30-JUN-09 CHESTERLAND OH 44026 2141 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REGIONAL OXIMETER SYSTEM, MODEL 7600 NONIN MEDICAL, INC. 510(k) NO: K090807(TRADITIONAL)
ATTN: LORI M ROTH PHONE NO : 763 577 3093 13700 1ST AVE. NORTH SE DECISION MADE: 30-JUN-09 PLYMOUTH MN 55441 5443 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARCUS GRAFT FIXATION SYSTEM PARCUS MEDICAL, LLC 510(k) NO: K090923(TRADITIONAL)
ATTN: BARTON BRACY PHONE NO : 920 746 2972 839 SOUTH NEENAH AVE. SE DECISION MADE: 30-JUN-09 STURGEON BAY WI 54235 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION SHIMADZU CORP. 510(k) NO: K090268(ABBREVIATED) ATTN: DON KARLE PHONE NO : 310 217 8855 20101 SOUTH VERMONT AVE. SE DECISION MADE: 30-JUN-09 TORRANCE CA 90502 1328 510(k) STATEMENT DEVICE: RETINA CAMERA TRC-NW7SF MARK II TOPCON CORP. 510(k) NO: K090115(TRADITIONAL)
ATTN: TAKAO SUGAWARA PHONE NO : 813 355 82566 75-1 HASUNUMA-CHO ITABASHI-KU SE DECISION MADE: 30-JUN-09 TOKYO JA 174 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518 UROPLASTY, INC. 510(k) NO: K091391(TRADITIONAL)
ATTN: MICHAEL MORRELL PHONE NO : 952 426 6141 5420 FELTL RD. SE DECISION MADE: 30-JUN-09 MINNETONKA MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONTRA-ANGLE HANDPIECE KOMET OS30 W & H DENTALWERK BUERMOOS GMBH 510(k) NO: K090548(ABBREVIATED)
ATTN: JOHANN GEORG SCHARL PHONE NO : 43 627 46236297 IGNAZ GLASER STR. 53 SE DECISION MADE: 30-JUN-09 BUERMOOS AU A-5111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER NATURAL NAIL SYSTEM STAINLESS STEEL TIBIAL NAIL & STAINLESS PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEM ZIMMER, INC. 510(k) NO: K090596(TRADITIONAL)
ATTN: DANIEL J WILLIMAN PHONE NO : 574 371 8065 P.O. BOX 708 SE DECISION MADE: 30-JUN-09 WARSAW IN 46581 0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA. B. BRAUN MEDICAL, INC. 510(k) NO: K090884(TRADITIONAL)
ATTN: ANGELA J CARAVELLA PHONE NO : 610 596 2966 901 MARCON BLVD. SE DECISION MADE: 29-JUN-09 ALLENTOWN PA 18109 9341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL X-RAY IMAGING SYSTEM, MODEL: CXD-DR80D CHOONGWAE MEDICAL CORP. 510(k) NO: K083640(TRADITIONAL)
ATTN: CHARLIE MACK PHONE NO : 541 376 5063 77325 JOYCE WAY SE DECISION MADE: 29-JUN-09 ECHO OR 97826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS COOPER SURGICAL 510(k) NO: K091325(TRADITIONAL)
ATTN: THOMAS G WILLIAMS PHONE NO : 203 601 9825 95 CORPORATE DR. SE DECISION MADE: 29-JUN-09 TRUMBULL CT 06611 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERAMIC PEDATRIC PREFORMED CROWN EZ-PEDO INC 510(k) NO: K091362(TRADITIONAL)
ATTN: JEFFREY FISHER PHONE NO : 916 768 7592 2350 PROFESSIONAL DRIVE SUITE 200 SE DECISION MADE: 29-JUN-09 ROSEVILLE CA 95661 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOTONA XP ND: YAG LASER SYSTEM FAMILY, FOTONA XP, XP-2 FOCUS, FOTONA XP CHANGER,MODEL MOO1-14F, MOO1-14F, MOO1-14F/2, FOTONA D.D. 510(k) NO: K090126(TRADITIONAL)
ATTN: STOJAN TROST PHONE NO : 386 150 09100 STEGNE 7, SE DECISION MADE: 29-JUN-09 LJUBLJANA SI 1210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA 4100, 3100, 2100, 3131, 2121 GE HEALTHCARE 510(k) NO: K091658(SPECIAL)
ATTN: ALAN TOTAH PHONE NO : 262 544 3424 3000 N. GRANDVIEW BLVD SE DECISION MADE: 29-JUN-09 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYRIAN 1.4 INTRASENSE 510(k) NO: K091001(TRADITIONAL)
ATTN: FREDERIC BANEGAS PHONE NO : 33 467 130131 ROND POINT BENJAMIN FRANKLIN CS 39 SE DECISION MADE: 29-JUN-09 MONTPELLIER FR 34960 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER NEPHROS, INC. 510(k) NO: K090885(TRADITIONAL)
ATTN: VIKKI M O'CONNOR PHONE NO : 201 343 5202 41 GRAND AVE. SUITE 201 SE DECISION MADE: 29-JUN-09 RIVER EDGE NJ 07661 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MORCE POWER PLUS AND VARIOCARVE MORCELLATOR NOUVAG AG 510(k) NO: K080365(TRADITIONAL)
ATTN: ERICH FORSTER PHONE NO : 41 56 2019500 REUSSWEHRSTRASSE 1 SE DECISION MADE: 29-JUN-09 GEBENSTORF SZ CH-5412 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS NUCLETRON CORP. 510(k) NO: K091598(SPECIAL) ATTN: ELAINA COLBY PHONE NO : 443 545 2164 8671 ROBERT FULTON DRIVE SE DECISION MADE: 29-JUN-09 COLUMBIA MD 21046 510(k) STATEMENT DEVICE: HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L OLYMPUS WINTER & IBE GMBH 510(k) NO: K090980(TRADITIONAL)
ATTN: STACY A KUESNER PHONE NO : 484 896 5405 3500 CORPORATE PKWAY PO BOX 610 SE DECISION MADE: 29-JUN-09 CENTER VALLEY PA 18034 0610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MR CARDIAC FUNCTION ANALYSIS ZIOSOFT, INC. 510(k) NO: K091262(TRADITIONAL)
ATTN: RICHARD BALL PHONE NO : 650 413 1364 1000 BRIDGE PARKWAY, SUITE 100 SE DECISION MADE: 29-JUN-09 REDWOOD CITY CA 94065 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165 APOLLO ENDOSURGERY, INC. 510(k) NO: K090583(TRADITIONAL)
ATTN: GREG MATHISON PHONE NO : 512 328 9990 7000 BEE CAVES RD. SUITE 350 SE DECISION MADE: 26-JUN-09 AUSTIN TX 78746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHREX UNIVERS II SHOULDER PEGGED GLENOID ARTHREX, INC. 510(k) NO: K083435(SPECIAL)
ATTN: SALLY F OUST PHONE NO : 239 643 5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 26-JUN-09 NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERALAS MULTIWAVELENGTH 980/1470NM DIODE LASER BIOLITEC, INC. 510(k) NO: K090164(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202 637 5794 555 THIRTEENTH ST., NW SE DECISION MADE: 26-JUN-09 WASHINGTON DC 20004 1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730 BOSTON SCIENTIFIC CORPORATION 510(k) NO: K091510(SPECIAL)
ATTN: MARYBETH GAMBER PHONE NO : 508 683 4454 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 26-JUN-09 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWS DEPUY ORTHOPAEDICS, INC. 510(k) NO: K090877(TRADITIONAL)
ATTN: SUZANA OTANO PHONE NO : 305 269 6386 700 ORTHOPAEDIC DR. SE DECISION MADE: 26-JUN-09 WARSAW IN 46581 0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210 K-JUMP HEALTH CO., LTD. 510(k) NO: K083256(ABBREVIATED)
ATTN: JASON CHENG PHONE NO : 886 2 22991378 NO. 56, WU KUNG 5TH RD., WU KU IND SE DECISION MADE: 26-JUN-09 TAIPEI HSIEN TW 248 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFE SPINE FACET SCREW SPINAL SYSTEM LIFE SPINE 510(k) NO: K090865(TRADITIONAL)
ATTN: MURALI AUDIPUDY PHONE NO : 847 884 6117 2401 W. HASSELL RD. SUITE 1535 SE DECISION MADE: 26-JUN-09 HOFFMAN ESTATES IL 60169 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALICE PDX RESPIRONICS INC., SLEEP & HOME RES 510(k) NO: K090484(TRADITIONAL)
ATTN: ZITA A YURKO PHONE NO : 724 387 4120 1001 MURRY RIDGE LN. SE DECISION MADE: 26-JUN-09 MURRYSVILLE PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GUARDIAN 150 ELECTRODE SELECTIVE MED COMPONENTS, INC. 510(k) NO: K083756(TRADITIONAL)
ATTN: JAY MANSOUR PHONE NO : 678 908 8180 845 ARONSON LAKE COURT SE DECISION MADE: 26-JUN-09 ROSWELL GA 30075 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 SMITHS MEDICAL ASD, INC. 510(k) NO: K083119(ABBREVIATED)
ATTN: JOHN TULLETT PHONE NO : 44 130 3260551 BOUNDARY ROAD SE DECISION MADE: 26-JUN-09 HYTHE, KENT UK CT216JN 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES SOLTA MEDICAL, INC. 510(k) NO: K090580(TRADITIONAL)
ATTN: HEATHER MACFALLS PHONE NO : 510 780 4657 25881 INDUSTRIAL BLVD. SE DECISION MADE: 26-JUN-09 HAYWOOD CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOLOC ANKLE PLATING SYSTEM (APS) WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K091243(TRADITIONAL)
ATTN: SARAH HOLTGREWE PHONE NO : 901 867 4476 5677 AIRLINE RD. SE DECISION MADE: 26-JUN-09 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E. COLI PNA FISH ADVANDX, INC. 510(k) NO: K082068(TRADITIONAL) ATTN: HENRIK STENDER PHONE NO : 781 376 0009 10A ROESSLER ROAD SE DECISION MADE: 25-JUN-09 WOBURN MA 01801 510(k) STATEMENT DEVICE: LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK BIO-MEDICAL RESEARCH, LTD. 510(k) NO: K091317(SPECIAL)
ATTN: ANNE-MARIE KEENAN PHONE NO : 353 91 774300 BMR HOUSE PARKMORE BUSINESS PARK, SE DECISION MADE: 25-JUN-09 GALWAY EI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLLAWOUND WOUND DRESSING COLLAMATRIX CO., INC. 510(k) NO: K090894(TRADITIONAL)
ATTN: DENNIS J.N. SEAH PHONE NO : 886 2 77113299 26F, NO. 105, SECTION 2 DUNHUA SOU SE DECISION MADE: 25-JUN-09 TAIPEI TW 106 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM LDR SPINE USA 510(k) NO: K090507(SPECIAL)
ATTN: NOAH BARTSCH PHONE NO : 512 344 3319 4030 WEST BRAKER LANE SUITE 360 SE DECISION MADE: 25-JUN-09 AUSTIN TX 78759 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116 LUMINEX MOLECULAR DIAGNOSTICS, INC 510(k) NO: K091667(SPECIAL)
ATTN: GLORIA LEE PHONE NO : 416 593 4323 439 UNIVERSITY AVE. SE DECISION MADE: 25-JUN-09 TORONTO, ONTARIO CA M5G 1Y8 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET MAINE STANDARDS CO. 510(k) NO: K091225(TRADITIONAL)
ATTN: HOLLY CRESSMAN PHONE NO : 207 892 1300 765 ROOSEVELT TRAIL SE DECISION MADE: 25-JUN-09 WINDHAM ME 04062 5365 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285 MRI MANUFACTURING AND RESEARCH, IN 510(k) NO: K083685(TRADITIONAL)
ATTN: SUZANNE DEW PHONE NO : 520 882 7794 4700 SOUTH OVERLAND DR. SE DECISION MADE: 25-JUN-09 TUCSON AZ 85714 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CHARTIS CONSOLE PULMONX, INC. 510(k) NO: K083199(TRADITIONAL) ATTN: SUZON LOMMEL PHONE NO : 408 910 1222 1047 ELWELL COURT SE DECISION MADE: 25-JUN-09 PALO ALTO CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHARTIS CATHETER PULMONX, INC. 510(k) NO: K083883(TRADITIONAL)
ATTN: ROBERTA HINES PHONE NO : 425 481 8380 24125 85TH AVE SE SE DECISION MADE: 25-JUN-09 WOODINVILLE WA 98272 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN. VENTLAB CORP. 510(k) NO: K090840(TRADITIONAL) ATTN: JAMES A COCHIE PHONE NO : 336 753 5000 155 BOYCE DRIVE SE DECISION MADE: 25-JUN-09 MOCKSVILLE NC 27028 510(k) STATEMENT DEVICE: VERICORE ABUTMENT IN ZIRCONIA FOR IMPLANT SYSTEMS WHIP-MIX CORP. 510(k) NO: K090976(TRADITIONAL)
ATTN: ANGELA BLACKWELL PHONE NO : 704 450 9934 1317 KING STREET SE DECISION MADE: 25-JUN-09 ALEXANDRIA VA 22314 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULL BREATH SLEEP APPLIANCE LOWER (FBSL) BRYAN KEROPIAN DDS 510(k) NO: K091035(TRADITIONAL)
ATTN: BRYAN KEROPIAN PHONE NO : 818 881 7233 186663 VENTURA BLVD. SUITE 200 SE DECISION MADE: 24-JUN-09 TARZANA CA 91356 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD EPOCAL, INC. 510(k) NO: K090109(TRADITIONAL)
ATTN: ROY LAYER PHONE NO : 613 738 6192 2060 WALKLEY RD. SE DECISION MADE: 24-JUN-09 OTTAWA, ONTARIO CA K1G-3P5 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE LIGHTSPEED ACT FP16 GE MEDICAL SYSTEMS, INC. 510(k) NO: K091673(TRADITIONAL)
ATTN: ALLEN SCHUH PHONE NO : 414 721 3992 3000 N. GRANDVIEW BLVD. SE DECISION MADE: 24-JUN-09 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230 NORAS MRI PRODUCTS GMBH 510(k) NO: K091546(SPECIAL)
ATTN: ZAHED SEDIGHIANI PHONE NO : 499 312 992717 LEIBNITZSTRASSE 4 SE DECISION MADE: 24-JUN-09 HOECHBERG GM 97204 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TDS ABUTMENT FOR NOBEL BIOCARE REPLACE POU YU BIOTECHNOLOGY CO., LTD. 510(k) NO: K091026(TRADITIONAL)
ATTN: DANIEL TSAO PHONE NO : 886 4 7685660 NO. 6, FUGONG RD. SE DECISION MADE: 24-JUN-09 FUSING TOWNSHIP, CHANGHUA CTY T 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XIA 3 SPINAL SYSTEM, UNIPLANNER/REDUCTION SCREWS & VITALLIUM ROD STRYKER SPINE 510(k) NO: K091291(SPECIAL)
ATTN: CURTIS TRUESDALE PHONE NO : 201 760 8296 2 PEARL COURT SE DECISION MADE: 24-JUN-09 ALLENDALE NJ 07401 1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370 TRULY INSTRUMENT LIMITED 510(k) NO: K090564(ABBREVIATED)
ATTN: YANG JIAN-HAO PHONE NO : 860 660 3380070 TRULY INDUSTRIAL AREA SE DECISION MADE: 24-JUN-09 SHANWEI CITY, GUANGDONG CH 5166 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOPILOT NEXT GENERATION-UKA SOFTWARE, MODEL FS210 AESCULAP IMPLANT SYSTEM, INC. 510(k) NO: K090375(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610 984 9274 3773 CORPORATE PARKWAY SE DECISION MADE: 23-JUN-09 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHROCARE SYSTEM 15000 CONTOLLER, MODEL 72202149, ARTHROCARE ARTHROWANDS, MODEL 72202139,72202141, 72202143, 72202144 ARTHROCARE CORP. 510(k) NO: K090393(TRADITIONAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408 736 0224 680 VAQUEROS AVE. SE DECISION MADE: 23-JUN-09 SUNNYVALE CA 94085 3523 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CODMAN ISOCOOL BIPOLAR FORCEPS CODMAN & SHURTLEFF, INC. 510(k) NO: K083895(TRADITIONAL) ATTN: EMILY E VALERIO PHONE NO : 508 828 3038 325 PARAMOUNT DR. SE DECISION MADE: 23-JUN-09 RAYNHAM MA 02767 0350 510(k) STATEMENT DEVICE: FEMVUE(TM) CATHETER SYSTEM FEMASYS INC. 510(k) NO: K083690(TRADITIONAL)
ATTN: MARC FINCH PHONE NO : 770 500 3910 5000 RESEARCH COURT STE .100 SE DECISION MADE: 23-JUN-09 SUWANEE GA 30024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTELEPACS, MODEL VERSION 3.X.X INTELERAD MEDICAL SYSTEMS INCORPOR 510(k) NO: K083520(TRADITIONAL) ATTN: ANIBAL JODORCOVSKY PHONE NO : 514 931 6222 895 DE LA GAUCHETIERE ST WEST, SUI SE DECISION MADE: 23-JUN-09 MONTREAL, QB CA H3B 4G1 510(k) STATEMENT DEVICE: CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM LINVATEC CORP. 510(k) NO: K091549(SPECIAL)
ATTN: JOHN CUSACK PHONE NO : 727 399 5266 11311 CONCEPT BLVD. SE DECISION MADE: 23-JUN-09 LARGO FL 33773 4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISION TOOLS MILLENSYS 510(k) NO: K090668(TRADITIONAL) ATTN: CHRISTINE NICHOLS PHONE NO : 973 726 7679 24 SLABTOWN CREEK RD. SE DECISION MADE: 23-JUN-09 BLAIRSTOWN NJ 07825 510(k) STATEMENT DEVICE: BRILLIANCE DUAL ENERGY OPTION PHILIPS MEDICAL SYSTEMS(CLEVELAND) 510(k) NO: K090462(TRADITIONAL)
ATTN: MICHAEL A CHILBERT PHONE NO : 440 483 3284 595 MINER ROAD SE DECISION MADE: 23-JUN-09 CLEVELAND OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R RHYTHMLINK INTERNATIONAL, LLC 510(k) NO: K091055(TRADITIONAL)
ATTN: JAMES M MEWBORNE PHONE NO : 803 252 1222 1256 FIRST ST. SOUTH EXTENSION SE DECISION MADE: 23-JUN-09 COLUMBIA SC 29209 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252R RHYTHMLINK INTERNATIONAL, LLC 510(k) NO: K091056(TRADITIONAL)
ATTN: JAMES M MEWBORNE PHONE NO : 803 252 1222 1256 FIRST ST. SOUTH EXTENSION SE DECISION MADE: 23-JUN-09 COLUMBIA SC 29209 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VINYL POWDERED EXAMINATION GLOVE SHUN DA (XINGHUA) CO., LTD 510(k) NO: K091427(TRADITIONAL) ATTN: ZHANG YAN PHONE NO : 86 523 83102233 LOT20, TIAN SHUI HUA TING YUAN XIA SE DECISION MADE: 23-JUN-09 JIANGSU CH 225700 510(k) STATEMENT DEVICE: FORE V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244, FOREA V12 BLODO GLUCOSE MONITORING SYSTEM, MODEL TD-4247 TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K090404(SPECIAL) ATTN: YUHUA CHEN PHONE NO : 886 266 258188 6F, NO. 127, WUGONG 2ND RD WUGU TO SE DECISION MADE: 23-JUN-09 TAIPEI COUNTY TW 241 510(k) STATEMENT DEVICE: PORTALVISION ADVANCED IMAGING VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K091209(TRADITIONAL)
ATTN: VY TRAN PHONE NO : 650 424 5731 3100 HANSEN WAY M/S E-110 SE DECISION MADE: 23-JUN-09 PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JIAJIAN SELF-ADHESIVE ELECTRODE WUXI JIAJIAN MEDICAL INSTRUMENT CO 510(k) NO: K090198(TRADITIONAL)
ATTN: DORIS DONG PHONE NO : 86 510 88745788 QINGHONG RD., EHU TOWN XISHAN DIST SE DECISION MADE: 23-JUN-09 WUXI, JIANGSU CH 214116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXXENT FLEXISHIELD MINI XOFT, INC. 510(k) NO: K090417(TRADITIONAL)
ATTN: STEVE LIN PHONE NO : 408 419 2300 345 POTRERO AVE. SE DECISION MADE: 23-JUN-09 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIDAS CA 15-3 ASSAY BIOMERIEUX, INC. 510(k) NO: K080469(TRADITIONAL)
ATTN: NIKITA S MAPP PHONE NO : 314 731 7474 595 ANGLUM RD. SE DECISION MADE: 22-JUN-09 HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTENE CT, AOC CT, OSTEOTENE, CERETENE CEREMED INC. 510(k) NO: K091636(SPECIAL)
ATTN: TADEUSZ WELLISZ PHONE NO : 310 815 2125 3643 LENAWEE AVE. SE DECISION MADE: 22-JUN-09 LOS ANGELES CA 90016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERNER PROVISION WORKSTATION (VERSION 2.5) CERNER CORP. 510(k) NO: K091032(TRADITIONAL) ATTN: SHELLEY S LOOBY PHONE NO : 816 201 1368 2800 ROCKCREEK PKWY. SE DECISION MADE: 22-JUN-09 KANSAS CITY MO 64117 510(k) STATEMENT DEVICE: DEXIS SOFTWARE DEXIS LLC 510(k) NO: K090431(TRADITIONAL)
ATTN: CLAUDIA ORTIZ PHONE NO : 714 516 7484 1717 WEST COLLINS SE DECISION MADE: 22-JUN-09 ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANTI-WRINKLE LIGHT, MODEL 1302 AND PAIN THERAPY LIGHT, MODEL 1301 LED INTELLECTUAL PROPERTIES, LLC 510(k) NO: K083580(TRADITIONAL)
ATTN: ROBERT T WAGNER PHONE NO : 865 982 5552 1131 ANTHEM VIEW LANE SE DECISION MADE: 22-JUN-09 KNOXVILLE TN 37922 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR LINVATEC CORP. 510(k) NO: K090835(TRADITIONAL)
ATTN: JOY LOVETT PHONE NO : 727 399 5137 11311 CONCEPT BLVD. SE DECISION MADE: 22-JUN-09 LARGO FL 33773 4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROPLEX COIL SYSTEM-COSMOS MICROVENTION, INC. 510(k) NO: K090891(TRADITIONAL)
ATTN: NAOMI GONG PHONE NO : 949 461 3314 75 COLUMBIA SUITE A SE DECISION MADE: 22-JUN-09 ALISO VIEJO CA 92656 1408 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS POSSIS MEDICAL, INC. 510(k) NO: K091593(SPECIAL)
ATTN: DOUG ATKINS PHONE NO : 763 780 4555 9055 EVERGREEN BLVD., N.W. SE DECISION MADE: 22-JUN-09 MINNEAPOLIS MN 55433 8003 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAMBDA LIGHT CHAINS SENTINEL CH. SPA 510(k) NO: K083601(TRADITIONAL)
ATTN: YANGTSE PORTELLES PHONE NO : 39 023 4551456 VIA ROBERT KOCH, 2 SE DECISION MADE: 22-JUN-09 MILANO IT 20152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AS 1000 ULTRASOUND WOUND THERAPY SYSTEM AROBELLA MEDICAL, LLC 510(k) NO: K091038(TRADITIONAL)
ATTN: ELIAZ BABAEV PHONE NO : 952 345 6840 5929 BAKER ROAD SUITE 470 SE DECISION MADE: 19-JUN-09 MINNETONKA MN 55345 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVANT CARDIAC EVENT MONITORING SYSTEM; NUVANT MOBILE CARDIAC TELEMETRY SYSTEM CORVENTIS, INC. 510(k) NO: K090696(SPECIAL)
ATTN: MADHURI BHAT PHONE NO : 408 790 9306 2226 N. FIRST STREET SE DECISION MADE: 19-JUN-09 SAN JOSE CA 95131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM DENTIS CO. LTD. 510(k) NO: K082843(TRADITIONAL)
ATTN: JUNG BAE BANG PHONE NO : 562 404 8466 13340 E FIRESTONE BLVD SUITE J SE DECISION MADE: 19-JUN-09 SANTA FE SPRINGS CA 90670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM EDAN INSTRUMENTS, INC. 510(k) NO: K091680(TRADITIONAL)
ATTN: WILLIAM STERN PHONE NO : 914 376 5200 1 ODELL PLAZA SE DECISION MADE: 19-JUN-09 YONKERS NY 10701 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100 FLOWCARDIA, INC. 510(k) NO: K090621(TRADITIONAL)
ATTN: DUSTIN MICHAELS PHONE NO : 408 617 0352 745 N. PASTORIA AVE. SE DECISION MADE: 19-JUN-09 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMART-LOGIC AUTO DIGITAL UPPERARM BLOOD PRESSURE MONITOR, MODEL KP-7500, FULLY FUZZY AUTO DIGITAL UPPER ARM BLOOD PRESSU K-JUMP HEALTH CO., LTD. 510(k) NO: K083753(ABBREVIATED)
ATTN: JASON CHENG PHONE NO : 886 222 991378 NO. 56, WU KUNG 5TH RD., WU KU IND SE DECISION MADE: 19-JUN-09 TAIPEI HSIEN TW 248 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP MAKO SURGICAL CORP. 510(k) NO: K083644(TRADITIONAL)
ATTN: WILLIAM TAPIA PHONE NO : 954 927 2044 2555 DAVIE RD., SUITE 110 SE DECISION MADE: 19-JUN-09 FT. LAUDERDALE FL 33317 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00 MICRUS ENDOVASCULAR CORPORATION 510(k) NO: K091504(SPECIAL)
ATTN: TED RUPPEL PHONE NO : 408 433 1400 821 FOX LANE SE DECISION MADE: 19-JUN-09 SAN JOSE CA 95131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DSS STABILIZATION SYSTEM PARADIGM SPINE, LLC 510(k) NO: K090099(TRADITIONAL)
ATTN: JUSTIN EGGLETON PHONE NO : 202 552 5800 1331 H STREET NW 12TH FLOOR SE DECISION MADE: 19-JUN-09 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JETSTREAM G2 NXT SYSTEM, MODEL PV20300 PATHWAY MEDICAL TECHNOLOGIES, INC. 510(k) NO: K091509(SPECIAL)
ATTN: BRIT BAIRD PHONE NO : 425 636 4137 10801 120TH AVENUE NE SE DECISION MADE: 19-JUN-09 KIRKLAND WA 98033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYBER SURGICAL LASER FAMILY INCLUDING: CYBER TM, CYBER GREEN, CYBER GREEN TM QUANTA SYSTEM, S.P.A. 510(k) NO: K090962(TRADITIONAL)
ATTN: ISABELLA CARRER PHONE NO : 390 331 37679 VIA IV NOVEMBRE,116 SE DECISION MADE: 19-JUN-09 SOLBIATE OLONA(VA) IT 21058 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS ROCHE DIAGNOSTICS CORP. 510(k) NO: K082340(TRADITIONAL)
ATTN: KATHIE J GOODWIN PHONE NO : 317 521 3831 9115 HAGUE RD. SE DECISION MADE: 19-JUN-09 INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARI-LASE PLATINUM BRIGHT TIP LASER FIBER VASCULAR SOLUTIONS, INC. 510(k) NO: K091551(SPECIAL)
ATTN: LOUCINDA BJORKLUND PHONE NO : 763 656 4300 6464 SYCAMORE COURT SE DECISION MADE: 19-JUN-09 MINNEAPOLIS MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASCUTEK BRANCHED GELWEAVE VASCUTEK LTD. 510(k) NO: K090987(TRADITIONAL)
ATTN: KAREN KELSO PHONE NO : 141 812 5555 NEWMAINS AVE. SE DECISION MADE: 19-JUN-09 INCHINNAN, RENFREWSHIRE UK PA4 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAMLOG ABUTMENTS PS ALTATEC GMBH 510(k) NO: K090347(TRADITIONAL)
ATTN: LINDA SCHULZ PHONE NO : 858 792 1235 11234 EL CAMINO REAL SUITE 200 SE DECISION MADE: 18-JUN-09 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARAGON SURGICAL RF SYSTEM L2 INSTRUMENT ARAGON SURGICAL INC. 510(k) NO: K090306(TRADITIONAL)
ATTN: ALAN CURTIS PHONE NO : 650 543 3107 1810 EMBARCADERO ROAD, SUITE B SE DECISION MADE: 18-JUN-09 PALO ALTO CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 GRAM POSITIVE DAPTOMYCIN BIOMERIEUX, INC. 510(k) NO: K091126(TRADITIONAL)
ATTN: JOLYN TENLLADO PHONE NO : 314 731 8386 595 ANGLUM RD. SE DECISION MADE: 18-JUN-09 HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02 DATASCOPE CORP., CARDIAC ASSIST DI 510(k) NO: K091449(SPECIAL)
ATTN: DOLLY MISTRY PHONE NO : 973 244 6162 15 LAW DR. SE DECISION MADE: 18-JUN-09 FAIRFIELD NJ 07004 0011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NATURAZ SERIES, MODEL B16,B20, B42, B60, B98, B100 DENTAL SOLUTIONS, INC. 510(k) NO: K091096(TRADITIONAL)
ATTN: ANDREW PAENG PHONE NO : 310 858 2900 9301 WILSHIRE BLVD PH5 SE DECISION MADE: 18-JUN-09 BEVERLY CA 90210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DDI ULTRASONIC NEBULIZER SYSTEM DIAGNOSTIC DEVICES, INC. 510(k) NO: K090307(TRADITIONAL)
ATTN: E.J SMITH PHONE NO : 888 729 9674 1468 HARWELL AVE. SE DECISION MADE: 18-JUN-09 CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INOMAX DS (DELIVERY SYSTEM) INO THERAPEUTICS LLC 510(k) NO: K090958(SPECIAL)
ATTN: DAVID TRUEBLOOD PHONE NO : 908 608 3910 2902 DAIRY DR. SE DECISION MADE: 18-JUN-09 MADISON WI 53718 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KENS INTERNAL FIXATION SYSTEM KENS FINEMEDTECH SDN. BHD 510(k) NO: K090786(TRADITIONAL)
ATTN: LEOW K HOOI PHONE NO : 604 616 1356 19, FREE INDUSTRIAL ZONE PAHSE 4, SE DECISION MADE: 18-JUN-09 BAYAN LEPAS MY 11900 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM MCUBE TECHNOLOGY CO., LTD. 510(k) NO: K091518(TRADITIONAL)
ATTN: CHARLIE MACK PHONE NO : 931 937 8093 340 SHADY GROVE ROAD SE DECISION MADE: 18-JUN-09 FLINTVILLE TN 37335 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM N.I. MEDICAL, LTD. 510(k) NO: K080941(TRADITIONAL)
ATTN: JAMES COLLIE PHONE NO : 215 491 5245 414 MARYJOE WAY SE DECISION MADE: 18-JUN-09 WARRINGTON PA 18976 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MUCHECK V8 ONCOLOGY DATA SYSTEMS, INC. 510(k) NO: K091602(TRADITIONAL)
ATTN: VINCE RUMINER PHONE NO : 405 680 5222 1601 SW 89TH STREET BUILDING E-100 SE DECISION MADE: 18-JUN-09 OKLAHOMA CITY OK 73159 510(k) SUMMARY AVAILABLE FROM FDA sTHIRD PARTY REVIEW DEVICE: TREVAIR CHAIR PATMONT MOTOR WERKS, INC. 510(k) NO: K091478(TRADITIONAL)
ATTN: STEVEN J PATMONT PHONE NO : 775 782 0113 2220 MERIDIAN BLVD SE DECISION MADE: 18-JUN-09 MINDEN NV 89423 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS AVENT ANIMAL STAGE 2 AND 3 TEETHER, PHILIPS ELECTRONICS UK LIMITED 510(k) NO: K090167(TRADITIONAL) ATTN: MIRIAM SHARIF- MURRAY PHONE NO : 630 396 0510 10306 CHEVY CHASE DRIVE SE DECISION MADE: 18-JUN-09 HOUSTON TX 77042 510(k) STATEMENT DEVICE: ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190 ROCHE DIAGNOSTICS 510(k) NO: K090939(TRADITIONAL)
ATTN: MICHELLE L NEFF PHONE NO : 317 521 2000 9115 HAGUE ROAD SE DECISION MADE: 18-JUN-09 INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTIS ZEE / ZEEGOS WITH SW VC14 SIEMENS MEDICAL SOLUTIONS USA, INC 510(k) NO: K090745(TRADITIONAL)
ATTN: GARY JOHNSON PHONE NO : 610 448 1778 51 VALLEY STREAM PARKWAY, E-50 SE DECISION MADE: 18-JUN-09 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTEC ORTHODONTIC MINI SCREW SYNTEC SCIENTIFIC CORP. 510(k) NO: K090476(TRADITIONAL)
ATTN: SUSAN CHENG PHONE NO : 886 227 787396 3F1. 96 CHUNG HSIAO E. RD. SEC. 3 SE DECISION MADE: 18-JUN-09 TAIPEI TW 106 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K091492(SPECIAL)
ATTN: VY TRAN PHONE NO : 650 424 5731 3100 HANSEN WAY SE DECISION MADE: 18-JUN-09 PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PIGGYBACK WIRE CONVERTER VASCULAR SOLUTIONS, INC. 510(k) NO: K090977(TRADITIONAL)
ATTN: CHARMAINE SUTTON PHONE NO : 763 656 4200 6464 SYCAMORE COURT SE DECISION MADE: 18-JUN-09 MINNEAPOLIS MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K083305(TRADITIONAL)
ATTN: KIRK PENNER PHONE NO : 60 387 061486 LOT 1, JALAN 3, KAWASAN PERUSAHAAN SE DECISION MADE: 18-JUN-09 SALAK TINGGI, SEPANG SELANGOR M 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPEN MAGNETIC RESONANCE IMAGING SYSTEM, MODEL MPF3000-III XIOAO MDT TECHNOLOGY CO LTD 510(k) NO: K091669(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 21 64684973 UNDERWRITERS LABORATORIES, INC 333 SE DECISION MADE: 18-JUN-09 NORTHBROOK IL 60062 2096 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: STRATAPULSE TS AND STRATAPULSE ADVANCED MEDICAL PHOTONICS 510(k) NO: K090837(TRADITIONAL)
ATTN: SCOTT PORTER PHONE NO : 530 219 4089 1384 VIA COLONNA TERRANCE SE DECISION MADE: 17-JUN-09 DAVIS CA 95618 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MAGNUM MP FIXATION DEVICE ARTHROCARE CORP. 510(k) NO: K091503(SPECIAL)
ATTN: LAURA N KASPEROWICZ PHONE NO : 949 585 2406 15285 ALTON PARKWAY SUITE 200 SE DECISION MADE: 17-JUN-09 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CVS SILVER BANDAGES, WALGREENS SILVER BANDAGES, "XYZ" SILVER BANDAGES ASO LLC 510(k) NO: K082910(TRADITIONAL)
ATTN: JONATHAN WARD PHONE NO : 813 645 2855 962 ALLEGRO LN. SE DECISION MADE: 17-JUN-09 APOLLO BEACH FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COCHLEAR BAHA BP100 COCHLEAR BONE ANCHORED SYSTEMS AB 510(k) NO: K090720(TRADITIONAL)
ATTN: SEAN BUNDY PHONE NO : 800 523 5798 13059 E. PEAKVIEW AVE. SE DECISION MADE: 17-JUN-09 CENTENNIAL CO 80111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXICARE MEDICAL ENDOTRACHEAL TUBES FLEXICARE MEDICAL LTD. 510(k) NO: K091591(TRADITIONAL)
ATTN: DAVID MOYNHAM PHONE NO : 00 44 1443471593 CYNON VALLEY BUSINESS PARK MOUTAIN SE DECISION MADE: 17-JUN-09 MID GLAMORGAN UK CF45 4ER 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: EQUIA GC AMERICA, INC. 510(k) NO: K091106(TRADITIONAL) ATTN: MARK HEISS PHONE NO : 708 597 0900 3737 WEST 127TH ST. SE DECISION MADE: 17-JUN-09 ALSIP IL 60803 510(k) STATEMENT DEVICE: MULTILINK IMPLANT IVOCLAR VIVADENT, INC. 510(k) NO: K090704(TRADITIONAL) ATTN: DONNA M HARTNETT PHONE NO : 716 691 0010 175 PINEVIEW DR. SE DECISION MADE: 17-JUN-09 AMHERST NY 14228 510(k) STATEMENT DEVICE: LUCAS 2 JOLIFE AB 510(k) NO: K090422(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202 637 5813 555 13TH ST. NW SE DECISION MADE: 17-JUN-09 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM MAKO SURGICAL CORPORATION 510(k) NO: K090763(TRADITIONAL)
ATTN: WILLIAM F TAPIA PHONE NO : 954 927 2044 2555 DAVIE ROAD SE DECISION MADE: 17-JUN-09 FORT LAUDERDALE FL 33317 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50 MEDCOMP 510(k) NO: K091466(SPECIAL)
ATTN: SUSAN PILEGGI PHONE NO : 215 256 4201 1499 DELP DR. SE DECISION MADE: 17-JUN-09 HARLEYSVILLE PA 19438 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM PREMIER BRANDS OF AMERICA, INC. 510(k) NO: K090848(TRADITIONAL)
ATTN: MACK CAUTHEN PHONE NO : 718 325 3000 120 PEARL ST. SE DECISION MADE: 17-JUN-09 MOUNT VERNON NY 10550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COSTORSOL PRESERVATION SOLUTIONS, INC. 510(k) NO: K091245(TRADITIONAL)
ATTN: NEIL BURRIS PHONE NO : 720 323 1662 4250 GROVE STREET SE DECISION MADE: 17-JUN-09 DENVER CO 80211 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS) SYNTHES (USA) 510(k) NO: K090241(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610 719 6940 1301 GOSHEN PKWY. SE DECISION MADE: 17-JUN-09 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 4D INTEGRATED TREATMENT CONSOLE VARIAN MEDICAL SYSTEMS 510(k) NO: K091132(SPECIAL)
ATTN: VY TRAN PHONE NO : 650 424 5731 3100 HANSEN WAY M/S E-110 SE DECISION MADE: 17-JUN-09 PALO ALTO CA 94304 1129 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE VERMED, INC. 510(k) NO: K090180(ABBREVIATED)
ATTN: MARC FILLION PHONE NO : 802 463 9976 9 LOVELL DR. SE DECISION MADE: 17-JUN-09 BELLOWS FALLS VT 05101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMARIS GINGIVA OPAQUER VOCO GMBH 510(k) NO: K090843(TRADITIONAL)
ATTN: M. TH. PLAUMANN PHONE NO : 49 472 1719200 ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 17-JUN-09 CUXHAVEN GM D-27472 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUMED CLAVICLE SCREW SYSTEM ACUMED LLC 510(k) NO: K083144(TRADITIONAL)
ATTN: ALYSSA THOMAS PHONE NO : 503 627 9957 5885 NW CORNELIUS PASS RD. SE DECISION MADE: 16-JUN-09 HILLSBORO OR 97124 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REJUVENATE MONOLITHIC SIZE 4 HIP STEM HOWMEDICA OSTEONICS CORP 510(k) NO: K091161(TRADITIONAL)
ATTN: ESTELA CELI PHONE NO : 201 831 6461 325 CORPORATE DR. SE DECISION MADE: 16-JUN-09 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZVIEW (POLYMACON) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR I-SEE VISION TECHNOLOGY INC 510(k) NO: K082883(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928 773 9488 2904 N.BOLDT DRIVE SE DECISION MADE: 16-JUN-09 FLAGSTAFF AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR I-SEE VISION TECHNOLOGY INC 510(k) NO: K082879(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928 773 9488 2904 N.BOLDT DRIVE SE DECISION MADE: 16-JUN-09 FLAGSTAFF AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS I-SEE VISION TECHNOLOGY INC 510(k) NO: K082880(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928 773 9488 2904 N.BOLDT DRIVE SE DECISION MADE: 16-JUN-09 FLAGSTAFF AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STATIC VESSEL ANALYZER IMEDOS GMBH 510(k) NO: K082196(TRADITIONAL)
ATTN: HANS STROMEYER PHONE NO : 281 467 3424 317 SHORE BREEZE LANE SE DECISION MADE: 16-JUN-09 LEAGUE CITY TX 77573 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205 MEDTRONIC 510(k) NO: K090721(TRADITIONAL)
ATTN: PETER LIU PHONE NO : 763 514 9843 8200 CORAL SEA STREET NE SE DECISION MADE: 16-JUN-09 MINNEAPOLIS MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACTHYDERM MICROLAB AMERICAS INC 510(k) NO: K083016(TRADITIONAL)
ATTN: E J SMITH PHONE NO : 800 729 9674 1468 HARWELL AVE SE DECISION MADE: 16-JUN-09 CROFTON MD 2114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS PRIME HERBS CORPORATION 510(k) NO: K081720(TRADITIONAL)
ATTN: GENEVIEVE HSIA PHONE NO : 408 573 9889 1872 HARTOG DRIVE SE DECISION MADE: 16-JUN-09 SAN JOSE CA 95131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPRA 577.Y LASER QUANTEL MEDICAL 510(k) NO: K091581(TRADITIONAL)
ATTN: PATRICK QUERO PHONE NO : 334 737 45745 21 RUE NEWTON - ZONE DU BREZET SE DECISION MADE: 16-JUN-09 CLERMONT-FERRAND FR 63039 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST TURKLAB MEDICAL DEVICES INC 510(k) NO: K081150(TRADITIONAL)
ATTN: HILDA CIL PHONE NO : 902 323 736368 10040 SK. ATATURK ORGANIZE SANAYI SE DECISION MADE: 16-JUN-09 IZMIR, TU 35100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL RADIOGRAPHY CXDI-60C CANON INC. 510(k) NO: K091545(TRADITIONAL)
ATTN: SHEILA DRISCOLL PHONE NO : 516 328 5602 ONE CANON PLAZA SE DECISION MADE: 15-JUN-09 LAKE SUCCESS NY 11042 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES DEFIBTECH, LLC 510(k) NO: K081259(TRADITIONAL)
ATTN: ED HORTON PHONE NO : 203 453 6654 741 BOSTON POST ROAD,SUITE 201 SE DECISION MADE: 15-JUN-09 GUILFORD CT 06437 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HAMILTON-C2 HAMILTON BONADUZ AG 510(k) NO: K090468(TRADITIONAL)
ATTN: JOERG SCHNEIDER PHONE NO : 41 816 606010 VIA CRUSCH 8 SE DECISION MADE: 15-JUN-09 BONADUZ SZ 7402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS HITACHI MEDICAL SYSTEMS AMERICA, I 510(k) NO: K091103(TRADITIONAL)
ATTN: DOUG THISTLETHWAITE PHONE NO : 330 425 1313 1959 SUMMIT COMMERCE PARK SE DECISION MADE: 15-JUN-09 TWINSBURG OH 44087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVABONE DENTAL PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT NOVABONE PRODUCTS, LLC 510(k) NO: K091484(SPECIAL)
ATTN: DAVID M GALSSER PHONE NO : 386 462 7660 13709 PROGRESS BLVD., #33 SE DECISION MADE: 15-JUN-09 ALACHUA FL 32615 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONCENTRA SIMULATION 2.3 NUCLETRON CORPORATION 510(k) NO: K090706(TRADITIONAL)
ATTN: ELAINE COLBY PHONE NO : 443 545 2164 8671 ROBERT FULTON DR. SE DECISION MADE: 15-JUN-09 COLUMBIA MD 21046 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLAVICLE PLATING SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K090289(TRADITIONAL)
ATTN: DEREK LEWIS PHONE NO : 330 869 9562 1815 W. MARKET ST. SUITE 205 SE DECISION MADE: 15-JUN-09 AKRON OH 44313 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIRWAY BALLOON CATHETER INFLATION DEVICE ACCLARENT, INC. 510(k) NO: K090660(TRADITIONAL)
ATTN: KERI YEN PHONE NO : 650 687 5874 1525-B O'BRIEN DR. SE DECISION MADE: 12-JUN-09 MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01 ANULEX TECHNOLOGIES, INC 510(k) NO: K091432(SPECIAL)
ATTN: RACHEL KENNEDY PHONE NO : 952 224 4000 5600 ROWLAND ROAD, STE 280 SE DECISION MADE: 12-JUN-09 MINNETONKA MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLOCONTROL , MODEL 1028 COAXIA, INC. 510(k) NO: K090970(TRADITIONAL)
ATTN: SHARON D KVISTAD PHONE NO : 763 315 1809 10900 73RD AVE. N. SE DECISION MADE: 12-JUN-09 MAPLE GROVE MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER COOK, INC. 510(k) NO: K091527(SPECIAL)
ATTN: NATHAN SIMON PHONE NO : 812 339 2235 750 DANIELS WAY PO BX 489 SE DECISION MADE: 12-JUN-09 BLOOMINGTON IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CUSTOM COMFORT NIGHTGUARD VERSION 2 DENTEK ORAL CARE, INC. 510(k) NO: K091660(SPECIAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202 637 5813 555 THIRTEENTH STREET, NW SE DECISION MADE: 12-JUN-09 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS DEPUY ORTHOPAEDICS, INC. 510(k) NO: K090998(SPECIAL)
ATTN: RHONDA MYER PHONE NO : 574 371 4927 700 ORTHOPAEDIC DR. SE DECISION MADE: 12-JUN-09 WARSAW IN 46581 0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLUEPHASE 20I IVOCLAR VIVADENT, INC. 510(k) NO: K091020(TRADITIONAL)
ATTN: DONNA MARIE HARTNETT PHONE NO : 716 691 0010 175 PINEVIEW DR. SE DECISION MADE: 12-JUN-09 AMHERST NY 14228 510(k) STATEMENT DEVICE: KLS MARTIN ELECTROSURGICAL INSTRUMENTS KL MARTIN L.P. 510(k) NO: K082505(TRADITIONAL)
ATTN: TOM FAUCETT PHONE NO : 800 625 1557 11239 ST. JOHNS INDUST. PKY S. SE DECISION MADE: 12-JUN-09 JACKSONVILLE FL 32246 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFANT SLEEP BEANIE LIFE INNOVATIONS LLC 510(k) NO: K082367(TRADITIONAL)
ATTN: JANE SCOTT PHONE NO : 208 420 5059 P.O. BOX 148 SE DECISION MADE: 12-JUN-09 WELLINGTON CO 80549 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO70000 MAQUET CARDIOPULMONARY AG 510(k) NO: K090511(SPECIAL)
ATTN: FRANK MOEHRKE PHONE NO : 011 497 4789210 HECHINGER STRASSE 38 SE DECISION MADE: 12-JUN-09 HIRRLINGEN GM 72145 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VAKU-8 BLOOD COLLECTION NEEDLES MYCO MEDICAL SUPPLIES, INC. 510(k) NO: K090426(TRADITIONAL)
ATTN: SANJIV KUMAR PHONE NO : 919 460 2535 158 TOWERVIEW COURT SE DECISION MADE: 12-JUN-09 CARY NC 27513 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VEINWAVE, TC3000 NEWLANDS CLINICAL TRIALS LTD 510(k) NO: K083352(TRADITIONAL)
ATTN: WILLIAM GREENROSE PHONE NO : 603 369 3550 220 RIVER ROAD SE DECISION MADE: 12-JUN-09 CLAREMONT NH 03743 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATHOLASE FAMILY OF PINPOINTE AND PINPOINTE FOOTLASER ND: YAG LASERS PATHOLASE, INC 510(k) NO: K083616(TRADITIONAL)
ATTN: ANNE WORDEN PHONE NO : 925 895 1200 3637 BERNAL AVENUE SE DECISION MADE: 12-JUN-09 PLEASANTON CA 94566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E-MATRIX GRAFT BONE EXTENDER PIONEER SURGICAL TECHNOLOGY 510(k) NO: K083449(TRADITIONAL)
ATTN: JONATHAN GILBERT PHONE NO : 906 226 4812 375 RIVER PARK CIRCLE SE DECISION MADE: 12-JUN-09 MARQUETTE MI 49855 0627 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE SHANGHAI DOUBLE DOVE INDUSTRIAL CO 510(k) NO: K090929(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 216 4264467 SUITE 8D, NO.19, LANE 999 ZHONGSHA SE DECISION MADE: 12-JUN-09 SHANGHAI CH 200030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS SMITHS MEDICAL MD, INC. 510(k) NO: K091181(TRADITIONAL)
ATTN: JAMES CHAPMAN PHONE NO : 651 628 7611 1265 GREY FOX RD. SE DECISION MADE: 12-JUN-09 ST. PAUL MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II) TWIN STAR MEDICAL, INC. 510(k) NO: K090961(TRADITIONAL)
ATTN: GREGORY W SACHS PHONE NO : 612 840 1568 5116 BIRCH RD. SE DECISION MADE: 12-JUN-09 MINNETONKA MN 55345 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GOPHER GOLD CATHETER, MODEL 5620 VASCULAR SOLUTIONS, INC. 510(k) NO: K091345(SPECIAL)
ATTN: LOUCINDA BJORKLUND PHONE NO : 763 656 4300 6464 SYCAMORE COURT SE DECISION MADE: 12-JUN-09 MINNEAPOLIS MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAIXIN INTRAVASCULAR ADMINISTRATION SET ANHUI KANGDA MEDICAL PRODUCTS CO., 510(k) NO: K083687(TRADITIONAL)
ATTN: BIAN WEI QIANG PHONE NO : 86 215 0324423 1707 YINQIAO BLDG. 58 JINXIN RD., SE DECISION MADE: 11-JUN-09 PUDONG, SHANGHAI CH 201206 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D CONTEC MEDICAL SYSTEM CO., LTD. 510(k) NO: K090671(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 21 64264467 SUITE 8D , ZHONGXIN ZHONGSHAN MANS SE DECISION MADE: 11-JUN-09 ZHONG SHAN, SHANGHAI CH 20030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER INTERVENTIONAL SPINE, INC. 510(k) NO: K090767(SPECIAL)
ATTN: CAROL EMERSON PHONE NO : 949 472 0006 13700 ALTON PKWY., SUITE 160 SE DECISION MADE: 11-JUN-09 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO AVIE A1C TEST SYSTEM MEC DYNAMICS CORP 510(k) NO: K091400(SPECIAL)
ATTN: EMMANUEL MPOCK PHONE NO : 408 844 9279 2225 MARTIN AVE SUITE I SE DECISION MADE: 11-JUN-09 SANTA CLARA CA 95050 510(k) STATEMENT DEVICE: DISPOSABLE INFUSION SET SHAN DONG WEI GAO GROUP MEDICAL PO 510(k) NO: K090012(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 21 64264467 STE.8D, ZHONGXIN ZHONGSHAN MANSION SE DECISION MADE: 11-JUN-09 SHAN NAN ER RD., SHANGHAI CH 20 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES THD SPA 510(k) NO: K091490(SPECIAL)
ATTN: GUIDO BONAPACE PHONE NO : 393 355 378686 VIA BORGO SANTA CRISTINA 12 SE DECISION MADE: 11-JUN-09 IMOLA, BO IT 40026 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE BECTON DICKINSON & CO. 510(k) NO: K090680(SPECIAL)
ATTN: JOHN ROBERTS PHONE NO : 201 847 5473 1 BECTON DRIVE MC237 SE DECISION MADE: 10-JUN-09 FRANKLIN LAKES NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIPER 2 SYSTEM DEPUY SPINE, INC. 510(k) NO: K090648(SPECIAL)
ATTN: FRANK JURCZAK PHONE NO : 508 828 3288 325 PARAMOUNT DR. SE DECISION MADE: 10-JUN-09 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOLSKIN ELBIO CO., LTD 510(k) NO: K083008(ABBREVIATED)
ATTN: JAY MANSOUR PHONE NO : 678 908 8180 845 ARONSON LAKE COURT SE DECISION MADE: 10-JUN-09 ROSWELL GA 30075 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HABIB ENDOHPB EMCISION, LTD. 510(k) NO: K083292(TRADITIONAL)
ATTN: NAGY HABIB PHONE NO : 44 208 3832273 LIVER SURGERY, HAMMERSMITH HOSPITA SE DECISION MADE: 10-JUN-09 LONDON, UK UK W12 OHS 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS 28, CS 32, CS 211, CS 25L, CS 28L, CS 32L FRANKENMAN INTERNATIONAL LIMITED 510(k) NO: K090821(TRADITIONAL)
ATTN: JEAN ASQUITH PHONE NO : 512 327 9997 1705 S. CAPITAL OF HWY SUITE 500 SE DECISION MADE: 10-JUN-09 AUSTIN TX 78746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MI FLOW (GCUC-450) GC AMERICA, INC. 510(k) NO: K090747(TRADITIONAL)
ATTN: MARK HEISS PHONE NO : 708 897 4042 3737 WEST 127TH ST. SE DECISION MADE: 10-JUN-09 ALSIP IL 60803 510(k) STATEMENT DEVICE: MICROLIFE DIGITAL ELECTRONIC THERMOMETER, MODEL MT16K1 MICROLIFE INTELLECTUAL PROPERTY GM 510(k) NO: K091589(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516 482 9001 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 10-JUN-09 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHENZHEN MED-LINKET ADULT FINGER CLIP SPO2 SENSOR, SHENZHEN MED-LINKET ADULT SILICONE SOFT TIP SPO2 SENSOR SHENZHEN MED-LINK ELECTRONICS TECH 510(k) NO: K083010(TRADITIONAL)
ATTN: THOMAS KROENKE PHONE NO : 303 956 4232 PO BOX 3018 SE DECISION MADE: 10-JUN-09 NEDERLAND CO 80466 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM STANBIO LABORATORY 510(k) NO: K090093(SPECIAL)
ATTN: KIRK JOHNSON PHONE NO : 830 249 0772 1261 NORTH MAIN ST. SE DECISION MADE: 10-JUN-09 BOERNE TX 78006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THEKEN CORAL SPINAL SYSTEM THEKEN SPINE LLC 510(k) NO: K091266(SPECIAL)
ATTN: DALE DAVISON PHONE NO : 330 475 8600 1800 TRIPLETT BLVD. SE DECISION MADE: 10-JUN-09 AKRON OH 44306 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COR12+ VIASYS HEALTHCARE GMBH 510(k) NO: K091505(TRADITIONAL)
ATTN: THOMAS RUST PHONE NO : 499 314 972383 LEIBNIZSTRASSE 7 SE DECISION MADE: 10-JUN-09 HOECHBERG GM 97204 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TRIOS SYSTEM VIORA LTD. 510(k) NO: K090399(TRADITIONAL)
ATTN: JOSEF LUZON PHONE NO : 201 332 4100 30 MONTGOMERY STREET SUITE 660 SE DECISION MADE: 10-JUN-09 JERSEY CITY NJ 07302 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350 BOSTON SCIENTIFIC CORP. 510(k) NO: K091340(SPECIAL)
ATTN: MARYBETH GAMBER PHONE NO : 508 683 4454 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 09-JUN-09 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAXMORESPINE SPINAL SYSTEM HOOGLAND SPINE PRODUCTS GMBH 510(k) NO: K090132(ABBREVIATED)
ATTN: BORIS MIKLITZ PHONE NO : 490 892 15896020 ARABELLASTR 4 SE DECISION MADE: 09-JUN-09 MUENCHEN GM D-81925 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 MAX ENDOSCOPY INC. 510(k) NO: K083275(TRADITIONAL)
ATTN: MICHAEL WOLF PHONE NO : 330 425 7041 1410 HIGHLAND ROAD, SUITE 6 SE DECISION MADE: 09-JUN-09 MACEDONIA OH 44056 510(k) STATEMENT DEVICE: EPIPHANY INJECTION SYSTEM STAAR SURGICAL CO. 510(k) NO: K090161(TRADITIONAL)
ATTN: DIANA SMITH PHONE NO : 626 303 7902 1911 WALKER AVE. SE DECISION MADE: 09-JUN-09 MONROVIA CA 91016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC) CHURCH & DWIGHT CO., INC. 510(k) NO: K083716(TRADITIONAL)
ATTN: STEPHEN C KOLAKOWSKY PHONE NO : 609 279 7748 469 NORTH HARRISON STREET SE DECISION MADE: 08-JUN-09 PRINCETON NJ 08543 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OBI EUROTEKNIKA 510(k) NO: K083669(TRADITIONAL)
ATTN: EMMANUEL MONTINI PHONE NO : 514 397 6705 1100 RENE-LEVESQUE-BLVD WEST -25TH SE DECISION MADE: 08-JUN-09 MONTREAL, QUEBEC CA H3B 5C9 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO NORDICICE SOFTWARE NORDICIMAGINGLAB AS 510(k) NO: K090546(TRADITIONAL)
ATTN: CHANDANA G BHANDARI PHONE NO : 47 928 63160 MOLLENDALSVEIEN 65C SE DECISION MADE: 08-JUN-09 BERGEN NO 5009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVASIVE NEURO VISION SYSTEM NUVASIVE, INC. 510(k) NO: K090298(TRADITIONAL)
ATTN: HAN FAN PHONE NO : 858 909 3338 7475 LUSK BLVD SE DECISION MADE: 08-JUN-09 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SERAQUEST EBV EA-D IGG TEST QUEST INTL., INC. 510(k) NO: K091260(TRADITIONAL)
ATTN: DAVID J KIEFER PHONE NO : 305 592 6991 8127 N.W. 29TH STREET SE DECISION MADE: 08-JUN-09 DORAL FL 33122 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW RAIL SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K090926(TRADITIONAL)
ATTN: LAURA MEDLIN PHONE NO : 901 399 5349 1450 BROOKS RD. SE DECISION MADE: 08-JUN-09 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPIOX BUBBLE TRAP WITH X-COATING TERUMO CARDIOVASCULAR SYSTEMS 510(k) NO: K090698(TRADITIONAL)
ATTN: GARRY A COURTNEY PHONE NO : 800 283 7866 125 BLUE BALL ROAD SE DECISION MADE: 08-JUN-09 ELKTON MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROVOX VEGA, MODEL 8130-8135 ATOS MEDICAL AB 510(k) NO: K090455(TRADITIONAL)
ATTN: FERENC DAHNER PHONE NO : 464 151 9800 KRAFTGATAN 8 SE DECISION MADE: 05-JUN-09 HORBY SW SE-24222 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A6 LUER ACCESS DEVICE B. BRAUN MEDICAL, INC. 510(k) NO: K083723(TRADITIONAL)
ATTN: BONNIE J KINCAID, RAC PHONE NO : 610 596 2970 901 MARCON BLVD. SE DECISION MADE: 05-JUN-09 ALLENTOWN PA 18109 9341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO. 510(k) NO: K090971(TRADITIONAL)
ATTN: KATHRYN BABKA CARR PHONE NO : 410 316 4260 7 LOVETON CIR. SE DECISION MADE: 05-JUN-09 SPARKS MD 21152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIA STEERABLE DIAGNOSTIC CATHETER C.R. BARD, INC. 510(k) NO: K091370(SPECIAL)
ATTN: JULIA BRODERICK PHONE NO : 978 323 2220 55 TECHNOLOGY DRIVE SE DECISION MADE: 05-JUN-09 LOWELL MA 01851 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COVIDIEN EXTENDED TIP APPLICATOR CONFLUENT SURGICAL,INC 510(k) NO: K091315(SPECIAL)
ATTN: SEAN REYNOLDS PHONE NO : 781 839 1785 101A FIRST AVE. SE DECISION MADE: 05-JUN-09 WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RES-Q INFANT WEDGE AND SLING CR ENTERPRISES, LLC. 510(k) NO: K090284(TRADITIONAL)
ATTN: CRAIG A TROOP PHONE NO : 972 625 5177 4701 AUGUSTA DR. SE DECISION MADE: 05-JUN-09 FRISCO TX 75034 6839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR EMPI 510(k) NO: K090922(SPECIAL)
ATTN: SANDRA WALROD PHONE NO : 651 415 7344 CLEAR LAKE INDUSTRIAL PARK SE DECISION MADE: 05-JUN-09 CLEAR LAKE SD 57226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS FORESTADENT BERNHARD FORSTER GMBH 510(k) NO: K090933(TRADITIONAL)
ATTN: MICHAEL FIEB PHONE NO : 049 723 1459137 WESTLICHE KARL-FRIEDRICH STR 151 SE DECISION MADE: 05-JUN-09 PFORZHEIM, BADEN WURTEMBERG GM 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXALIS, SOFTWARE VERSION 1.15 GAMBRO, INC. 510(k) NO: K083158(TRADITIONAL)
ATTN: KAE MILLER PHONE NO : 303 542 5045 14143 DENVER WEST PARKWAY SE DECISION MADE: 05-JUN-09 LAKEWOOD CO 80401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3 GENCHEM, INC. 510(k) NO: K090283(ABBREVIATED)
ATTN: JAMES M HENNEMAN PHONE NO : 714 529 7125 510 WEST CENTRAL AVE., SUITE D SE DECISION MADE: 05-JUN-09 BREA CA 92821 510(k) STATEMENT DEVICE: KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100 KAI SENSORS, INC 510(k) NO: K090273(TRADITIONAL)
ATTN: AMY DROITCOUR PHONE NO : 808 447 2525 3465 WAIALAE AVENUE SUITE 370 SE DECISION MADE: 05-JUN-09 HONOLULU HI 96816 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XPI ANGLED ABUTMENTS KEYSTONE DENTAL, INC. 510(k) NO: K090397(TRADITIONAL)
ATTN: CAROLYN BITETTI PHONE NO : 781 328 3300 144 MIDDLESEX TURNPIKE SE DECISION MADE: 05-JUN-09 BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN LANG DENTAL MFG. CO., INC. 510(k) NO: K083195(TRADITIONAL)
ATTN: CHAH M SHEN PHONE NO : 847 215 6622 175 MESSNER DR. SE DECISION MADE: 05-JUN-09 WHEELING IL 60090 0969 510(k) STATEMENT DEVICE: PLANET 55, MODEL 100 LARSEN & TOUBRO LIMITED 510(k) NO: K090443(TRADITIONAL)
ATTN: YOLANDA SMITH PHONE NO : 888 729 9674 1468 HARWELL AVE. SE DECISION MADE: 05-JUN-09 CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STAR 55 MODEL 100 LARSEN & TOUBRO LIMITED 510(k) NO: K090172(TRADITIONAL)
ATTN: S.B. BHOSALE PHONE NO : 847 303 3902 1821 WALDEN OFFICE SQUARE SUITE 40 SE DECISION MADE: 05-JUN-09 SCHAUMBURG IL 60173 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM MEDAPPS, INC. 510(k) NO: K083862(TRADITIONAL)
ATTN: KENT DICKS PHONE NO : 480 305 6323 7975 NORTH HAYDEN ROAD SUITE A-200 SE DECISION MADE: 05-JUN-09 SCOTTSDALE AZ 85258 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORTOSS BONE AUGMENTATION MATERIAL ORTHOVITA, INC. 510(k) NO: K080108(TRADITIONAL)
ATTN: GINA M NAGVAJARA PHONE NO : 610 407 5251 45 GREAT VALLEY PKWY. SE DECISION MADE: 05-JUN-09 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE PEAK SURGICAL, INC. 510(k) NO: K083415(TRADITIONAL)
ATTN: LOIS NAKAYAMA PHONE NO : 650 331 3020 2464 EMBARCADERO WAY SE DECISION MADE: 05-JUN-09 PALO ALTO CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MP5 INTELLIVUE PATIENT MONITOR PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K091395(SPECIAL)
ATTN: ANDREAS SUCHI PHONE NO : 49 703 14631291 HEWLETT-PACKARD STR.2 SE DECISION MADE: 05-JUN-09 BOEBLINGEN GM D 71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RS- LB LOW BACK CONDUCTIVE GARMENT, MODEL RS-LBM, RS-LBL, RS-FBG FULL BACK CONDUCTIVE GARMENT , MODEL RS-FBG RS MEDICAL 510(k) NO: K090951(TRADITIONAL)
ATTN: TIMOTHY JOHNSON PHONE NO : 360 823 4940 14401 S.E. FIRST ST. SE DECISION MADE: 05-JUN-09 VANCOUVER WA 98684 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: VITREA ENDOVASCULAR STENT PLANNING SOFTWARE VITAL IMAGES, INC. 510(k) NO: K091498(TRADITIONAL)
ATTN: DARIN BUSCH PHONE NO : 952 487 9680 5850 OPUS PARKWAY, SUITE 300 SE DECISION MADE: 05-JUN-09 MINNETONKA MN 55343 4414 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: COLUMBUS REVISION KNEE SYSTEM AESCULAP IMPLANT SYSTEM, INC. 510(k) NO: K083772(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610 984 9274 3773 CORPORATE PARKWAY SE DECISION MADE: 04-JUN-09 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5903, KD-5909 ANDON HEALTH CO.,LTD 510(k) NO: K090772(SPECIAL)
ATTN: LIU YI PHONE NO : 862 260 5261618060 NO 31, CHANGJIANG ROAD NANKAI DIST SE DECISION MADE: 04-JUN-09 TIANJIN CH 300190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL, KD-5962 ANDON HEALTH CO.,LTD 510(k) NO: K090771(SPECIAL)
ATTN: LIU YI PHONE NO : 862 260 5261618060 NO 31, CHANGJIANG ROAD NANKAI DIST SE DECISION MADE: 04-JUN-09 TIANJIN CH 300190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7961 ANDON HEALTH CO.,LTD 510(k) NO: K090769(SPECIAL)
ATTN: LIU YI PHONE NO : 862 260 5261618060 NO 31, CHANGJIANG ROAD NANKAI DIST SE DECISION MADE: 04-JUN-09 TIANJIN CH 300190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5905 ANDON HEALTH CO.,LTD 510(k) NO: K090770(SPECIAL)
ATTN: LIU YI PHONE NO : 862 260 5261618060 NO 31, CHANGJIANG ROAD NANKAI DIST SE DECISION MADE: 04-JUN-09 TIANJIN CH 300190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD 5901, KD-7909, ANDON HEALTH CO.,LTD 510(k) NO: K090768(SPECIAL)
ATTN: LIU YI PHONE NO : 862 260 5261618060 NO 31, CHANGJIANG ROAD NANKAI DIST SE DECISION MADE: 04-JUN-09 TIANJIN CH 300190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C-QUR V -PATCH MESH ATRIUM MEDICAL CORP. 510(k) NO: K090909(SPECIAL)
ATTN: JOSEPH P DE PAOLO PHONE NO : 603 880 1433 5 WENTWORTH DR. SE DECISION MADE: 04-JUN-09 HUDSON NH 03051 510(k) STATEMENT DEVICE: R2 DIGITALNOW HD(DIGITALNOW HD) HOLOGIC, INC. 510(k) NO: K091368(TRADITIONAL)
ATTN: MICHAELA MAHL PHONE NO : 408 745 5148 35 CROSBY DR. SE DECISION MADE: 04-JUN-09 BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: REVOLUTION FULL CORE BIOPSY INRAD 510(k) NO: K090611(TRADITIONAL)
ATTN: MELISSA LALOMIA PHONE NO : 616 301 7800 4375 DONKER COURT S.E. SE DECISION MADE: 04-JUN-09 KENTWOOD MI 49512 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200) INTERMEDIC ARFRAN, S.A. 510(k) NO: K091323(SPECIAL)
ATTN: ANNE WORDEN PHONE NO : 925 895 1200 3637 BERNAL AVE. SE DECISION MADE: 04-JUN-09 PLEASANTON CA 94566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPEEDCEM IVOCLAR VIVADENT, INC. 510(k) NO: K091019(TRADITIONAL)
ATTN: DONNA MARIE HARTNETT PHONE NO : 716 691 0010 175 PINEVIEW DR. SE DECISION MADE: 04-JUN-09 AMHERST NY 14228 510(k) STATEMENT DEVICE: THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL, SACRAL PLATE, MODEL 1208-41FXXS K2M, INC. 510(k) NO: K091253(SPECIAL)
ATTN: RICHARD W WOODS PHONE NO : 703 777 3155 751 MILLER DR.,S.E., SUITE F1 SE DECISION MADE: 04-JUN-09 LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLOW CONTROLLER ODYSSEY MEDICAL, INC. 510(k) NO: K090938(TRADITIONAL)
ATTN: TERRY R GREEN PHONE NO : 901 383 7777 2975 BROTHER BLVD SE DECISION MADE: 04-JUN-09 BARTLETT TN 38133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S OSCOR INC. 510(k) NO: K090114(SPECIAL)
ATTN: MILA DOSKOCIL PHONE NO : 727 937 2511 3816 DE SOTO BLVD. SE DECISION MADE: 04-JUN-09 PALM HARBOR FL 34683 510(k) STATEMENT DEVICE: OPTION VENA CAVA FILTER REX MEDICAL 510(k) NO: K081410(TRADITIONAL)
ATTN: LEO BASTA PHONE NO : 508 351 8632 386 W. MAIN STREET SUITE 7 SE DECISION MADE: 04-JUN-09 NORTHBOROUGH MA 01532 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW, INC. VLP FOOT PLATING, SCREW SYSTEM AND ACCESSORIES SMITH & NEPHEW, INC. 510(k) NO: K090675(TRADITIONAL)
ATTN: JAHANVI AGNIHOTRI PHONE NO : 901 399 6130 1450 BROOKS RD. SE DECISION MADE: 04-JUN-09 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSITITRE YEASTONE SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K090968(TRADITIONAL)
ATTN: CYNTHIA KNAPP PHONE NO : 216 351 8735 982 KEYNOTE CIRCLE SUITE 6 SE DECISION MADE: 04-JUN-09 CLEVELAND OH 44131 510(k) STATEMENT DEVICE: EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMS TYSON BIORESEARCH, INC. 510(k) NO: K090629(SPECIAL)
ATTN: WEN-HAI TSAI PHONE NO : 886 37 585988 5F, #22, KE E. ROAD, III SCIENCE-B SE DECISION MADE: 04-JUN-09 CHUN-NAN, MIAO-LI COUNTY TW 350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPUS SPEEDLOCK KNOTLESS FIXATION DEVICE ARTHROCARE CORP. 510(k) NO: K090615(TRADITIONAL)
ATTN: LAURA N KASPEROWICZ PHONE NO : 949 585 2406 680 VAQUEROS AVE. SE DECISION MADE: 03-JUN-09 SUNNYVALE CA 94085 3523 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI BIO-RAD LABORATORIES, INC. 510(k) NO: K090737(TRADITIONAL)
ATTN: JOLENE BARTILSON PHONE NO : 510 741 6114 4000 ALFRED NOBEL DR SE DECISION MADE: 03-JUN-09 HERCULES CA 94547 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SE-601 SERIES ELECTROCARDIOGRAPH EDAN INSTRUMENTS, INC. 510(k) NO: K090367(TRADITIONAL)
ATTN: WILLIAM STERN PHONE NO : 914 376 5200 1 ODELL PLAZA SE DECISION MADE: 03-JUN-09 YONKERS NY 10701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERTAN CHS LIMITED COLLAPSE SET SCREW SMITH & NEPHEW, INC. 510(k) NO: K090656(TRADITIONAL)
ATTN: SHEREEN MYERS PHONE NO : 901 399 6325 1450 BROOKS RD. SE DECISION MADE: 03-JUN-09 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL SMITHS MEDICAL ASD, INC. 510(k) NO: K083336(TRADITIONAL)
ATTN: CHRISTINE LLOYD PHONE NO : 781 878 8011 160 WEYMOUTH ST. SE DECISION MADE: 03-JUN-09 ROCKLAND MA 02370 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXLINK OCT SYSTEM, MODEL 7000 SERIES ABBOTT SPINE, INC. 510(k) NO: K090060(TRADITIONAL)
ATTN: DAVID PADGETT PHONE NO : 512 918 2700 5301 RIATA PARK CT., BLDG F SE DECISION MADE: 02-JUN-09 AUSTIN TX 78727 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PENTA LEAD KITS, MODELS: 3227-3234 ADVANCED NEUROMODULATION SYSTEMS 510(k) NO: K090907(TRADITIONAL)
ATTN: AMY CLENDENING PHONE NO : 972 309 8553 6901 PRESTON RD. SE DECISION MADE: 02-JUN-09 PLANO TX 75024 510(k) STATEMENT DEVICE: PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K090934(SPECIAL)
ATTN: SARAH MEYER PHONE NO : 952 930 6431 10700 BREN RD., WEST SE DECISION MADE: 02-JUN-09 MINNETONKA MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO. 510(k) NO: K090824(TRADITIONAL)
ATTN: SABA MODJARRAD PHONE NO : 410 316 4685 7 LOVETON CIR. SE DECISION MADE: 02-JUN-09 SPARKS MD 21152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CODMAN HAKIM MICRO II VALVE CODMAN & SHURTLEFF, INC. 510(k) NO: K091346(SPECIAL)
ATTN: SHARON MCDERMOTT PHONE NO : 508 880 8349 325 PARAMOUNT DR. SE DECISION MADE: 02-JUN-09 RAYNHAM MA 02767 0350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS INSTRUMENTATION LABORATORY CO. 510(k) NO: K090209(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781 861 4467 113 HARTWELL AVE. SE DECISION MADE: 02-JUN-09 LEXINGTON MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASTERGRAFT STRIP MEDTRONIC SOFAMOR DANEK 510(k) NO: K082166(TRADITIONAL)
ATTN: MICHELLE OBENAUER PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 02-JUN-09 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASY ON-PC SPIROMETER NDD MEDIZITECHNIK AG 510(k) NO: K090034(TRADITIONAL)
ATTN: JERRY MASIELLO PHONE NO : 877 904 0090 TWO DUNDEE PARK SE DECISION MADE: 02-JUN-09 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION) NOBEL BIOCARE AB 510(k) NO: K090630(TRADITIONAL)
ATTN: HERBERT CRANE PHONE NO : 714 282 4800 22715 SAVI RANCH PARKWAY SE DECISION MADE: 02-JUN-09 YORBA LINDA CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER OCULUS INNOVATIVE SCIENCES, INC. 510(k) NO: K090206(TRADITIONAL)
ATTN: ANTOINETTE DOUGLAS PHONE NO : 707 283 0550 1135 N. MC DOWELL BLVD SE DECISION MADE: 02-JUN-09 PETALUMA CA 94954 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I-MAX TOUCH OWANDY 510(k) NO: K083057(TRADITIONAL)
ATTN: CLAUDE D BERTHOIN PHONE NO : 386 672 0450 110 E. GRANADA BLVD. SUITE 207 SE DECISION MADE: 02-JUN-09 ORMOND BEACH FL 32176 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BACKSTOP AND BACKSTOP INJECTOR PLUROMED, INC. 510(k) NO: K090430(TRADITIONAL)
ATTN: JAMES WILKIE PHONE NO : 478 932 0574 25-H OLYMPIA AVENUE SE DECISION MADE: 02-JUN-09 WOBURN MA 01801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEGAPULSE LASER SYSTEM AND FIBERS RICHARD WOLF MEDICAL INSTRUMENTS C 510(k) NO: K090776(TRADITIONAL)
ATTN: RON HASELHORST PHONE NO : 847 913 1113 353 CORPORATE WOODS PKWY. SE DECISION MADE: 02-JUN-09 VERNON HILLS IL 60061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: X-RAY, TOMOGRAPHY, COMPUTED, DENTAL SUNI MEDICAL IMAGING, INC. 510(k) NO: K083917(TRADITIONAL)
ATTN: AL BETTENCOURT PHONE NO : 408 227 6698 6840 VIA DEL ORO SE DECISION MADE: 02-JUN-09 SAN JOSE CA 95119 1379 510(k) STATEMENT DEVICE: COMPEX REHAB CHATTANOOGA GROUP 510(k) NO: K090632(TRADITIONAL)
ATTN: NORA C.R. YORK PHONE NO : 760 734 3122 1430 DECISION STREET SE DECISION MADE: 01-JUN-09 VISTA CA 92081 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATHWAY AVID CUSTOM SPINE, INC. 510(k) NO: K090566(TRADITIONAL)
ATTN: SAAD ATTIYAH PHONE NO : 973 265 5036 1140 PARSIPPANY BLVD. SUITE 201 SE DECISION MADE: 01-JUN-09 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM EMINENT SPINE 510(k) NO: K090415(TRADITIONAL)
ATTN: DAVE FREEHILL PHONE NO : 512 259 9002 16001 RONALD REAGAN BLVD. SE DECISION MADE: 01-JUN-09 LEANDER TX 78641 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G ETHICON ENDO-SURGERY, INC. 510(k) NO: K091322(TRADITIONAL)
ATTN: ASIFA VONHOF PHONE NO : 513 337 3118 4545 CREEK RD. SE DECISION MADE: 01-JUN-09 CINCINNATI OH 45242 2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES (PINK, GREEN, ORANGE,WHITE). GX CORPORATION SDN BHD 510(k) NO: K090412(TRADITIONAL)
ATTN: FOO KHON PU PHONE NO : 603 329 11600 LOT 6487, BATU 5 3/4, SEMENTA JALA SE DECISION MADE: 01-JUN-09 KLANG MY 42100 510(k) STATEMENT DEVICE: POWDER FREE NITRILE EXAMINATION GLOVE, GREEN TEA SCENTED, GREEN GX CORPORATION SDN BHD 510(k) NO: K091151(TRADITIONAL)
ATTN: FOO K PU PHONE NO : 603 329 11600 LOT 6487, BATU 5 3/4, SEMENTA JALA SE DECISION MADE: 01-JUN-09 KLANG MY 42100 510(k) STATEMENT DEVICE: REVLITE Q-SWITCHED ND:YAG LASER SYSTEM HOYA CONBIO, INC 510(k) NO: K083899(TRADITIONAL)
ATTN: LIZA BURNS PHONE NO : 209 586 0416 19722 WESTVIEW DRIVE SE DECISION MADE: 01-JUN-09 TWAIN HARTE CA 95383 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT MEDACTA INTERNATIONAL, SA 510(k) NO: K091069(TRADITIONAL)
ATTN: NATALIE J KENNEL PHONE NO : 858 705 0350 13721 VIA TRES VISTA SE DECISION MADE: 01-JUN-09 SAN DIEGO CA 92129 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOI SYSTEM PALOMAR MEDICAL PRODUCTS, INC. 510(k) NO: K090525(TRADITIONAL)
ATTN: SHARON TIMBERLAKE PHONE NO : 781 993 2414 82 CAMBRIDGE ST. SE DECISION MADE: 01-JUN-09 BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771 SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K090900(ABBREVIATED)
ATTN: KIRA GORDON PHONE NO : 914 524 2996 511 BENEDICT AVENUE SE DECISION MADE: 01-JUN-09 TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 263 TOTAL WITH SUMMARIES 235 TOTAL WITH STATEMENTS 28
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