510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD August 2016
TOTAL 510(k)s THIS PERIOD 252 TOTAL WITH SUMMARIES 235 TOTAL WITH STATEMENTS 17
DEVICE: CompleClear Plastic Orthodontic Bracket and Wire Appliance ORACREW 510(k) NO: K150830(Traditional) ATTN: PAWAN GAUTAM PHONE NO : 1 760 2370163 210 E Flamingo Rd. #217 SE DECISION MADE: 26-AUG-16 Las Vegas NV 89169 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MTA Repair HP ANGELUS INDUSTRIA DE PRODUCTOS ODO510(k) NO: K151047(Traditional) ATTN: Paulo Sergio Calixto de OliPHONE NO : 55 43 21013200 RUA WALDIR LANDGRAF, 101 SE DECISION MADE: 31-AUG-16 LONDRINA, PR BR 86031-218 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Double Medical Universal Spine System Double Medical Technology Inc 510(k) NO: K151458(Traditional) ATTN: DA ZENG PHONE NO : 86 592 6087078 No. 18 Shanbianhong East Road, HaiSE DECISION MADE: 22-AUG-16 XIAMEN CN 361022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A-Oss HIOSSEN INC. 510(k) NO: K151542(Traditional) ATTN: David Kim PHONE NO : 267 759 7031 85 BEN FAIRLESS DR. SE DECISION MADE: 03-AUG-16 FAIRLESS HILLS PA 19030 510(k) STATEMENT DEVICE: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile KOSSAN INTERNATIONAL SDN. BHD. 510(k) NO: K151750(Traditional) ATTN: CHO SOW FONG PHONE NO : 603 3291 0516 WISMA KOSSAN, LOT 782, JALAN SUNGASE DECISION MADE: 03-AUG-16 KLANG MY 42100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMEDIATELOAD Dental Implant System IMMEDIATELOAD S.A. 510(k) NO: K151757(Traditional) ATTN: GIOVANNI CANINO PHONE NO : 041 916 001310 VIA LUGANO 11 SE DECISION MADE: 03-AUG-16 AGNO CH 6982 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs KOSSAN INTERNATIONAL SDN. BHD. 510(k) NO: K151824(Traditional) ATTN: CHO SOW FONG PHONE NO : 603 32910516 WISMA KOSSAN, LOT 782, JALAN SUNGASE DECISION MADE: 02-AUG-16 KLANG MY 42100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Wrist Pulse Oximeter Jiangsu Konsung Bio-Medical Scienc510(k) NO: K152089(Traditional) ATTN: Li Xu PHONE NO : 86 511 86378639 NO. 8, Shengchang West Road,DanyanSE DECISION MADE: 17-AUG-16 Jiang Su CN 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Fingertip Pulse Oximeter Jiangsu Konsung Bio-Medical Scienc510(k) NO: K152091(Traditional) ATTN: Li Xu PHONE NO : 86 511 86378639 NO. 8, Shengchang West Road,DanyanSE DECISION MADE: 18-AUG-16 Jiang Su CN 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Oral Surgery System and Accessories BONART CO., LTD. 510(k) NO: K152125(Traditional) ATTN: BANKSON TSAI PHONE NO : 886 2 22983980 4F-1, NO. 3 WUQUAN 1ST RD. SE DECISION MADE: 15-AUG-16 XINZHUANG DIST. TW 24892 510(k) STATEMENT DEVICE: UST-5550-R; UST-5536-R; L43K HITACHI ALOKA MEDICAL AMERICA, INC510(k) NO: K152126(Traditional) ATTN: ANGELA VAN ARSDALE PHONE NO : 203 2695088 10 FAIRFIELD BLVD. SE DECISION MADE: 17-AUG-16 WALLINGFORD CT 06492-5903 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Quantitative Electrocardiographic Detector (QED 2000) ACME Portable Machines, Inc. 510(k) NO: K152135(Traditional) ATTN: James Cheng PHONE NO : 626 6101888 1330 Mountain View Circle SE DECISION MADE: 09-AUG-16 Azusa CA 91702 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Skypro, SP01 Mask Skypro Medical Supplies Company 510(k) NO: K152197(Traditional) ATTN: Cyrus Wong PHONE NO : 85 2 27110882 C301, Tsing Yi Industrial Centre PSE DECISION MADE: 26-AUG-16 Hong Kong CN 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) ION BEAM APPLICATION S.A. 510(k) NO: K152224(Traditional) ATTN: ANNE-SOPHIE GRELL PHONE NO : 0032 10 475816 CHEMIN DU CYCLTRON 3 SE DECISION MADE: 09-AUG-16 LOUVAIN-LA-NEUVE BE 1348 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Alians Elbow Locking Plating System NEWCLIP TECHNICS 510(k) NO: K152289(Traditional) ATTN: Gaelle LUSSORI PHONE NO : 33 228213712 PA de la Lande Saint Martin-45 rueSE DECISION MADE: 17-AUG-16 HAUTE-GOULAINE FR 44 115 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Medke Oximetry Finger Sensor Shenzhen Medke Technology Co., LTD510(k) NO: K152390(Traditional) ATTN: Lao Chengxin PHONE NO : 086 755 23463462 4/F,Bldg.A1,Anle Ind. Zone,HangcheSE DECISION MADE: 18-AUG-16 Shenzhen CN 518126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPO BULK FILL SCHUETZ DENTAL GMBH 510(k) NO: K152471(Traditional) ATTN: Anke Puent PHONE NO : 49 6003 814640 DIESELSTR. 5- 6 SE DECISION MADE: 04-AUG-16 ROSBACH DE 61191 510(k) STATEMENT DEVICE: LCCS Disposable RF Electrode, LCCS Reusable RF Electrode LCCS PRODUCTS LIMITED 510(k) NO: K152642(Traditional) ATTN: JAMES LIN PHONE NO : 852 82 321050 FLAT A, 9/F ., HENNESSY PLAZA, 164SE DECISION MADE: 26-AUG-16 HONG KONG CN 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: V10 MEDIANA CO., LTD 510(k) NO: K152659(Traditional) ATTN: KIM MIN HYE PHONE NO : 82 33 7425400 132, DONGHWAGONGDAN-RO, MUNMAK-EUPSE DECISION MADE: 25-AUG-16 WONJU-SI KR 220-801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10 COLONPLUS EQUIPMENTS & SPECULUMS, 510(k) NO: K152834(Traditional) ATTN: Jorge Echevarria PHONE NO : 34 943 265344 C/Portuetxe 13, 1 C 20018 SE DECISION MADE: 10-AUG-16 San Sebastian (Guipuzcoa) ES 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SACCADOMETER PLUS, SACCADOMETER ADVANCED OBER CONSULTING SP. Z.O.O. 510(k) NO: K152890(Traditional) ATTN: JAN KRZYSZTOF OBER PHONE NO : 048 505 940787 BRZECHWY 6 SE DECISION MADE: 11-AUG-16 POZNAN PL 60-195 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator AMBU A/S 510(k) NO: K152931(Abbreviated) ATTN: LINE KAGENOW SVENSTRUP PHONE NO : 45 7 2252000 BALTORPBAKKEN 13 SE DECISION MADE: 29-AUG-16 BALLERUP DK DK-2750 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WebPAX HEART IMAGING TECHNOLOGIES, LLC 510(k) NO: K152949(Traditional) ATTN: Robert Judd PHONE NO : 919 3233001 5003 SOUTHPARK DR. SUITE 140 SE DECISION MADE: 17-AUG-16 DURHAM NC 27713 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: The Hammertoe Correction System LIFE SPINE, INC 510(k) NO: K153065(Traditional) ATTN: Randy Lewis PHONE NO : 847 8846117 13951 S. Quality Drive SE DECISION MADE: 01-AUG-16 Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 'cottony' II TAPE, PLEDGETS Teleflex Medical, Inc. 510(k) NO: K153089(Traditional) ATTN: Natalie Hichak PHONE NO : 919 4338049 3015 Carrington Mill Blvd SE DECISION MADE: 12-AUG-16 Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) ZYNO MEDICAL LLC 510(k) NO: K153193(Abbreviated) ATTN: Mei Zhang PHONE NO : 508 6502008 177 PINE ST SE DECISION MADE: 30-AUG-16 NATICK MA 01760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SnoreRx Apnea Sciences Corporation 510(k) NO: K153200(Abbreviated) ATTN: James Fallon PHONE NO : 949 6802771 27121 Aliso Creek Road, Bldg 140 SE DECISION MADE: 09-AUG-16 Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IDSS ForceTriad Control Module BLACK DIAMOND VIDEO, INC 510(k) NO: K153205(Traditional) ATTN: Ragunath Muniandy PHONE NO : 510 4394500 503 CANAL BLVD SE DECISION MADE: 01-AUG-16 Richmond CA 94804 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply SMITH & NEPHEW MEDICAL LTD. 510(k) NO: K153209(Traditional) ATTN: LAURA REYNOLDS PHONE NO : 44 1482 673790 101 HESSLE RD. SE DECISION MADE: 04-AUG-16 HULL GB HU3 2BN 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Fehling-Punches Fehling Instruments GmbH & Co. KG 510(k) NO: K153243(Traditional) ATTN: Ulrike Lindner PHONE NO : 49 6188 95740 Hanauer Landstr. 7A SE DECISION MADE: 04-AUG-16 Karlstein DE D-63791 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Med-Tainer Single Deposit Container Snyder Industries, Inc. 510(k) NO: K153274(Traditional) ATTN: Herbert H Spann PHONE NO : 1 402 4675221 6940 O Street Suite 100 SE DECISION MADE: 04-AUG-16 Lincoln NE 68510 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: da Vinci Xi Surgical System INTUITIVE SURGICAL, INC. 510(k) NO: K153276(Traditional) ATTN: Brandon Hansen PHONE NO : 408 5232100 1266 KIFER ROAD SE DECISION MADE: 07-AUG-16 SUNNYVALE CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Wireless Smart Gluco-Monitoring System Andon Health Co., Ltd 510(k) NO: K153278(Traditional) ATTN: Yi Liu PHONE NO : 86 22 60526161 No. 3 Jinping Street, Ya'an Road, SE DECISION MADE: 19-AUG-16 Tianjin CN 300190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VivoSight Dx Topical OCT System Michelson Diagnostics Ltd 510(k) NO: K153283(Traditional) ATTN: Martin Johns PHONE NO : 00144 20 83081695 Ground Floor Eclipse House, EclipsSE DECISION MADE: 11-AUG-16 Maidstone GB me14 3en 510(k) STATEMENT DEVICE: EMS-200 META SYSTEMS CO., LTD. 510(k) NO: K153285(Traditional) ATTN: RAY JEON PHONE NO : 82 2 26273765 RM 607, BYUCKSAN DIGITAL VALLEY 6,SE DECISION MADE: 12-AUG-16 SEOUL KP 08501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: iHealth Align Gluco-Monitoring system Andon health Co., Ltd 510(k) NO: K153286(Traditional) ATTN: Yi Liu PHONE NO : 86 22 60526161 No. 3 Jimping Street, Ya'am Road, SE DECISION MADE: 19-AUG-16 Tianjin CN 300190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Perifix and Contiplex Catheter B. BRAUN MEDICAL INC 510(k) NO: K153297(Traditional) ATTN: LISA GIAQUINTO PHONE NO : 610 2660500 901 MARCON BLVD. SE DECISION MADE: 12-AUG-16 ALLENTOWN PA 18109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EUROIMMUN Anti-West Nile Virus ELISA (IgG) EUROIMMUN US, INC. 510(k) NO: K153303(Traditional) ATTN: Michael Locke PHONE NO : 973 6561000 1100 THE AMERICAN ROAD SE DECISION MADE: 10-AUG-16 MORRIS PLAINS NJ 07950 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EUROIMMUN Anti-West Nile Virus ELISA (IgM) EUROIMMUN US, INC. 510(k) NO: K153308(Traditional) ATTN: Michael Locke PHONE NO : 973 6561000 1100 THE AMERICAN ROAD SE DECISION MADE: 12-AUG-16 MORRIS PLAINS NJ 07950 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis MED-TECH WATER SYSTEMS INC 510(k) NO: K153329(Traditional) ATTN: BRIAN C KIM PHONE NO : 707 4271564 1755 WOOLNER AVENUE SUITE B SE DECISION MADE: 04-AUG-16 FAIRFIELD CA 94533 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit CODMAN & SHURTLEFF, INC. 510(k) NO: K153347(Traditional) ATTN: Megan Herman PHONE NO : 508 8283571 325 PARAMOUNT DR. SE DECISION MADE: 19-AUG-16 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System Spinal Elements Inc. 510(k) NO: K153352(Traditional) ATTN: Cecilia Silva PHONE NO : 760 6071830 3115 Melrose Dr., Suite 200 SE DECISION MADE: 01-AUG-16 Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Kerecis SecureMesh Kerecis Limited 510(k) NO: K153364(Traditional) ATTN: Gudmundur Fertram SigurjonssPHONE NO : 354 562 2601 Eyrargata 2 SE DECISION MADE: 19-AUG-16 Isafjordur IS 400 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls ABBOTT LABORATORIES 510(k) NO: K153375(Traditional) ATTN: LAURA YELVIGI JOGLEKAR PHONE NO : 1 224 6673503 DEPT 093E, BLDG. AP 8 100 ABBOTT PSE DECISION MADE: 12-AUG-16 ABBOTT PARK IL 60064-6038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S-Wire Guidewire System CONCERT MEDICAL, LLC 510(k) NO: K153397(Traditional) ATTN: Timothy S. Powers PHONE NO : 781 8717882 77 ACCORD PARK DR. SE DECISION MADE: 18-AUG-16 NORWELL MA 02061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set C.R BARD, INC. 510(k) NO: K153440(Traditional) ATTN: Darlene Hull PHONE NO : 801 5225613 605 NORTH 5600 WEST SE DECISION MADE: 18-AUG-16 Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Salto XT, Salto Talaris Tornier SAS 510(k) NO: K153452(Traditional) ATTN: Séverine BONNETON PHONE NO : 33 476 613500 161 rue Lavoisier SE DECISION MADE: 11-AUG-16 Montbonnot St. Martin FR 38330 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MADgic Laryngo-Tracheal Mucosal Atomization Device TELEFLEX MEDICAL 510(k) NO: K153470(Traditional) ATTN: Kristen Bisanz PHONE NO : 919 4334932 3015 SE DECISION MADE: 19-AUG-16 Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KATANA AVENCIA Block Kuraray Noritake Dental, Inc. 510(k) NO: K153476(Traditional) ATTN: Michio Takigawa PHONE NO : 81 3 67011706 Ote Center Bldg. 7F, 1-1-3, OtemacSE DECISION MADE: 23-AUG-16 Chiyoda ku JP 100-0004 510(k) STATEMENT DEVICE: Sydney IVF Gamete Buffer WILLIAM A. COOK AUSTRALIA PTY LTD 510(k) NO: K153478(Traditional) ATTN: Gordana Pozvek PHONE NO : 61 738 411188 95 BRANDL STREET SE DECISION MADE: 15-AUG-16 Eight Mile Plains AU 4113 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HQS Introducer (Model 2064-HQS) ALSEAL 510(k) NO: K153494(Traditional) ATTN: Jean-Francois M Delforge PHONE NO : 33 03 81616993 2, RUE DU PROFESSEUR MILLERET SE DECISION MADE: 25-AUG-16 Besancon FR 25000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GPS Angled Abutment IMPLANT DIRECT SYBRON MANUFACTURIN510(k) NO: K153509(Traditional) ATTN: DEBLEENA SINHA PHONE NO : 818 4443306 3050 EAST HILLCREST DRIVE SE DECISION MADE: 26-AUG-16 THOUSAND OAKS CA 91362 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Premium Plus C01/C02 LED Curing Light PREMIUM PLUS INTERNATIONAL LIMITED510(k) NO: K153514(Abbreviated) ATTN: Jessica Mao PHONE NO : 852 27 613211 FLAT 1001 YUEN LONG TRADING CENTRESE DECISION MADE: 22-AUG-16 HONG KONG CN 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators SAFE SECURE PACKAGING CO., LTD 510(k) NO: K153540(Traditional) ATTN: HOWARD JIA PHONE NO : 86 755 27040468 NO.4 CHENGGUANG INDUSTRIAL PARK GUSE DECISION MADE: 04-AUG-16 SHENZHEN CN 518100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSSIX VOLUMAX Datum Dental Ltd. 510(k) NO: K153549(Traditional) ATTN: Arie Goldlust PHONE NO : 972 8 6705400 1 Bat Sheva St., PO Box 6170 SE DECISION MADE: 04-AUG-16 Lod IL 7116003 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. Axis-Shield Diagnostics Limited. 510(k) NO: K153551(Traditional) ATTN: Claire I Dora PHONE NO : 44 0 1382422000 232 The Technology Park Luna Place SE DECISION MADE: 04-AUG-16 Dundee GB DD2 1XA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System Accelerated Care Plus (ACP) 510(k) NO: K153559(Traditional) ATTN: Patrick Parker PHONE NO : 800 3501100 1827 4999 Aircenter Circle, Ste. 103 SE DECISION MADE: 26-AUG-16 Reno NV 89502 510(k) STATEMENT DEVICE: Optilite Low Level Albumin Kit THE BINDING SITE GROUP LTD 510(k) NO: K153560(Traditional) ATTN: JON LAUDER PHONE NO : 44 0121 4569500 8 CALTHORPE ROAD, EDGBASTON SE DECISION MADE: 25-AUG-16 BIRMINGHAM GB B15 1QT 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cavilon Advanced High Endurance Skin Protectant 3M HEALTH CARE 510(k) NO: K153571(Traditional) ATTN: MARIA RUIZ PHONE NO : 651 7362733 3M CENTER, 2510 CONWAY AVE., BLDG SE DECISION MADE: 23-AUG-16 ST.PAUL MN 55144 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Converge BIOMEDICAL ENTERPRISES, INC 510(k) NO: K153573(Traditional) ATTN: Joe Soward PHONE NO : 210 6770354 14785 OMICRON DR., STE 205 SE DECISION MADE: 11-AUG-16 SAN ANTONIO TX 78245 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control ARK DIAGNOSTICS, INC. 510(k) NO: K153596(Traditional) ATTN: KENNETH C. KASPER PHONE NO : 510 2706280 48089 FREMONT BLVD. SE DECISION MADE: 09-AUG-16 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Exactech® Novation® Element Press-fit Femoral Stem EXACTECH INC 510(k) NO: K153649(Traditional) ATTN: Thomas McNamara PHONE NO : 352 3771140 2320 NW 66TH COURT SE DECISION MADE: 31-AUG-16 GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems BECKMAN COULTER, INC. 510(k) NO: K153651(Traditional) ATTN: MICHAEL ROBERT LORENZ PHONE NO : 952 3681361 Immunodiagnostic Development CenteSE DECISION MADE: 18-AUG-16 CHASKA MN 55318-1361 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove PERMEADERM, INC. 510(k) NO: K153678(Traditional) ATTN: AUBREY WOODROOF PHONE NO : 760 2711589 2905 SEGOVIA WAY SE DECISION MADE: 08-AUG-16 CARLSBAD CA 92009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Insulin Pen Needle STERILANCE MEDICAL (SUZHOU) INC. 510(k) NO: K153706(Traditional) ATTN: Juanjuan Sun PHONE NO : 86 512 65799308 68 LITANGHE RD., XIANGCHENG SE DECISION MADE: 29-AUG-16 SUZHOU CN 215113 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet DEVICOR MEDICAL PRODUCTS, INC. 510(k) NO: K153709(Traditional) ATTN: SHAWNA ROSE PHONE NO : 513 8649178 300 E-BUSINESS WAY, FIFTH FLOOR SE DECISION MADE: 08-AUG-16 Cincinnati OH 45241 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LifeFlow Rapid Infusion Device (LifeFlow Device) 410 Medical Innovation, LLC 510(k) NO: K153731(Traditional) ATTN: Galen Robertson PHONE NO : 844 4355450 201 West Main Street, Suite 305 SE DECISION MADE: 25-AUG-16 Durham NC 27701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Apollo Balloon Dilatation Catheter BrosMed Medical Co., Ltd. 510(k) NO: K153742(Traditional) ATTN: Tina Yin PHONE NO : 86 769 22892018 15th Bldg., SMEs Venture Park SongSE DECISION MADE: 08-AUG-16 Dongguan CN 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) A1 GLOVE SDN BHD 510(k) NO: K153744(Traditional) ATTN: CONNIE YUNG PHONE NO : 60 67999055 LOT 3726, KAWASAN PERINDUSTRIAN NISE DECISION MADE: 04-AUG-16 NILAI MY 71900 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Microlyte Ag IMBED BIOSCIENCES, INC. 510(k) NO: K153756(Traditional) ATTN: ANKIT AGARWA PHONE NO : 515 7081330 5520 NOBEL DRIVE SUITE 100 SE DECISION MADE: 04-AUG-16 MADISON WI 53711 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: H-Max S stem LIMACORPORATE S.P.A. 510(k) NO: K160011(Traditional) ATTN: EMANUELE BUTTAZZONI PHONE NO : 390 432 945511 VIA NAZIONALE 52 SE DECISION MADE: 22-AUG-16 VILLANOVA DI SAN DANIELE IT 33038510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUOFUCON Silicone Ag foam dressing HUIZHOU FORYOU MEDICAL DEVICES Co.510(k) NO: K160022(Traditional) ATTN: Guosheng Tan PHONE NO : 86 0752 5302012 NORTH SHANGXIA ROAD DONGJIANG HI-TSE DECISION MADE: 17-AUG-16 HUIZHOU CN 516005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Accent XL Alma Lasers Inc. 510(k) NO: K160075(Traditional) ATTN: Avi Farbstein PHONE NO : 224 3772000 485 Half Day Rd. Ste 100 SE DECISION MADE: 17-AUG-16 Buffalo Grove IL 60089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Image Fast Set, Image Regular Set Sybron Dental Specialties 510(k) NO: K160097(Traditional) ATTN: Gerardo Lara PHONE NO : 909 9625771 1717 W. Collins Ave SE DECISION MADE: 05-AUG-16 Orange CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUNA DENTAL IMPLANT SYSTEM SHINHUNG MST Co., Ltd 510(k) NO: K160106(Special) ATTN: Sunbyung Lee PHONE NO : 82 33 7301900 110-2, Donghwagongdan-Ro, Munmak-ESE DECISION MADE: 26-AUG-16 Wonju-Si KR 220-801 510(k) STATEMENT DEVICE: Adhesive Electrodes GMDASZ MANUFACTURING CO., LTD 510(k) NO: K160138(Traditional) ATTN: CHARLES MACK PHONE NO : 86 755 86213939 ROOM E1308, XIHAIMINGZHU BUILDINGSE DECISION MADE: 11-AUG-16 SHENZHEN CITY CN 518052 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CT TrueView PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K160147(Abbreviated) ATTN: JEANETTE BECKER PHONE NO : 31 6 11386380 VEENPLUIS 4-6 SE DECISION MADE: 10-AUG-16 BEST NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Miret Grasper, Alligator, Miret Grasper, Maryland MIRET SURGICAL INC. 510(k) NO: K160149(Traditional) ATTN: AVI ROOP PHONE NO : 630 3152520 205 E. BUTTERFIELD ROAD, SUITE 457SE DECISION MADE: 30-AUG-16 ELMHURST IL 60126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Hilal Embolization MicroCoils Cook Incorporated 510(k) NO: K160219(Traditional) ATTN: David Lehr PHONE NO : 812 3392235 102309 750 Daniels Way SE DECISION MADE: 03-AUG-16 Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TAP 3, TAP 1 Airway Management, Inc. 510(k) NO: K160239(Traditional) ATTN: Dale Siebenmorgen PHONE NO : 866 2647667 3418 Midcourt Road, Ste. 114 SE DECISION MADE: 10-AUG-16 Carrollton TX 75006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ArgenIS Titanium Abutments Argen Corporation 510(k) NO: K160248(Abbreviated) ATTN: Paul Cascone PHONE NO : 858 4557900 5855 Oberlin Dr SE DECISION MADE: 05-AUG-16 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Vitalograph Model 6300 micro VITALOGRAPH (IRELAND) LTD. 510(k) NO: K160253(Traditional) ATTN: TOM J HEALY PHONE NO : 3 5365 6864100 GORT ROAD BUSINESS PARK SE DECISION MADE: 26-AUG-16 ENNIS IE V95 HFT4 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Fuse Endoscopic System with FuseBox Processor EndoChoice Inc. 510(k) NO: K160275(Traditional) ATTN: Daniel Hoefer PHONE NO : 888 6823636 11810 Wills Rd SE DECISION MADE: 01-AUG-16 Alpharetta GA 30009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSSIX PLUS Datum Dental Ltd. 510(k) NO: K160281(Traditional) ATTN: Arie Goldlust PHONE NO : 972 8 6705400 1 Bat Sheva St., PO Box 6170 SE DECISION MADE: 04-AUG-16 Lod IL 7116003 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JointPoint JOINTPOINT, INC. 510(k) NO: K160284(Traditional) ATTN: Noah D. Wollowick PHONE NO : 617 6699794 402 BUTTONWOOD LANE SE DECISION MADE: 03-AUG-16 LARGO FL 33770 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: InMode System MiniFX Handpiece InMode MD Ltd. 510(k) NO: K160329(Traditional) ATTN: Amit Goren PHONE NO : 972 4 9096307 Tabor Building, Shaar Yokneam, POBSE DECISION MADE: 19-AUG-16 Yoqneam IL 20692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp Covidien 510(k) NO: K160331(Traditional) ATTN: Hong Zhu PHONE NO : 83 21 33230222 6F, Building 3, 2388 Chenhang RoadSE DECISION MADE: 12-AUG-16 Shanghai CN 201114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Triton System GAUSS SURGICAL INC. 510(k) NO: K160338(Traditional) ATTN: ARTIE KAUSHIK PHONE NO : 650 9494153 334 STATE STREET SUITE 201 SE DECISION MADE: 05-AUG-16 LOS ALTOS CA 94022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Electrosurgical disposable grounding pads TOP-RANK Health Care Co., Ltd 510(k) NO: K160366(Traditional) ATTN: Liubo Shen PHONE NO : 86 575 82912999 Checun Village, Dongguan Street, SSE DECISION MADE: 19-AUG-16 Shaoxing CN 312352 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Exufiber Ag+ MOLNLYCKE HEALTH CARE, US LLC 510(k) NO: K160379(Traditional) ATTN: MEGAN BEVILL PHONE NO : 470 3750049 5550 PEACHTREE PARKWAY, SUITE 500SE DECISION MADE: 25-AUG-16 NORCROSS GA 30092 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OT EQUATOR RHEIN'83 SRL 510(k) NO: K160382(Traditional) ATTN: CLAUDIA NARDI PHONE NO : 39 051 244510 VIA E. ZAGO 10/ABC SE DECISION MADE: 11-AUG-16 BOLOGNA IT 40128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Precision Point Biopsy Needle Guide Corbin Clinical Resources, LLC 510(k) NO: K160414(Traditional) ATTN: Kenneth K Kleinhenz PHONE NO : 858 4580900 12234 Williams Road SE DECISION MADE: 01-AUG-16 Cumberland MD 21502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AneurysmFlow PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K160455(Abbreviated) ATTN: Jeanette Becker PHONE NO : 31 611 386380 VEENPLUIS 4-6 SE DECISION MADE: 25-AUG-16 BEST NL 5684PC 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim Kossan International Sdn. Bhd. 510(k) NO: K160467(Traditional) ATTN: Cho Sow Fong PHONE NO : 603 3291 0516 Wisma Kossan, Lot 782, Jalan SungaSE DECISION MADE: 02-AUG-16 Klang MY 42100 510(k) STATEMENT DEVICE: Hidrocor, Hidrocharme, and Natural Colors SOLOTICA 510(k) NO: K160472(Traditional) ATTN: Gilberto Zablith PHONE NO : R DOMINGOS FASOLARI 110 -CASA VERDSE DECISION MADE: 10-AUG-16 SAO PAULO BR 02513-010 510(k) STATEMENT DEVICE: Burn-out Cylinder and Angled Screw Abutments Dentium Co., Ltd 510(k) NO: K160483(Abbreviated) ATTN: Sangpil Yoon PHONE NO : 82 31 2072200 150, Eondong-ro, Giheung-gu SE DECISION MADE: 05-AUG-16 Yongin-si KP 443-270 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengths Varian Medical Systems, Inc 510(k) NO: K160516(Traditional) ATTN: Peter J. Coronado PHONE NO : 650 4246320 911 Hansen Way SE DECISION MADE: 10-AUG-16 Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 5.0 Fr Arndt Endobronchial Blocker Set COOK INCORPORATED 510(k) NO: K160542(Special) ATTN: Kotei Aoki PHONE NO : 812 3353575 102630 750 DANIELS WAY SE DECISION MADE: 02-AUG-16 BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) HARTALEGA SDN BHD 510(k) NO: K160560(Traditional) ATTN: KUAN KAM HON PHONE NO : 60 62807 1733 C-G-9 JALAN DATARAN SD1 DATARAN SDSE DECISION MADE: 04-AUG-16 BANDAR SERI DAMANSARA MY 52200 510(k) STATEMENT DEVICE: Fully Automatic Electronic Blood Pressure Monitor ANDON HEALTH CO., LTD 510(k) NO: K160563(Abbreviated) ATTN: LIU YI PHONE NO : 86 226 0526161 9060 No.3 JIN PING STREET, YA AN ROAD, SE DECISION MADE: 04-AUG-16 TIANJIN CN 300190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Fully Automatic Electronic Blood Pressure Monitor ANDON HEALTH CO., LTD 510(k) NO: K160565(Abbreviated) ATTN: LIU YI PHONE NO : 86 226 0526161 9060 NO.3 JIN PING STREET,YA AN ROAD, NSE DECISION MADE: 10-AUG-16 Tianjin CN 300190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPERCATH 6 TOGO MEDIKIT CO., LTD. 510(k) NO: K160592(Traditional) ATTN: Daisuke Nagamizu PHONE NO : 81 982 538000 17148-6 Aza Kamekawa, Oaza HichiyaSE DECISION MADE: 12-AUG-16 Hyuga City JP 883-0062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INDEPENDENCE MIS Spacers GLOBUS MEDICAL INC. 510(k) NO: K160597(Traditional) ATTN: Kelly J. Baker PHONE NO : 610 9301800 1670 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 29-AUG-16 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Freedom Spinal Cord Stimulator System STIMWAVE TECHNOLOGIES INCORPORATED510(k) NO: K160600(Traditional) ATTN: Elizabeth Greene PHONE NO : 800 9655134 800 901 E LAS OLAS BLVD, SUITE 201 SE DECISION MADE: 26-AUG-16 FORT LAUDERDALE FL 33301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: P-ARTIS P-CURE LTD. 510(k) NO: K160611(Traditional) ATTN: MICHAEL MARASH PHONE NO : 972 8 6373030 12 ABBA HILLEL STREET SE DECISION MADE: 08-AUG-16 LOD IL 7129409 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sumitomo Proton Therapy System SUMITOMO HEAVY INDUSTRIES, LTD 510(k) NO: K160612(Traditional) ATTN: KATSUHIRO NARASAKI PHONE NO : 81 897 321479 5-2, SOBIRAKI-CHO SE DECISION MADE: 17-AUG-16 NIIHAMA JP 792-8588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHODONTIC CERAMIC BRACKETS 1.1 TOMY, INC 510(k) NO: K160615(Traditional) ATTN: JINICHI WATANABE PHONE NO : 81 246 423883 6 TENKO BLG. 3-16-7 SE DECISION MADE: 26-AUG-16 MIDORICHO, FUCHU CITY JP 183-0006510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATLANTIS Abutment for HIOSSEN ET implant DENTSPLY SIRONA 510(k) NO: K160626(Traditional) ATTN: Helen Lewis PHONE NO : 717 4871332 221 WEST PHILADELPHIA STREET SUITESE DECISION MADE: 29-AUG-16 York PA 17404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Vantage Titan 1.5T, MRT-1510, V3.6 Software TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K160632(Traditional) ATTN: Paul Biggins PHONE NO : 714 6697808 1385 SHIMOISHIGAMI SE DECISION MADE: 23-AUG-16 OTAWARA-SHI JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: iPEP System and vPEP D R BURTON HEALTHCARE LLC 510(k) NO: K160636(Traditional) ATTN: DENNIS COOK PHONE NO : 847 6410500 3936 S FIELDS ST SE DECISION MADE: 03-AUG-16 FARMVILLE NC 27828 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XYcor® Expandable Spinal Spacer System Alphatec Spine, Inc 510(k) NO: K160646(Traditional) ATTN: Renee Murphy PHONE NO : 760 4946739 5818 El Camino Real SE DECISION MADE: 24-AUG-16 Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® UNOMEDICAL A/S 510(k) NO: K160648(Traditional) ATTN: John M Lindskog PHONE NO : 45 46 427810 AAHOLMVEJ 1-3 SE DECISION MADE: 10-AUG-16 OSTED DK 4320 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIAISON HAV IgM, LIAISON Control HAV IgM DiaSorin Inc. 510(k) NO: K160650(Traditional) ATTN: John Walter PHONE NO : 651 9710 1951 Northwestern Avenue SE DECISION MADE: 25-AUG-16 Stillwater MN 55082-0285 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Aqueduct 100 Cervical Dilator GTIMD LLC 510(k) NO: K160664(Abbreviated) ATTN: RICHARD DEMELLO PHONE NO : 603 8800277 6 COLUMBIA DRIVE SE DECISION MADE: 01-AUG-16 AMHERST NH 03031 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Powder free vinyl patient examination glove, colored (yellow) KAIXING PLASTIC PRODUCTS CO., LITD510(k) NO: K160675(Traditional) ATTN: Dan ny PHONE NO : 86 315 4167693 1101 TANGGANG RD LUANNAN COUNTY SE DECISION MADE: 02-AUG-16 Tangshan CN 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WoundClot9 CORE SCIENTIFIC CREATION LTD. 510(k) NO: K160679(Traditional) ATTN: YUVAL YASKIL PHONE NO : 972 978 81919 YOHANAN HASANDLAR 4 ST. POB 2270, SE DECISION MADE: 08-AUG-16 Kfar Saba IL 4464102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Surveyor S4 Mobile Monitor Mortara Instrument, Inc. 510(k) NO: K160685(Traditional) ATTN: Sarah Weber PHONE NO : 414 3541600 7865 North 86th Street SE DECISION MADE: 04-AUG-16 Milwaukee WI 53224 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIRTU Lumbar Spacer System Met 1 Technologies, LLC 510(k) NO: K160699(Traditional) ATTN: Dan Gerbec PHONE NO : 915 3010834 154 N. Festival Dr., Ste. F SE DECISION MADE: 01-AUG-16 El Paso TX 79912 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZION Anterior Cervical Fixation System Astura Medical 510(k) NO: K160702(Traditional) ATTN: TROY TAYLOR PHONE NO : 760 8148047 5670 El Camino Real, Suite B SE DECISION MADE: 23-AUG-16 Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OnSight 3D Extremity System CARESTREAM HEALTH, INC. 510(k) NO: K160723(Traditional) ATTN: Carolyn Wagner PHONE NO : 585 6276588 150 VERONA STREET SE DECISION MADE: 30-AUG-16 Rochester NY 14608 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Philips Ingenuity CT Philips Medical Systems (Cleveland510(k) NO: K160743(Traditional) ATTN: Susan Quick PHONE NO : 440 4832290 595 Miner Rd SE DECISION MADE: 08-AUG-16 Cleveland OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AirLife Autofill Humidification Chamber CAREFUSION 2200, INC. 510(k) NO: K160764(Traditional) ATTN: ERIKA FERNANDEZ PHONE NO : 847 3628097 75 N. FAIRWAY DR. SE DECISION MADE: 25-AUG-16 VERNON HILLS IL 60061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Ambu USR, Ambu M AMBU A/S 510(k) NO: K160766(Traditional) ATTN: CAMILLA WISMAR PHONE NO : 45 722 52000 BALTORPBAKKEN 13 SE DECISION MADE: 17-AUG-16 BALLERUP DK DK-2750 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IonoStar Plus VOCO GMBH 510(k) NO: K160774(Traditional) ATTN: M. TH. PLAUMANN PHONE NO : 49 4721 719200 ANTON-FLETTNER-STR. 1-3 SE DECISION MADE: 03-AUG-16 CUXHAVEN DE 27472 510(k) STATEMENT DEVICE: Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet SYNCRO MEDICAL INNOVATIONS, INC. 510(k) NO: K160787(Traditional) ATTN: Sabry Gabriel PHONE NO : 478 3358311 515 Mulberry Street, Suite 200 SE DECISION MADE: 09-AUG-16 Macon GA 31201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline) W.H.P.M., INC. 510(k) NO: K160793(Traditional) ATTN: John Wan PHONE NO : 626 4438480 5358 IRWINDALE AVE. SE DECISION MADE: 17-AUG-16 IRWINDALE CA 91706 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FMX314 Surgical Platform Fortimedix Surgical B.V. 510(k) NO: K160797(Traditional) ATTN: DIRKJAN BAKKER PHONE NO : 31 045 5449520 Daelderweg 20 SE DECISION MADE: 26-AUG-16 Nuth NL 6361 HK 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Infrared Forehead Thermometer, FT-100A HANGZHOU UNIVERSAL ELECTRONIC CO.,510(k) NO: K160802(Traditional) ATTN: JIAQIANG WAN PHONE NO : 86 571 88308206 38 YANGJIATANG, SANDUN, WESTLAKE DSE DECISION MADE: 24-AUG-16 HANGZHOU CITY CN 310030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Verza Guidance System CIVCO MEDICAL INSTRUMENTS CO., INC510(k) NO: K160806(Traditional) ATTN: Amanda Stahle PHONE NO : 319 2486628 102 FIRST ST. SOUTH SE DECISION MADE: 05-AUG-16 KALONA IA 52247 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECG100+, ECG200+ CARDIOLINE S.p.A 510(k) NO: K160840(Traditional) ATTN: EMANUELE ERCOLI PHONE NO : 039 0463 850125 VIA LINZ 19/20/21 SE DECISION MADE: 12-AUG-16 SPINI DI GARDOLO IT 38121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SpineView X-Pac Expandable Lumbar Cage System Spine View, Inc. 510(k) NO: K160856(Traditional) ATTN: Mbithi Muthini PHONE NO : 510 7435090 48810 Kato Road, Suite 100E SE DECISION MADE: 01-AUG-16 Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8102AA/8102AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8100Q2 Reusable, Ear Clip Pulse Oximeter Sensor, Model 8101Q2 Reusable, Ear Clip Pulse Oximeter Sensor, and Model 8102Q2 Reusable, Ear Clip Pulse Oximeter Sensor NONIN MEDICAL, INC. 510(k) NO: K160865(Traditional) ATTN: NANCY E. DEANGELO PHONE NO : 763 5339968 2674 13700 1ST AVE. NORTH SE DECISION MADE: 05-AUG-16 PLYMOUTH MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 8ch Foot Ankle Coil Shenzhen RF Tech Co., Ltd. 510(k) NO: K160932(Traditional) ATTN: Ke Xi PHONE NO : 86 755 26641989 2-F, Bld4, Juhui Industrial Park, SE DECISION MADE: 01-AUG-16 Shenzhen CN 518132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Senolris GE Healthcare 510(k) NO: K160937(Traditional) ATTN: Mounir Zaouali PHONE NO : 49 89 962810 Oskar-Schlemmer-Str. 11 SE DECISION MADE: 01-AUG-16 Munich DE D-80807 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens SynergEyes, Inc. 510(k) NO: K160938(Traditional) ATTN: James Kirchner PHONE NO : 44 1799 542000 5927 PRIESTLY DR, SUITE210 SE DECISION MADE: 01-AUG-16 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Bite Away Riemser Pharma 510(k) NO: K160943(Traditional) ATTN: Ronny Raasch PHONE NO : 49 3033 84270 An der Wiek 7 SE DECISION MADE: 26-AUG-16 Greifswald-Insel Riems DE D-17493510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCU-CHEK Guide Blood Glucose Monitoring System Roche Diabetes Care, Inc. 510(k) NO: K160944(Traditional) ATTN: Khone Saysana PHONE NO : 317 5217593 9115 Hague Road SE DECISION MADE: 31-AUG-16 Indianapolis IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Kyphon HV-R Bone Cement MEDTRONIC INC 510(k) NO: K160983(Traditional) ATTN: PAMELA EDWARDS PHONE NO : 901 3963133 1800 PYRAMID PLACE SE DECISION MADE: 24-AUG-16 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Infra-red forehead thermometer HANGZHOU HUA'AN MEDICAL&HEALTH INS510(k) NO: K160999(Traditional) ATTN: AHNEO YANG PHONE NO : 86 571 88734065 BUILDING 2, 1# FUZHU NAN RD, WUCHASE DECISION MADE: 01-AUG-16 HANGZHOU CN 310023 510(k) STATEMENT DEVICE: Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove HARTALEGA SDN. BHD. 510(k) NO: K161006(Traditional) ATTN: KUAN KAM HON PHONE NO : 603 6277 1733 DATARAN SD PJU 9 SE DECISION MADE: 04-AUG-16 BANDAR SRI DAMANSARA MY 52200 510(k) STATEMENT DEVICE: Uroview FD PAUSCH MEDICAL GMBH 510(k) NO: K161019(Traditional) ATTN: Christian Stoian PHONE NO : 49 091 3199920 GRAF-ZEPPELIN-STRABE 1 SE DECISION MADE: 17-AUG-16 Erlangen DE D-91056 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm) MARVAO MEDICAL DEVICES, LTD. 510(k) NO: K161026(Traditional) ATTN: Christopher Davey PHONE NO : 353 091 759301 GMIT INNOVATION IN BUSINESS CENTRESE DECISION MADE: 09-AUG-16 GALWAY IE H91 DCH9 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATLANTIS Abutment for CONELOG implant Dentsply Sirona 510(k) NO: K161030(Traditional) ATTN: Helen Lewis PHONE NO : 717 4871332 221 West Philadephia Street SE DECISION MADE: 26-AUG-16 York PA 17404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AFX™ Femoral Implant With Inserter CAYENNE MEDICAL, INC. 510(k) NO: K161033(Special) ATTN: SHIMA HASHEMIAN PHONE NO : 480 5023661 249 16597 N 92ND STREET SE DECISION MADE: 03-AUG-16 SCOTTSDALE AZ 85260 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Microcyn Plus Wound Care Solution OCULUS INNOVATIVE SCIENCES 510(k) NO: K161034(Traditional) ATTN: BRIAN W. MARTIN PHONE NO : 707 2830550 1129 N. MCDOWELL BOULEVARD SE DECISION MADE: 19-AUG-16 PETALUMA CA 94954 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Tarsa-Link Stand-Alone Wedge Fixation System LIFE SPINE INC. 510(k) NO: K161037(Traditional) ATTN: RANDY LEWIS PHONE NO : 847 8846117 13951 S QUALITY DRIVE SE DECISION MADE: 15-AUG-16 HUNTLEY IL 60142 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SpotLight CT Arineta Ltd. 510(k) NO: K161066(Traditional) ATTN: Ehud Dafni PHONE NO : 011 972 46374000 15 Halamish Street SE DECISION MADE: 10-AUG-16 Caesarea IL 3088900 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GalaSHAPE 3D Tepha, Inc. 510(k) NO: K161092((Traditional) ATTN: Connie H Garrison PHONE NO : 781 3571709 99 Hayden Avenue SE DECISION MADE: 23-AUG-16 Lexington MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color) JOOWON INNOVATION CO., LTD. 510(k) NO: K161098(Traditional) ATTN: LEE HAE-HANG PHONE NO : 82 415 826117 44, SURETEO 1-GIL SE DECISION MADE: 22-AUG-16 CHEONAN-SI, SEOBUK-GU KR 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses CONTAMAC LTD. 510(k) NO: K161100(Traditional) ATTN: ROB MCGREGOR PHONE NO : 44 179 9542000 CARLTON HOUSE SHIRE HILL SE DECISION MADE: 10-AUG-16 SAFFRON WALDEN GB CB11 3AU 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Reprocessed Compression Garments COVIDIEN 510(k) NO: K161105(Traditional) ATTN: WING NG PHONE NO : 508 2616596 15 HAMPSHIRE STREET SE DECISION MADE: 18-AUG-16 MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Arthrex VaultLock Glenoid ARTHREX, INC. 510(k) NO: K161108(Special) ATTN: Courtney Smith PHONE NO : 239 6435553 71720 1370 Creekside Boulevard SE DECISION MADE: 29-AUG-16 Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QXLink VIEWORKS CO., LTD. 510(k) NO: K161113(Special) ATTN: YOONJAE IM PHONE NO : 82 707 0116176 (GWANYANG-DONG) 41-3, BURIM-RO 170SE DECISION MADE: 05-AUG-16 ANYANG-SI KR 431-060 510(k) STATEMENT DEVICE: EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear VISION SCIENCE CO.,LTD. 510(k) NO: K161124(Traditional) ATTN: OH IN-WHAN PHONE NO : 82 53 8573578 7, JAIN-RO 7-GIL, JIAN-MYEON SE DECISION MADE: 26-AUG-16 GYEONGSANGBUK-DO KR 712852 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASAHI Corsair Pro ASAHI INTECC CO., LTD. 510(k) NO: K161126(Traditional) ATTN: CARROLL COUNCILMAN PHONE NO : 949 7568252 1703 WAKITA-CHO, MORIYAMA-KU SE DECISION MADE: 25-AUG-16 NAGOYA JP 463-0024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ResolutionMD CALGARY SCIENTIFIC, INC. 510(k) NO: K161130(Traditional) ATTN: Kyle Peterson PHONE NO : 403 7677945 SUITE 208, 1210- 20TH AVENUE SE SE DECISION MADE: 24-AUG-16 CALGARY CA T2G 1M8 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: icobrain Icometrix 510(k) NO: K161148(Traditional) ATTN: Dirk Loeckx PHONE NO : 32 16 849697 Tervuuresteenweg 224 SE DECISION MADE: 09-AUG-16 Leuven BE 3001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PressureWire X Guidewire ST. JUDE MEDICAL INC. 510(k) NO: K161171(Traditional) ATTN: HUDA YUSUF PHONE NO : 612 9009527 5050 NATHAN LANE NORTH SE DECISION MADE: 15-AUG-16 PLYMOUTH MN 55442 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Solana Trichomonas Assay QUIDEL CORPORATION 510(k) NO: K161182(Traditional) ATTN: RONALD H LOLLAR PHONE NO : 740 5893373 2005 EAST STATE STREET, SUITE 100 SE DECISION MADE: 15-AUG-16 ATHENS OH 45701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Integra TITAN Reverse Shoulder System INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K161189(Traditional) ATTN: William Garzon PHONE NO : 512 5968908 8700 CAMERON ROAD, SUITE 100 SE DECISION MADE: 25-AUG-16 AUSTIN TX 78754 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors) M3 GLOBAL ENTERPRISES, LLC 510(k) NO: K161195(Abbreviated) ATTN: NEIL MEHTA PHONE NO : 70 BIRCH ALLEY, SUITE 240 BUILDINGSE DECISION MADE: 25-AUG-16 BEAVERCREEK OH 45440 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOMATOM Drive Siemens Medical Solutions USA, Inc510(k) NO: K161196(Traditional) ATTN: Kimberly Mangum PHONE NO : 610 4486477 65 Valley Stream Parkway SE DECISION MADE: 24-AUG-16 Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EndyMed Contour Handpiece ENDYMED MEDICAL LTD. 510(k) NO: K161199(Traditional) ATTN: Yoram Levy PHONE NO : 972 463 09100 12 LESHEM STREET NORTH INDUSTRIAL SE DECISION MADE: 01-AUG-16 Caesarea IL 3088900 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems Medtronic Sofamor Danek 510(k) NO: K161210((Traditional) ATTN: Ankit K. Shah PHONE NO : 901 3441272 1800 Pyramid Place SE DECISION MADE: 12-AUG-16 Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Digital Thermometer BIOCARE ASIA CORPORATION LTD. 510(k) NO: K161211(Traditional) ATTN: KE-MIN JEN PHONE NO : 86 512 68091772 NO.260, MAYUN ROAD NEW DISTRICT SE DECISION MADE: 29-AUG-16 SUZHOU CN 215129 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARIES® Flu A/B & RSV Assay LUMINEX CORPORATION 510(k) NO: K161220(Traditional) ATTN: WENDY RICKER PHONE NO : 608 2038936 12212 TECHNOLOGY BLVD SE DECISION MADE: 02-AUG-16 AUSTIN TX 78727 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3 GE Medical Systems Ultrasound & Pr510(k) NO: K161224(Traditional) ATTN: Tracey Ortiz PHONE NO : 262 6766120 9900 W. Innovation Drive SE DECISION MADE: 05-AUG-16 Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NuVasive Lumbar Interbody Implants NUVASIVE, INCORPORATED 510(k) NO: K161230(Traditional) ATTN: MARTIN YAHIRO PHONE NO : 858 3205257 7475 LUSK BLVD. SE DECISION MADE: 25-AUG-16 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CASSI II Rotational Core Biopsy System Scion Medical Technologies, LLC 510(k) NO: K161234(Special) ATTN: Louis Li PHONE NO : 888 5826211 4613 West Chester Pike SE DECISION MADE: 03-AUG-16 Newton Square PA 19073 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Rhythm View Workstation (non-streaming) Abbott Electrophysiology 510(k) NO: K161240(Traditional) ATTN: Dennis Pozzo PHONE NO : 314 3006580 1530 Obrien Drive, Suite B SE DECISION MADE: 10-AUG-16 Menlo Park CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EP-TRACER System CARDIO TEK, BV 510(k) NO: K161245(Traditional) ATTN: OLIVER ROTH PHONE NO : AMERIKALAAN 70 SE DECISION MADE: 05-AUG-16 ae maastricht-airport limburg NL 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Streamline 6495 Bipolar Temporary Myocardial Pacing Lead Medtronic 510(k) NO: K161249(Special) ATTN: Debra Taitague PHONE NO : 234 2484186 1801 East Deere Ave SE DECISION MADE: 19-AUG-16 Santa Ana CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests Hangzhou Clongene Biotech Co., Ltd510(k) NO: K161251(Traditional) ATTN: Zheng Shujian PHONE NO : 86 571 88262120 Building 4, No. 20 Longquan Road, SE DECISION MADE: 30-AUG-16 Hangzhou CN 311121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Athena Breast Pump EXPLORAMED NC7, INC 510(k) NO: K161266(Traditional) ATTN: JOHN CHANG PHONE NO : 650 5500089 2639A TERMINAL BLVD SE DECISION MADE: 11-AUG-16 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Response BandLoc Spinal Fixation ORTHOPEDIATRICS CORP. 510(k) NO: K161267(Traditional) ATTN: MARK FOX PHONE NO : 574 2686379 2850 FRONTIER DRIVE SE DECISION MADE: 11-AUG-16 WARSAW IN 46538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CELTRA Press DENTSPLY SIRONA 510(k) NO: K161269(Traditional) ATTN: HELEN LEWIS PHONE NO : 717 4871332 221 WEST PHILADELPHIA STREET, SUITSE DECISION MADE: 12-AUG-16 YORK PA 17404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cerafix Dura Substitute ACERA SURGICAL, INC. 510(k) NO: K161278(Traditional) ATTN: Matthew MacEwan PHONE NO : 440 4471890 10880 BAUR BLVD. SE DECISION MADE: 08-AUG-16 ST. LOUIS MO 63132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IPL Therapy Machine BEIJING ADSS DEVELOPMENT CO., LTD510(k) NO: K161286(Traditional) ATTN: YURONG GAO PHONE NO : 86 10 83625120 F6, XIANDAO BLDG.,JINYUAN RD. 36, SE DECISION MADE: 04-AUG-16 BEIJING CN 102628 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak MEDTRONIC VASCULAR 510(k) NO: K161287(Traditional) ATTN: Nisarg Shah PHONE NO : 978 7396632 37A CHERRY HILL DR SE DECISION MADE: 19-AUG-16 DANVERS MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DURAFIBER Ag SMITH & NEPHEW MEDICAL LIMITED 510(k) NO: K161289(Traditional) ATTN: Samantha Neilson PHONE NO : 44 1482 673790 101 HESSLE RD SE DECISION MADE: 03-AUG-16 HULL GB HU3 2BN 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Distal Radius Plating System MIAMI DEVICE SOLUTIONS, LLC 510(k) NO: K161292(Traditional) ATTN: MARKKU BIEDERMANN PHONE NO : 786 4221400 7620 NW 25TH STREET UNIT 3 SE DECISION MADE: 15-AUG-16 MIAMI FL 33122 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial BECTON DICKINSON 510(k) NO: K161306(Traditional) ATTN: ASHANTI C. BROWN PHONE NO : 410 3164766 7 LOVETON CIRCLE, MC 694 SE DECISION MADE: 08-AUG-16 SPARKS MD 21152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,250 mL and 500 mL bottles, USP Sterile Normal Saline (0.9% sodium chloride), 100 mL, 250 mL and 500 mL bottles STRUKMYER MEDICAL LLC 510(k) NO: K161311(Traditional) ATTN: ROBERT DELK PHONE NO : 214 2759595 1801 BIG TOWN SUITE 100 SE DECISION MADE: 29-AUG-16 MESQUITE TX 75149 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology ARROW INTERNATIONAL, INC. (SUBSIDI510(k) NO: K161313(Traditional) ATTN: JULIE LAWSON PHONE NO : 610 3780131 2400 BERNVILLE ROAD SE DECISION MADE: 24-AUG-16 READING PA 19605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Vein Clamps, Artery Clamps AROS Surgical Instruments Corporat510(k) NO: K161315(Special) ATTN: Fred Phleps PHONE NO : 949 6409932262 2111 Descanso SE DECISION MADE: 18-AUG-16 Newport Beach CA 92660 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Raycell Mk2 Best Theratronics Limited 510(k) NO: K161324(Special) ATTN: MIKE DE VAN DER SCHUEREN PHONE NO : 613 5912100 413 March Road SE DECISION MADE: 12-AUG-16 Ottawa CA k2k 0e4 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HyperSound Tinnitus Module TURTLE BEACH CORPORATION 510(k) NO: K161331(Traditional) ATTN: JAMES A. BARNES PHONE NO : 888 4968001 12220 SCRIPPS SUMMIT DRIVE, SUITE SE DECISION MADE: 23-AUG-16 SAN DIEGO CA 92131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VSI StraitSet micro-introducer kit VASCULAR SOLUTIONS, INC. 510(k) NO: K161336(Traditional) ATTN: ADAM ETTL PHONE NO : 763 6564300 6464 SYCAMORE COURT NORTH SE DECISION MADE: 11-AUG-16 MINNEAPOLIS MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: invendoscopy E200 System Invendo Medical GmbH 510(k) NO: K161355(Traditional) ATTN: Oliver V. Ruepprecht PHONE NO : 0049 8233 7449816 Peterhofstr. 3b SE DECISION MADE: 25-AUG-16 Kissing DE 86438 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HydroCoil Embolic System (HES) MICROVENTION, INC. 510(k) NO: K161367((Special) ATTN: SAPNA SINGH PHONE NO : 714 2478162 1311 VALENCIA AVENUE SE DECISION MADE: 31-AUG-16 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit ALERE SCARBOROUGH, INC. 510(k) NO: K161375(Traditional) ATTN: Ashley Lucas PHONE NO : 207 7305789 10 SOUTHGATE ROAD SE DECISION MADE: 18-AUG-16 SCARBOROUGH ME 04074 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DragonFly Surgical Drill System Grace Medical, Inc. 510(k) NO: K161376(Third Party - Traditional) ATTN: William Graham PHONE NO : 8500 Wolf Lake Drive Suite 110 SE DECISION MADE: 25-AUG-16 Memphis TN 38133 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Just Like Me Personal Lubricant WTFN-dba Classic Erotica/Holiday P510(k) NO: K161385(Traditional) ATTN: Christina Zaragoza PHONE NO : 818 7734211 20950 Lassen Street SE DECISION MADE: 17-AUG-16 Chatsworth CA 91311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Mont Blanc and Mont Blanc MIS Spinal Systems SPINEWAY S.A. 510(k) NO: K161387(Traditional) ATTN: NICOLAS ROTH PHONE NO : 33 047 2770152 7 ALLEE MOULIN BERGER SE DECISION MADE: 04-AUG-16 ECULLY FR 69130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPEC Model M23 Source Production and Equipment Co510(k) NO: K161396(Traditional) ATTN: Kelley Richardt PHONE NO : 504 4649471 113 Teal Street SE DECISION MADE: 17-AUG-16 Saint Rose LA 70087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGiC GE Medical Systems, LLC 510(k) NO: K161397(Traditional) ATTN: Mary A. Mayka PHONE NO : 262 5273148 3200 Grandview Blvd SE DECISION MADE: 31-AUG-16 Waukesha WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Bullfrog Micro-Infusion Device MERCATOR MEDSYSTEMS, INC. 510(k) NO: K161402(Traditional) ATTN: Kirk P. Seward PHONE NO : 510 6144550 1900 POWELL STREET SUITE 800 SE DECISION MADE: 18-AUG-16 Emeryville CA 94608 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A.R.C. Laser Surgical Fibers and Probes A.R.C. LASER GMBH 510(k) NO: K161403(Traditional) ATTN: ANGELA THYZEL PHONE NO : 49 911 2177900 BESSEMER ST. 14 SE DECISION MADE: 16-AUG-16 NURNBERG DE 90411 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Valeo II Interbody Fusion Device System AMEDICA CORP. 510(k) NO: K161405(Special) ATTN: William D. Jordan PHONE NO : 801 8393562 1885 WEST 2100 SOUTH SE DECISION MADE: 19-AUG-16 Salt Lake City UT 84119 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem Mermaid Medical A/S 510(k) NO: K161409(Traditional) ATTN: Pia Wissing Jensen PHONE NO : 45 47 108570 Frydensbergvej 25 SE DECISION MADE: 02-AUG-16 Stenloese DK DK3660 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C ADAPTA MEDICAL, INC 510(k) NO: K161445(Special) ATTN: Adrian Elfe PHONE NO : 719 3281234 142 TALAMINE COURT SE DECISION MADE: 16-AUG-16 COLORADO SPRINGS CO 80907 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MicroPlex Coil System (MCS) - HyperSoft 3D MICROVENTION, INC. 510(k) NO: K161452((Special) ATTN: SAPNA SINGH PHONE NO : 714 2478162 1311 VALENCIA AVENUE SE DECISION MADE: 31-AUG-16 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Streamline OCT Occipito-Cervico-Thoracic System Pioneer Surgical Technology, Inc. 510(k) NO: K161498(Traditional) ATTN: Sarah Pleaugh PHONE NO : 906 2255861 375 River Park Circle SE DECISION MADE: 22-AUG-16 Marquette MI 49855 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MC1 Plus GENERAL PROJECT S.R.L. 510(k) NO: K161502(Special) ATTN: MORENO NALDONI PHONE NO : 011 39 0571675076 VIA DELLA GORA 15/19 SE DECISION MADE: 16-AUG-16 MONTESPERTOLI IT 50025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORION YERIM ENGINEERING Co., Ltd. 510(k) NO: K161503(Traditional) ATTN: Won Gil Jeon PHONE NO : 82 31 9919841 Ga-307, Techno-zone ,117, HwanggeuSE DECISION MADE: 26-AUG-16 Gimpo-si KP 415843 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DyeVert NG Contrast Modulation System OSPREY MEDICAL, INC. 510(k) NO: K161505(Special) ATTN: MELANIE HESS PHONE NO : 952 9558252 5600 ROWLAND ROAD SUITE 250 SE DECISION MADE: 03-AUG-16 MINNETONKA MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Anti-Borrelia burgdorferi US Westernblot (IgG) EUROIMMUN US 510(k) NO: K161513(Traditional) ATTN: MICHAEL LOCKE PHONE NO : 973 6561000 1100 THE AMERICAN ROAD SE DECISION MADE: 25-AUG-16 MORRIS PLAINS NJ 07950 510(k) STATEMENT DEVICE: G Surgical Marksman MIS System G SURGICAL LLC 510(k) NO: K161516(Traditional) ATTN: Donald Grafton PHONE NO : 720 6384287 5757 Central Ave, Suite G SE DECISION MADE: 25-AUG-16 Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PACS CORE/ENCORE COMPANIA MEXICANA DE RADIOLOGIA CG510(k) NO: K161518(Traditional) ATTN: Felipe Cuaranta Monroy PHONE NO : 52 442 2215000 138 FRACCIONAMIENTO INDUSTRIAL S/N SE DECISION MADE: 17-AUG-16 EL MARQUES QUERETARO MX 76240 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Philips Avent Comfort Single/Twin Electric Breast Pump Philips Consumer Lifestyle-Innovat510(k) NO: K161532(Traditional) ATTN: Marta Walker PHONE NO : 31 6 31978546 High Tech Campus 37 SE DECISION MADE: 29-AUG-16 Eindhoven NL 5656 AE 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Trojan Chain Reaction Personal Lubricant CHURCH & DWIGHT CO., INC. 510(k) NO: K161544(Traditional) ATTN: Lisa Burns PHONE NO : 609 8061997 500 CHARLES EWING BOULEVARD SE DECISION MADE: 31-AUG-16 EWING NJ 08628 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant CHURCH & DWIGHT CO., INC. 510(k) NO: K161545(Traditional) ATTN: Lisa Burns PHONE NO : 609 8061200 500 CHARLES EWING BLVD SE DECISION MADE: 26-AUG-16 Ewing NJ 08628 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large LC Medical Concepts, Inc. 510(k) NO: K161570(Traditional) ATTN: Dana M. Ledgerwood PHONE NO : 585 2037652 PO Box 502 SE DECISION MADE: 29-AUG-16 Penfield NY 14526 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Discovery MI GE Medical Systems, L.L.C. 510(k) NO: K161574(Traditional) ATTN: Helen Peng PHONE NO : 262 5485091 3000 N Grandview Blvd SE DECISION MADE: 11-AUG-16 Waukesha WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Affirm Lateral Arm Upright Biopsy Accessory HOLOGIC 510(k) NO: K161575(Traditional) ATTN: DEBBIE PEACOCK PHONE NO : 203 7027794 36 APPLE RIDGE ROAD SE DECISION MADE: 10-AUG-16 DANBURY CT 06810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Vscan Extend GE MEDICAL SYSTEMS ULTRASOUND & PR510(k) NO: K161588(Traditional) ATTN: Tracey Ortiz PHONE NO : 262 6766120 9900 W. INNOVATION DRIVE SE DECISION MADE: 31-AUG-16 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Accurett H&O EQUIPMENTS, NV/SA 510(k) NO: K161615(Special) ATTN: Aline Franck PHONE NO : 32 682 68600 RUE DES JOURNALIERS 1 SE DECISION MADE: 23-AUG-16 Ghislenghien BE 7822 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems Cepheid 510(k) NO: K161619(Traditional) ATTN: Scott A. Campbell PHONE NO : 847 2283299 904 Carribean Drive SE DECISION MADE: 29-AUG-16 Sunnyvale CA 94089-1189 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LensGiene Sterile Saline Solution Optics Laboratory, Inc. 510(k) NO: K161622(Traditional) ATTN: Patricia Chiu PHONE NO : 1 626 3501926 9480 Telstar Ave Suite 3 SE DECISION MADE: 11-AUG-16 El Monte CA 91731-2988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Thermi RF Accessories THERMI 510(k) NO: K161661(Traditional) ATTN: Carrie Eddings PHONE NO : 214 6125819 8304 ESTERS BLVD STE 890 SE DECISION MADE: 12-AUG-16 IRVING TX 75063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: sTMS mini ENEURA INC 510(k) NO: K161663(Special) ATTN: CYNTHIA MERRELL PHONE NO : 408 2456400 715 NORTH PASTORIA AVENUE SE DECISION MADE: 23-AUG-16 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYSTEM 1E Liquid Chemical Sterilant Processing System STERIS CORPORATION 510(k) NO: K161683(Special) ATTN: Tricia Cregger PHONE NO : 440 3542600 5960 HEISLEY RD SE DECISION MADE: 05-AUG-16 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Vivid iq GE MEDICAL SYSTEMS ULTRASOUND AND 510(k) NO: K161706(Traditional) ATTN: Tracey Ortiz PHONE NO : 262 6766120 9900 W. INNOVATION DR. SE DECISION MADE: 05-AUG-16 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPRIA w/guideShot Option HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K161748(Abbreviated) ATTN: DOUG THISTLETHWAITE PHONE NO : 330 4251313 1959 SUMMIT COMMERCE PARK SE DECISION MADE: 17-AUG-16 TWINSBURG OH 44087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PathLoc-L MIS Spinal System L&K BIOMED Co., Ltd. 510(k) NO: K161766(Traditional) ATTN: Yerim An PHONE NO : 82 2 67171985 #201, 202 16-25, Dongbaekjungang-rSE DECISION MADE: 22-AUG-16 Giheung-gu, Yongin-si KR 446-916 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FFRct HEARTFLOW, INC. 510(k) NO: K161772(Traditional) ATTN: Windi Hary PHONE NO : 650 2411250 1400 SEAPORT BOULEVARD BUILDING B SE DECISION MADE: 24-AUG-16 REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems Becton Dickinson Infusion Therapy 510(k) NO: K161777(Third Party - Traditional) ATTN: Kimberly Geisler PHONE NO : 801 5652422 9450 South State Street SE DECISION MADE: 29-AUG-16 Sandy UT 84070 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Aer-O-Scope Colonoscope System GI View Ltd. 510(k) NO: K161791(Traditional) ATTN: Sharon Goldfarb PHONE NO : 972 3 5753199 5 Shoham St. SE DECISION MADE: 11-AUG-16 Ramat Gan IL 5251001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FacetBRIDGE® System LDR SPINE USA, INC. 510(k) NO: K161798(Special) ATTN: JAMIE WILSON PHONE NO : 512 3443355 13785 RESEARCH BLVD SUITE 200 SE DECISION MADE: 04-AUG-16 Austin TX 78750 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARIX Foot System JEIL MEDICAL CORPORATION 510(k) NO: K161864(Traditional) ATTN: SEJIN RYU PHONE NO : 82 2 8503583 #702 KOLON SCIENCE VALLEY 2ND, 55,SE DECISION MADE: 02-AUG-16 SEOUL KR 152-728 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: On Call Pro Blood Glucose Monitoring System ACON LABORATORIES 510(k) NO: K161867(Special) ATTN: Qiyi Xie PHONE NO : 858 8758011 10125 MESA RIM ROAD SE DECISION MADE: 05-AUG-16 SAN DIEGO CA 92121 510(k) STATEMENT DEVICE: Audit MicroControls Linearity DROP LQ Blood Glucose AALTO SCIENTIFIC, LTD. 510(k) NO: K161874(Traditional) ATTN: ROBERT BURDA PHONE NO : 760 4317922 230 TECHNOLOGY PARKWAY SE DECISION MADE: 10-AUG-16 EATONTON GA 30642 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super Pl FIRST QUALITY HYGIENIC, INC. 510(k) NO: K161877(Third Party - Special) ATTN: Melanie Leibowitz PHONE NO : 516 4983665 121 NORTH RD. SE DECISION MADE: 05-AUG-16 McElhattan PA 17748 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Biomet Microfixation Sternal Closure System BIOMET MICROFIXATION 510(k) NO: K161896(Special) ATTN: LAUREN JASPER PHONE NO : 904 7419259 1520 TRADEPORT DRIVE SE DECISION MADE: 02-AUG-16 JACKSONVILLE FL 32218 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Genesys Spine TiLock Cortical Spinal System Genesys Spine 510(k) NO: K161914(Special) ATTN: William W. Sowers PHONE NO : 512 3817080 1250 Capital of Texas of Highway SSE DECISION MADE: 09-AUG-16 Austin TX 78746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: The Braun ThermoScan® 3 High Speed Compact Ear Thermometer Kaz USA, Inc., A Helen of Troy Com510(k) NO: K161933(Special) ATTN: AMY LIU PHONE NO : 508 4907240 400 DONALD LYNCH BLVD., SUITE 300 SE DECISION MADE: 16-AUG-16 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 5D Viewer SAMSUNG Medison Co., Ltd. 510(k) NO: K161955(Third Party - Traditional) ATTN: Kyeong-Mi Park PHONE NO : 82 2 21941373 42, Teheran-ro 108-gil Gagnam-gu SE DECISION MADE: 10-AUG-16 Seoul KR 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Steerable Guide Catheter ABBOTT VASCULAR 510(k) NO: K161985(Special) ATTN: Makena Mc Gowan PHONE NO : 408 8450937 3200 LAKESIDE DRIVE SE DECISION MADE: 07-AUG-16 Santa Clara CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIDEKICK and USHER Support Catheters BARD PERIPHERAL VASCULAR, INC. 510(k) NO: K161986(Special) ATTN: Melanie Hadlock PHONE NO : 480 3506083 1625 WEST 3RD STREET SE DECISION MADE: 04-AUG-16 TEMPE AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 1.5T and 3.0T 16 CH GE Shoulder Coils INVIVO CORPORATION 510(k) NO: K162001(Third Party - Traditional) ATTN: KEN REVENNAUGH PHONE NO : 352 3848590 3545 SW 47TH AVE SE DECISION MADE: 31-AUG-16 GAINESVILLE FL 32608 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle SOL-MILLENNIUM MEDICAL, INC 510(k) NO: K162030(Special) ATTN: JIM BARLEY PHONE NO : 949 4333058 1735 NORTH BROWN ROAD, SUITE 120 SE DECISION MADE: 19-AUG-16 LAWRENCEVILLE GA 30043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System FUJIFILM SonoSite, Inc. 510(k) NO: K162045(Third Party - Traditional) ATTN: Jordan Grimmer PHONE NO : 425 9516984 21919 30th Drive SE SE DECISION MADE: 18-AUG-16 Bothell WA 98021-3904 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Sentinella 102, Sentinella 102 Horus GENERAL EQUIPMENT FOR MEDICAL IMAG510(k) NO: K162052(Special) ATTN: JOSE MONTES PHONE NO : 34 963 722472 EDUARDO PRIMO YUFERA, N 3 SE DECISION MADE: 18-AUG-16 VALENCIA ES 46012 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Werewolf RF20000 Controller, FLOW 50 Wand ARTHROCARE CORPORATION 510(k) NO: K162074(Special) ATTN: SHIRLEY HYINK PHONE NO : 512 8951372 7000 W. WILLIAM CANNON DRIVE SE DECISION MADE: 22-AUG-16 AUSTIN TX 78735 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NICO TRIOwand NICO Corporation 510(k) NO: K162075(Special) ATTN: Sean Spence PHONE NO : 317 6607118 115 250 East 96th Street, Suite 125 SE DECISION MADE: 11-AUG-16 Indianapolis IN 46240 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Laparoscopic Spray Applicator with Spinning Luers MICROMEDICS INC. (D/B/A NORDSON ME510(k) NO: K162077(Special) ATTN: AMY L. PETERSON PHONE NO : 651 4052182 1270 EAGAN INDUSTRIAL RD, SUITE 12SE DECISION MADE: 11-AUG-16 ST. PAUL MN 55121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RS80A Diagnostic Ultrasound System Samsung Medison Co., Ltd 510(k) NO: K162094(Third Party - Traditional) ATTN: Kyeong-Mi Park PHONE NO : 82 2 21941373 42, Teheran-ro 108-gil, Gangnam-guSE DECISION MADE: 26-AUG-16 Seoul KR 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: UreTron PF Series Probe MED-SONICS CORP. 510(k) NO: K162119(Special) ATTN: JENNIFER RAUTINE PHONE NO : 814 8996500 4960 PITTSBURGH AVENUE, SUITE A SE DECISION MADE: 29-AUG-16 ERIE PA 16509 510(k) STATEMENT DEVICE: RENASYS-G Gauze Dressing Kits with Soft Port Smith & Nephew, Inc. 510(k) NO: K162129(Special) ATTN: Laura Reynolds PHONE NO : 800 2891261 970 Lake Carillon Drive, Suite 300SE DECISION MADE: 31-AUG-16 St Petersburg FL 33716 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Erbe’s CO2 Tubing/Cap Sets Erbe USA, Inc. 510(k) NO: K162152(Special) ATTN: John Tartal PHONE NO : 770 9554400 2225 Northwest Parkway SE DECISION MADE: 31-AUG-16 Marietta GA 30067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANAX™ 5.5 Spinal System U&I Corporation 510(k) NO: K162189(Special) ATTN: Ji Yea Lee PHONE NO : 82 31 8606837 20, Sandan-ro 76beon-gil(Rd) SE DECISION MADE: 30-AUG-16 Uijeongbu-si KR 11781 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Dell UP3216Q with QUBYX PerfectLum bundle QUBYX SOFTWARE TECHNOLOGIES INC. 510(k) NO: K162196(Traditional) ATTN: MARC LEPPLA PHONE NO : 518 6181012 501 SILVERSIDE ROAD, SUITE 105 SE DECISION MADE: 15-AUG-16 WILMINGTON DE 19809 510(k) SUMMARY AVAILABLE FROM FDA
