510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD September 2018
DEVICE: mediCAD 4.0
mediCAD Hectec Gmbh 510(k) NO: K170702(Traditional)
ATTN: Claas-Fabian Luers PHONE NO : 49 871 33020315
Opalstrasse 54 SE DECISION MADE: 07-SEP-18
Altdorf DE 84032 510(k) STATEMENT
DEVICE: TruBase S
TruAbutment Inc. 510(k) NO: K171532(Traditional)
ATTN: Brandon Kim PHONE NO : 714 9561488
300 South Harbor Blvd #520 SE DECISION MADE: 11-SEP-18
Anaheim CA 92805 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tandry Locking Plate System
Microware Precision Co., Ltd. 510(k) NO: K171904(Traditional)
ATTN: Harrison Du PHONE NO : 886 4 24636275 100
No. 12, Keyuan 2nd Rd., Situn DistSE DECISION MADE: 18-SEP-18
Taichung TW 407630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLOASSIST II
AKTORmed GmbH 510(k) NO: K171947(Traditional)
ATTN: Andreas Mohr PHONE NO : 49 9401 9320150
Borsigstrabe 13 SE DECISION MADE: 21-SEP-18
Barbing DE 93092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OpenSight
Novarad Corporation 510(k) NO: K172418(Traditional)
ATTN: Doug Merrill PHONE NO : 801 6421001
752 East 1180 South #200 SE DECISION MADE: 21-SEP-18
American Fork UT 84003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENS device-HeadaTerm, eEspress
WAT Medical Technology (Ningbo) Co510(k) NO: K172450(Traditional)
ATTN: Rodney Zhang PHONE NO : 86 574 65060811
Room703-711, No.2 North Taoyuan RoSE DECISION MADE: 13-SEP-18
Ningbo CN 315600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dual output digital therapy massager
Shenzhen OSTO Technology Co., Ltd.510(k) NO: K172834(Traditional)
ATTN: Li Yang PHONE NO : 86 755 29769546
No.43 Longfeng Road, Xinsheng CommSE DECISION MADE: 06-SEP-18
Shenzhen CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kawasumi Laboratories Blood Drawing Kit (BDK) System
Kawasumi Laboratories, Inc. 510(k) NO: K172957(Traditional)
ATTN: Takayuki Nakajima PHONE NO : 81 3 57692663
Shinagawa Intercity Tower B, 9th FSE DECISION MADE: 28-SEP-18
Tokyo JP 108-6109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)
Skyla Corporation H.S.P.B. 510(k) NO: K173127(Traditional)
ATTN: Cindy Lu PHONE NO : 886 3 5787722 5829
1f. No. 8, Dusing Rd., Hsinchu SciSE DECISION MADE: 25-SEP-18
Hsinchu TW 30078 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CSM Submerged3-L Implant System
CSM Implant 510(k) NO: K173141(Traditional)
ATTN: Sung Am Cho PHONE NO : 82 53 9528261
B205 Techno B/D, 47 Gyeongdae-ro, SE DECISION MADE: 19-SEP-18
Daegu KR 41566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioSphere Flex
Synergy Biomedical 510(k) NO: K173424(Traditional)
ATTN: Mark Borden PHONE NO : 484 9028141
100 Springhouse Dr. Suite 108 SE DECISION MADE: 12-SEP-18
Collegeville PA 19426 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeoBase 2 Non-derivatized MSMS Kit
Wallac Oy, Subsidiary of PerkinElm510(k) NO: K173568(Traditional)
ATTN: Brian Carney PHONE NO : 781 6635651
940 Winter Street SE DECISION MADE: 04-SEP-18
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMSafe Sure-Lok Needle-Free Connector
Amsino International, Inc. 510(k) NO: K173665(Traditional)
ATTN: Cathy Hong PHONE NO : 909 6265888
708 Corporate Center Drive SE DECISION MADE: 05-SEP-18
Pomona CA 91768 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A-FIT
HIRONIC Co., Ltd. 510(k) NO: K173676(Traditional)
ATTN: Sangwon Hwang PHONE NO : 82 31 5257400
19F, 767, Sinsu-ro, Suji-gu SE DECISION MADE: 14-SEP-18
Gyeonggi-do KR 16827 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surveyor Patient Monitor
Mortara Instrument, Inc. 510(k) NO: K173765(Traditional)
ATTN: Manisha Gokuli PHONE NO : 414 3541600
7865 North 86th Street SE DECISION MADE: 04-SEP-18
Milwaukee WI 53224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Hair Removal Device Joy Version
Shen Zhen CosBeauty Co., Ltd 510(k) NO: K173813(Traditional)
ATTN: Nicole Hu PHONE NO : 86 1831 6858036
UnitA-3F, Qiao De Industrial Park,SE DECISION MADE: 07-SEP-18
Shenzhen CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anchor Tissue Retrieval System by CONMED
Conmed Corporation 510(k) NO: K173822(Traditional)
ATTN: Rachelle D Fitzgerald PHONE NO : 516 2364060
525 French Road SE DECISION MADE: 11-SEP-18
Utica NY 13502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LightScalpel
LightScalpel LLC 510(k) NO: K173827(Traditional)
ATTN: David Walters PHONE NO : 425 3681588
11818 North Creek Parkway N Suite SE DECISION MADE: 14-SEP-18
Bothell WA 98011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAC VU360 Resting ECG Analysis System
GE Medical Systems Information Tec510(k) NO: K173830(Traditional)
ATTN: Marcella Entwisle PHONE NO : 414 7213809
9900 West Innovation Drive SE DECISION MADE: 18-SEP-18
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRP Vario
SENTINEL CH. SpA 510(k) NO: K173833(Traditional)
ATTN: Patricia Dupe PHONE NO : 39 02 34551496
Via Robert Koch 2 SE DECISION MADE: 27-SEP-18
Milano IT 20152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres
Suzhou Hengrui Callisyn Biomedical510(k) NO: K173871(Traditional)
ATTN: Xiao Chen PHONE NO : 86 512 68050607
Buliding 9, No. 8 Jinfeng Road, NeSE DECISION MADE: 17-SEP-18
Suzhou CN 215163 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FibriCheck
Qompium nv 510(k) NO: K173872(Traditional)
ATTN: Jo Van der Auwera PHONE NO : 32 479 393153
Kempische Steenweg 311/27 SE DECISION MADE: 28-SEP-18
Hasselt BE 3500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: External Fixation System
Life Spine Inc. 510(k) NO: K173883(Traditional)
ATTN: Randy Lewis PHONE NO : 847 8846117
13951 S Quality Drive SE DECISION MADE: 07-SEP-18
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Trabis
coLigne, AG 510(k) NO: K173893(Traditional)
ATTN: Robert Lange PHONE NO : 41 43 3438000
Utoquai 43 SE DECISION MADE: 06-SEP-18
Zurich CH CH 8008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MicroPort Orthopedics Total Hip Systems MR Labeling
MicroPort Orthopedics Inc. (MPO) 510(k) NO: K173898(Traditional)
ATTN: Usman Rashid PHONE NO : 901 2905274
5677 Airline Road SE DECISION MADE: 20-SEP-18
Arlington TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Impress SFS System
Cable Fix Medical LLC 510(k) NO: K173910(Traditional)
ATTN: Carey Bryant PHONE NO : 901 5528088
1050 Getwell Road S SE DECISION MADE: 14-SEP-18
Hernando MS 38632 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HD-500 Video Endoscope System
Sonoscape Medical Corp. 510(k) NO: K173921(Traditional)
ATTN: Toki Wu PHONE NO : 86 755 26722890
4/f, 5/f, 8/f, 9/f & 10/f Yizhe buSE DECISION MADE: 05-SEP-18
Shenzhen CN 518051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DORADOnova MR3T
LAP GmbH Laser Applikationen 510(k) NO: K173926(Traditional)
ATTN: Martin Pfabel PHONE NO : 49 4131 9511267
Zeppelinstrasse 23 SE DECISION MADE: 14-SEP-18
Lueneburg DE 21337 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sorrento Bioglass Bone Graft Substitute
Xenco Medical, LLC 510(k) NO: K173933(Traditional)
ATTN: Michelle Willis PHONE NO : 858 2021505
9930 Mesa Rim Road SE DECISION MADE: 13-SEP-18
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IntelliSpace Perinatal Rev.K.00
Philips Medizin Systeme Boeblingen510(k) NO: K173941(Traditional)
ATTN: Christoph Krause PHONE NO : 49 7031 4631734
Hewlett-Packard-Str.-2 SE DECISION MADE: 10-SEP-18
Boeblingen DE 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DePuy Corail AMT Hip Prosthesis
DePuy France S.A.S. 510(k) NO: K173960(Traditional)
ATTN: David Holzwarth PHONE NO :
7 Allee Irene Joliot Curie Bp256 SE DECISION MADE: 21-SEP-18
Saint Priest Cedex Rhone-Alpes FR510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Masimo Acoustic Respiration Sensors, infant and neonate
Masimo Corporation 510(k) NO: K173976(Abbreviated)
ATTN: Karina Simpson PHONE NO : 949 2977387
52 Discovery SE DECISION MADE: 05-SEP-18
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORTIFY Corpectomy Spacers
Globus Medical Inc. 510(k) NO: K173982(Traditional)
ATTN: Lori Burns PHONE NO : 610 9301800 2950
2560 General Armistead Ave. SE DECISION MADE: 19-SEP-18
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Malecot Nephrostomy Catheter/Stent Set
Cook Incorporated 510(k) NO: K180029(Traditional)
ATTN: Minjin Choi PHONE NO : 812 3392235 104901
750 Daniels Way SE DECISION MADE: 21-SEP-18
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioCode Gastrointestinal Pathogen Panel (GPP)
Applied Biocode, Inc. 510(k) NO: K180041(Traditional)
ATTN: Robert Di Tullio PHONE NO : 562 8010050
10020 Pioneer Blvd. Suite 102 SE DECISION MADE: 28-SEP-18
Santa Fe Springs CA 90670 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sof-Flex Ureteral Stent Set
Cook Incorporated 510(k) NO: K180053(Traditional)
ATTN: Minjin Choi PHONE NO : 812 3392235 104901
750 Daniels Way SE DECISION MADE: 13-SEP-18
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORISE Gel
Boston Scientific 510(k) NO: K180068(Traditional)
ATTN: Thomas Hirte PHONE NO : 508 6834454
100 Boston Scientific Way SE DECISION MADE: 28-SEP-18
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Agile Esophageal Stent System
Boston Scientific Corporation 510(k) NO: K180144(Traditional)
ATTN: Kayla Mackey PHONE NO : 508 6834534
100 Boston Scientific Way SE DECISION MADE: 21-SEP-18
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Guidewire
Shanghai Kindly Medical Instrument510(k) NO: K180177(Traditional)
ATTN: Xu Jianhai PHONE NO : 086 021 59140056 8870
No. 925, Jinyuan yi Road SE DECISION MADE: 13-SEP-18
Shanghai CN 201803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Introducer Set
Shanghai Kindly Medical Instrument510(k) NO: K180178(Traditional)
ATTN: Xu Jianhai PHONE NO : 086 021591 400568870
No. 925, Jinyuan yi Road SE DECISION MADE: 10-SEP-18
Shanghai CN 201803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter
Cook Incorporated 510(k) NO: K180182(Traditional)
ATTN: Samuel Engelman PHONE NO : 812 3392235 104340
750 Daniels Way SE DECISION MADE: 14-SEP-18
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNA-LINK ELITE Stand-Alone Anterior Lumbar System
Life Spine Inc. 510(k) NO: K180215(Traditional)
ATTN: Randy Lewis PHONE NO : 847 8846117
13951 S Quality Drive SE DECISION MADE: 13-SEP-18
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Seidmon Antegrade AQ Stent Set
Cook Incorporated 510(k) NO: K180216(Traditional)
ATTN: Rebecca Odulio (Li-Chun-LiuPHONE NO : 812 3353575 104673
750 Daniels Way P.O. Box 489 SE DECISION MADE: 28-SEP-18
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Orthocaps Twinaligner
Ortho Caps GmbH 510(k) NO: K180241(Traditional)
ATTN: Wajeeh Khan PHONE NO : 49 0 23859219 0
An der Bewer 8 SE DECISION MADE: 28-SEP-18
Hamm 59069 DE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cellulize
Ward Photonics LLC 510(k) NO: K180338(Traditional)
ATTN: Terry Ward PHONE NO : 800 3925950
1980 N Atlantic Avenue SE DECISION MADE: 21-SEP-18
Cocoa Beach FL 32931 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stat Profile Prime Plus Analyzer System
Nova Biomedical Corporation 510(k) NO: K180340(Traditional)
ATTN: Adam Heroux PHONE NO : 781 8940800
200 Prospect St. SE DECISION MADE: 26-SEP-18
Waltham MA 02454 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EndoTool SubQ
Monarch Medical Technologies, Inc.510(k) NO: K180366(Traditional)
ATTN: Linda Beneze PHONE NO : 704 3231300
2137 South Blvd Suite 300 SE DECISION MADE: 20-SEP-18
Charlotte NC 28203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)
Relievant Medsystems 510(k) NO: K180369(Traditional)
ATTN: Alex DiNello PHONE NO : 650 3681000
385 Moffett Park Drive, Suite 105 SE DECISION MADE: 14-SEP-18
Sunnyvale CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Provata Implant System
Southern Implants (Pty) Ltd 510(k) NO: K180465(Traditional)
ATTN: Lauranda G. Breytenbach PHONE NO : 27 12 6671046
1 Albert Road SE DECISION MADE: 06-SEP-18
Irene ZA 0062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEVADAPTOR Closed Drug Reconstitution and Transfer System
Teva Medical Ltd., Migada Plant 510(k) NO: K180489(Traditional)
ATTN: Nadav Reuben PHONE NO : 972 4 6908826
North Industrial Zone SE DECISION MADE: 21-SEP-18
Kiryat Shmona IL 10258 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Probe Covers for Thermometers
K-jump Health Co., Ltd. 510(k) NO: K180714(Abbreviated)
ATTN: JM Lin PHONE NO : 886 2 22991378
No. 56, Wu Kung 5th Rd. New TaipeiSE DECISION MADE: 24-SEP-18
New Taipei City TW 24890 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spinal Elements Cerclage System
Spinal Elements Inc 510(k) NO: K180728(Traditional)
ATTN: Julie Lamothe PHONE NO : 760 6071816
3115 Melrose Dr., Suite 200 SE DECISION MADE: 06-SEP-18
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exceed Microneedling Device
MT.DERM GmbH 510(k) NO: K180778(Traditional)
ATTN: Anderas Pachten PHONE NO : 49 30 8458854
Gustav-Krone-Str.3 SE DECISION MADE: 07-SEP-18
Berlin DE 14167 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bard Vertus Foley Catheter
C. R. Bard, Inc. 510(k) NO: K180781(Traditional)
ATTN: Sharon Lambert PHONE NO : 770 7846208
8195 Industrial Blvd. SE DECISION MADE: 19-SEP-18
Covington GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BeautiBond Universal
Shofu Dental Corporation 510(k) NO: K180803(Traditional)
ATTN: Mauro Malzyner PHONE NO : 760 7363277
1225 Stone Drive SE DECISION MADE: 26-SEP-18
San Marcos CA 92078 510(k) STATEMENT
DEVICE: Portable Nebulizer
MicroBase Technology Corporation 510(k) NO: K180871(Traditional)
ATTN: Molly Hsieh PHONE NO : 011 886 33767555
No. 756, Jiadong Road SE DECISION MADE: 14-SEP-18
Bade District, Taoyuan City TW 33510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLY REJUV
Medtek Skincare, LLC 510(k) NO: K180875(Traditional)
ATTN: Gary Richardson PHONE NO : 518 7473310
3 Depot Street SE DECISION MADE: 14-SEP-18
Hudson Falls NY 12839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IHM Technology Bandage
Protege Biomedical 510(k) NO: K180893(Traditional)
ATTN: Mike Corcoran PHONE NO : 612 2262915
10909 Valley View Rd. SE DECISION MADE: 19-SEP-18
Eden Prairie MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Magnetic Surgical System
Levita Magnetics International Cor510(k) NO: K180894(Traditional)
ATTN: Alberto Rodrigues-Navarro PHONE NO : 650 2410320
1730 S. Amphlett Blvd, Suite 240 SE DECISION MADE: 19-SEP-18
San Mateo CA 94402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iNtuition-T1 Mapping and T2/T2* Mapping
TeraRecon Inc., 510(k) NO: K180916(Traditional)
ATTN: Megha Jain PHONE NO : 650 3721100
4000 East 3rd Avenue, Suite 200 SE DECISION MADE: 24-SEP-18
Foster City CA 94404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DenTek Ultimate Dental Guard
Medtech Products Inc. 510(k) NO: K180933(Traditional)
ATTN: Mary Beth Fritz PHONE NO : 914 5246842
660 White Plains Rd Suite 250 SE DECISION MADE: 17-SEP-18
Tarrytown NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endoscope Sterilization Tray
Intuitive Surgical, Inc. 510(k) NO: K180964(Traditional)
ATTN: Kunal Gunjal PHONE NO : 408 5238017
1266 Kifer Road, Building 101 SE DECISION MADE: 28-SEP-18
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Libertas Hip Replacement System
Maxx Orthopedics, Inc 510(k) NO: K180973(Traditional)
ATTN: Corey Perine PHONE NO : 484 3420092
531 Plymouth Road, Suite 526 SE DECISION MADE: 28-SEP-18
Plymouth Meeting PA 19462 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit
Stimwave Technologies Incorporated510(k) NO: K180981(Traditional)
ATTN: Elizabeth Greene PHONE NO : 1 800 9655134
1310 Park Central Boulevard South SE DECISION MADE: 19-SEP-18
Pompano Beach FL 33064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioHorizons CAD/CAM Bars
BioHorizons Implant Systems, Inc. 510(k) NO: K180998(Traditional)
ATTN: Michael Davis PHONE NO : 205 9677880
2300 Riverchase Center SE DECISION MADE: 28-SEP-18
Birmingham AL 35244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SelectFlex 072 Neurovascular Access System
Q'Apel 510(k) NO: K181000(Traditional)
ATTN: Ken Peartree PHONE NO : 310 3953950
330 Wilshire Boulevard SE DECISION MADE: 13-SEP-18
Santa Monica CA 90401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BB-613 Watch Oximeter
Bio-Beat Technologies Ltd. 510(k) NO: K181006(Traditional)
ATTN: Johanan May PHONE NO : 972 3 9333022
26 Magshimim Street SE DECISION MADE: 21-SEP-18
Petach Tikvah IL 4934835 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EmboCube Embolization Gelatin
Biosphere Medical, S.A. 510(k) NO: K181021(Traditional)
ATTN: Alix Fonlladosa PHONE NO : 33 1 48172529
Parc des Nations – Paris Nord 2, 3SE DECISION MADE: 27-SEP-18
Roissy en France FR 95700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pocket Colposcope System
Hadleigh Health Technologies, LLC 510(k) NO: K181034(Traditional)
ATTN: Robert Miros PHONE NO : 415 4543005 1003
30 Castro Ave. SE DECISION MADE: 21-SEP-18
San Rafael CA 94901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Corin Optimized Positioning System (OPS) Femoral
Corin USA 510(k) NO: K181061(Traditional)
ATTN: Lucinda Gerber PHONE NO : 1 813 9774469
12750 Citrus Park Lane, Suite 120 SE DECISION MADE: 07-SEP-18
Tampa FL 33625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims
ECO Medi Glove Sdn Bhd 510(k) NO: K181066(Traditional)
ATTN: Suresh Kumar PHONE NO : 605 8912777
Lot 23826, Jalan Tembaga Kuning KaSE DECISION MADE: 26-SEP-18
Perak MY 34600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PureSet Tray
Nobel Biocare AB 510(k) NO: K181075(Traditional)
ATTN: Charlemagne Chua PHONE NO : 714 2824800 7830
BOX 5190, SE-402 26, Vastra HamngaSE DECISION MADE: 27-SEP-18
Goteborg SE SE-411 17 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The Sex Gel
Necessaire, Inc. 510(k) NO: K181078(Traditional)
ATTN: Randi Christiansen Stanley PHONE NO : 512 5605750
10 Arbolo Court SE DECISION MADE: 10-SEP-18
Manhattan Beach CA 90266 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TSP Crosser Transseptal Access System
Transseptal Solutions Ltd. 510(k) NO: K181088(Traditional)
ATTN: Mary P. LeGraw PHONE NO : 508 6917038
10 HaGavish St., P.O. Box 4060 SE DECISION MADE: 28-SEP-18
Natanya IL 4250708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ThermaCare Quick Therapy TENS
Pfizer Inc. 510(k) NO: K181102(Traditional)
ATTN: Nicola Romano PHONE NO : 973 6605858
235 East 42nd Street SE DECISION MADE: 15-SEP-18
New York NY 10017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acessa ProVu System
Acessa Health, Inc. 510(k) NO: K181124(Traditional)
ATTN: Brian J. Bergeron PHONE NO : 508 7351590
7004 Bee Cave Road, Bldg 3, Suite SE DECISION MADE: 28-SEP-18
Austin TX 78746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)
Contego Medical, LLC 510(k) NO: K181128(Traditional)
ATTN: Elizabeth Saylors PHONE NO :
3921 Sunset Ridge Rd, Suite 102 SE DECISION MADE: 06-SEP-18
Raliegh NC 27607 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Upcera Glaze Paste, Glaze Powder, and Glaze Liquid
Liaoning Upcera Co., Ltd 510(k) NO: K181167(Traditional)
ATTN: Charles Shen PHONE NO : 086 24 45565006
No.122 Xianghuai Road, Economic DeSE DECISION MADE: 02-SEP-18
Benxi CN 117004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Katalyst Mark 1 Muscle Stimulation System Model 2
Katalyst Inc. 510(k) NO: K181199(Traditional)
ATTN: Bjoern Woltermann PHONE NO : 206 4883939
316 Occidental Ave. South Suite B3SE DECISION MADE: 20-SEP-18
Seattle WA 98104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEROmini Tracheobronchial Stent System
Merit Medical Systems, Inc 510(k) NO: K181200(Traditional)
ATTN: David Thomas PHONE NO : 801 3164956
1600 West Merit Parkway SE DECISION MADE: 21-SEP-18
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
Centers for Disease Control and Pr510(k) NO: K181205(Traditional)
ATTN: Yon Yu PHONE NO : 404 6393046
1600 Clifton Road NE, MS-C18 SE DECISION MADE: 20-SEP-18
Atlanta GA 30329 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Human Tecar HCR 1002
UNIBELL S.r.l 510(k) NO: K181211(Traditional)
ATTN: Mario Scerri PHONE NO : 39 039991131
Via Indipendenza, 27 SE DECISION MADE: 10-SEP-18
Calco IT 23885 510(k) STATEMENT
DEVICE: TirboLOX-C Cervical IBFD
Captiva Spine, Inc. 510(k) NO: K181229(Traditional)
ATTN: Jackie Ferro PHONE NO : 877 7725571 719
967 N. Alternate A1A, Ste. 1 SE DECISION MADE: 19-SEP-18
Jupiter FL 33477 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elecsys FT4 III
Roche Diagnostics 510(k) NO: K181233(Traditional)
ATTN: Reanna Toney PHONE NO : 317 5214516
9115 Hague Road SE DECISION MADE: 18-SEP-18
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HySil Impression Materials
OSSTEM IMPLANT CO LTD 510(k) NO: K181236(Traditional)
ATTN: Jungmin Yoo PHONE NO : 82 51 8502575
203, GEOJE-DAERO YEONJE-GU SE DECISION MADE: 13-SEP-18
BUSAN KR 611-804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLS Martin Individual Patient Solutions (IPS) Planning System
KLS-Martin L.P. 510(k) NO: K181241(Traditional)
ATTN: Jennifer Damato PHONE NO : 800 6251557
11201 Saint Johns Industrial Pkwy SE DECISION MADE: 13-SEP-18
Jacksonville FL 32246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EUSRA RF Electrode
STARmed Co., Ltd. 510(k) NO: K181249(Traditional)
ATTN: Jun-Young Jung PHONE NO : 82 70 46738657
B-dong, 4F, 158, Haneulmaeul-ro, ISE DECISION MADE: 04-SEP-18
Goyang-si KR 10355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRODENSE Bone Graft Substitute
Wright Medical Technology, Inc. 510(k) NO: K181255(Traditional)
ATTN: Rachel Roberts PHONE NO : 901 8679708
1023 Cherry Road SE DECISION MADE: 12-SEP-18
Memphis TN 37117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable SpO2 Sensors, Reusable SpO2 Sensors
Orantech Inc. 510(k) NO: K181270(Traditional)
ATTN: Yunxi Xiong PHONE NO : 86 075 523699939
Zone#A, 4F, 1st Bld, 7th IndustriaSE DECISION MADE: 07-SEP-18
Shenzhen CN 518132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-CUBE 12
Alpinion Medical Systems Co., Ltd.510(k) NO: K181277(Traditional)
ATTN: Boyeon Cho PHONE NO : 82 707 4652104
1FL and 6FL, Verdi Tower, 72, DigiSE DECISION MADE: 28-SEP-18
Seoul KR 08393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OralTox Oral fluid Drug Test
Premier Biotech, Inc. 510(k) NO: K181305(Traditional)
ATTN: Jacqueline Gale PHONE NO : 612 8395563
723 Kasota Avenue SE SE DECISION MADE: 20-SEP-18
Minneapolis MN 55414 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Philips Hemodynamic Application R1.0
Philips Medical Systems Nederlands510(k) NO: K181311(Abbreviated)
ATTN: Owen Callaghan PHONE NO : 31 621 394159
Veenpluis 4-6 SE DECISION MADE: 07-SEP-18
Best NL 5684PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension
Philips Medizin Systeme Boeblingen510(k) NO: K181314(Traditional)
ATTN: Stefan Breuer PHONE NO : 49 7031 4632321
Hewlett-Packard-Str. 2 SE DECISION MADE: 04-SEP-18
Boeblingen DE 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Caprolon
Resorba Medical GmbH 510(k) NO: K181320(Traditional)
ATTN: Helen Topping PHONE NO : 49 9128 91150
Am Flachmoor 16 SE DECISION MADE: 18-SEP-18
Nuremberg DE 90475 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T2 STRATOSPHERE™ Expandable Corpectomy System
Medtronic Sofamor Danek, USA Inc. 510(k) NO: K181328(Traditional)
ATTN: Kanesha Hines PHONE NO : 901 3992670
1800 Pyramid Place SE DECISION MADE: 19-SEP-18
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sypher Spacer System
Biogennix, LLC 510(k) NO: K181337(Traditional)
ATTN: Tim Bumbalough PHONE NO : 949 2530994
18007 Sky Park Circle, Suite f SE DECISION MADE: 18-SEP-18
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens
Visco Vision Inc 510(k) NO: K181349(Traditional)
ATTN: Evan Huang PHONE NO : 886 3 3596868
No. 1, Xingye St., Guishan Dist., SE DECISION MADE: 19-SEP-18
Taoyuan City TW 33341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REDAPT Porous Acetabular Shell
Smith & Nephew, Inc. 510(k) NO: K181366(Traditional)
ATTN: Bryan Cowell PHONE NO : 978 7491093
7135 Goodlett Farms Parkway SE DECISION MADE: 24-SEP-18
Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LnK Lumbar Interbody Fusion Cage System
L&K BIOMED Co., Ltd. 510(k) NO: K181380(Traditional)
ATTN: Jihyeon Seo PHONE NO : 82 2 67171983
#201, 202, 16-25, Dongbaekjungang-SE DECISION MADE: 11-SEP-18
Yongin-si KR 17015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System
OrthoPediatrics, Corp 510(k) NO: K181390(Traditional)
ATTN: Mark Fox PHONE NO : 574 2686379
2850 Frontier Drive SE DECISION MADE: 18-SEP-18
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DualX
Innovasive, Inc. 510(k) NO: K181397(Traditional)
ATTN: Andy Choi PHONE NO : 949 6984854
26020 Acero, Ste 200 SE DECISION MADE: 27-SEP-18
Mission Viejo CA 92691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0
Canon Medical Systems Corporation 510(k) NO: K181415(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 10-SEP-18
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aequalis Flex Revive Shoulder System
Tornier, Inc. 510(k) NO: K181420(Traditional)
ATTN: Laurie Lewandowski PHONE NO : 612 7704038
10801 Nesbitt Ave South SE DECISION MADE: 20-SEP-18
Bloomington MN 55437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMSure Sterile Water, and Sterile Normal Saline for Wound Flush
Amsino International Inc. 510(k) NO: K181423(Traditional)
ATTN: Jane Gao PHONE NO : 909 6265888
708 Corporate Center Drive SE DECISION MADE: 07-SEP-18
Pomona CA 91768 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PeDIA
PeDIA, LLC 510(k) NO: K181424(Traditional)
ATTN: Diane Miller PHONE NO : 703 9669578
2804 Albany Court SE DECISION MADE: 25-SEP-18
Fairfax VA 22031 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ortoma Treatment Solution - OTS
Ortoma AB 510(k) NO: K181449(Traditional)
ATTN: Linus Bystrom PHONE NO : 46 73 8103660
Vadursgatan 5 SE DECISION MADE: 19-SEP-18
Goteborg SE S-41250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProSun sunlamp products, Luxura sunlamp products
ProSun International LLC 510(k) NO: K181455(Traditional)
ATTN: Tom Henkemans PHONE NO : 727 8250400
2442 23rd Street North SE DECISION MADE: 10-SEP-18
Saint Petersburg FL 33713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cadwell Zenith System
Cadwell Industries, Inc. 510(k) NO: K181466(Traditional)
ATTN: Alison Hull PHONE NO : 800 2453001 210
909 North Kellogg Street SE DECISION MADE: 01-SEP-18
Kennewick WA 99336 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Prime&Bond active Universal Adhesive
Dentsply Sirona 510(k) NO: K181476(Traditional)
ATTN: Karl Nittinger PHONE NO : 717 8494424
221 West Philadelphia Street, SuitSE DECISION MADE: 28-SEP-18
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker Pediatric Mandibular Distractor 2
Stryker 510(k) NO: K181504(Traditional)
ATTN: Gregory Gohl PHONE NO : 269 3894319
750 Trade Centre Way - Suite 200 SE DECISION MADE: 11-SEP-18
Portage MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHOLASER X4
El.En Electronic Engineering Spa 510(k) NO: K181510(Traditional)
ATTN: Paolo Peruzzi PHONE NO : 39 0558826807
Via Baldanzese 17 SE DECISION MADE: 04-SEP-18
Calenzano IT 50041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sebacia Microparticles
Sebacia, Inc. 510(k) NO: K181518(Traditional)
ATTN: Todd J. Meyer PHONE NO : 678 8121150
2905 Premiere Parkway, Suite 150 SE DECISION MADE: 06-SEP-18
Duluth GA 30097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INNOVANCE Free PS Ag
Siemens Healthcare Diagnostics Pro510(k) NO: K181525(Traditional)
ATTN: Petra Dissmann PHONE NO : 49 172 3692459
Emil-von-Behring Strasse 76 SE DECISION MADE: 07-SEP-18
Marburg DE 35041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exactech Alteon Monobloc Revision Stem
Exactech, Inc. 510(k) NO: K181532(Special)
ATTN: Zach Sharrah PHONE NO : 352 3771140
2320 NW 66th Court SE DECISION MADE: 04-SEP-18
Gainesville FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLOW800
Leica Microsystems (Schweiz) AG 510(k) NO: K181537(Traditional)
ATTN: Georges Hakim PHONE NO : 41 71 7263245
Max Schmidheiny-Strasse 201 SE DECISION MADE: 07-SEP-18
Heerbrugg CH 9435 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens
Gelflex Laboratories 510(k) NO: K181558(Traditional)
ATTN: David Masel PHONE NO : 61 8 94434944
52 Mulgul Road SE DECISION MADE: 06-SEP-18
Malaga AU 6090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology
Access Scientific, LLC 510(k) NO: K181563(Traditional)
ATTN: Martina Nguyen PHONE NO : 858 2598333
3910 Sorrento Valley Boulevard, SuSE DECISION MADE: 26-SEP-18
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Salon Hair Reduction System
Medical Device Branch of Zhangzhou510(k) NO: K181568(Traditional)
ATTN: Bruce Wu PHONE NO : 86 1366 6097743
4th Floor of Building #1, No.228, SE DECISION MADE: 11-SEP-18
Zhangzhou CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Planmeca Viso
Planmeca Oy 510(k) NO: K181576(Traditional)
ATTN: Lars Moring PHONE NO : 358 20 7795500
Asentajankatu 6 SE DECISION MADE: 13-SEP-18
Helsinki FI 00880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fixated Asfora BULLET CAGE® (FABC)
Medical Designs, LLC 510(k) NO: K181591(Traditional)
ATTN: Kristi Vondra PHONE NO : 605 2751032
6709 S. Minnesota Ave, Suite 204 SE DECISION MADE: 26-SEP-18
Sioux Falls SD 57108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spectralis HRA+OCT and variants with OCT Angiography Module
Heidelberg Engineering GmbH 510(k) NO: K181594(Traditional)
ATTN: Christoph Schoess PHONE NO : 49 6221 64630
Max-Jarecki-Strasse 8 SE DECISION MADE: 13-SEP-18
Heidelberg DE 69115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Prime E-CLASS XLPE Liner
MicroPort Orthopedics Inc. 510(k) NO: K181598(Traditional)
ATTN: Sarah Evonne Stroupe PHONE NO : 901 2905165
5677 Airline Road SE DECISION MADE: 14-SEP-18
Arlington TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Standard Clamp
Standard Bariatrics 510(k) NO: K181608(Traditional)
ATTN: Alison Sathe PHONE NO : 513 3047971
4362 Glendale Milford Rd. SE DECISION MADE: 27-SEP-18
Cincinnati OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Comprehensive Reverse Shoulder System
Biomet Manufacturing Corp 510(k) NO: K181611(Traditional)
ATTN: Dalene Binkley PHONE NO : 574 3726789
56 East Bell Drive SE DECISION MADE: 24-SEP-18
Warsaw IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PSM 3-Way Silicone Foley Catheter
Pathway, LLC 510(k) NO: K181616(Traditional)
ATTN: David Stroup PHONE NO : 619 4150103 701
8779 Cottonwood Avenue, Suite 105 SE DECISION MADE: 21-SEP-18
Santee CA 92071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endoscopic Linear Cutting Staplers and Loading Units for Single Use
Ezisurg (Suzhou) Medical Co., Ltd.510(k) NO: K181620(Traditional)
ATTN: Renjing Tian PHONE NO : 86 21 50456176 8026
Building 16, No. 8 Jinfeng Rd., SuSE DECISION MADE: 18-SEP-18
Suzhou CN 215163 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Venacure 1470 Pro
Quanta System Spa 510(k) NO: K181632(Traditional)
ATTN: Francesco Dell'Antonio PHONE NO : 39 0331 376797
Via Acquedotto 109 SE DECISION MADE: 17-SEP-18
Samarate (Va) IT 21017 510(k) STATEMENT
DEVICE: Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture
Ethicon, Inc. 510(k) NO: K181652(Traditional)
ATTN: Donna Marshall PHONE NO : 908 5413990
Route 22 West, P.O. Box 151 SE DECISION MADE: 28-SEP-18
Somerville NJ 08876-0151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed
Ethicon Endo-Surgery, LLC 510(k) NO: K181653(Traditional)
ATTN: Sigfrido Delgado PHONE NO : 787 2726144
475 Calle C SE DECISION MADE: 18-SEP-18
Guaynabo PR 00969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Renovis S180 Lateral Lumbar Interbody Fusion System
Renovis Surgical Technologies 510(k) NO: K181655(Traditional)
ATTN: Anthony Debenedictis PHONE NO : 909 5572360
1901 W. Lugonia SE DECISION MADE: 11-SEP-18
Redlands CA 92374 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Iridex TruFocus LIO Premiere
Iridex Corporation 510(k) NO: K181662(Special)
ATTN: Edward J. Sinclair PHONE NO : 650 2189149
1212 Terra Bella Avenue SE DECISION MADE: 05-SEP-18
Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN
Becton,Dickinson and Company 510(k) NO: K181665(Traditional)
ATTN: Monica E. Giguere PHONE NO : 410 3164287
7 Loveton Circle MC 694 SE DECISION MADE: 21-SEP-18
Sparks MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator
Shenzhen Roundwhale Technology Co.510(k) NO: K181688(Traditional)
ATTN: Kevin Zhang PHONE NO : 86 755 23212776
No. 615, Building C of Sanlian IndSE DECISION MADE: 07-SEP-18
Shenzhen CN 518108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag Applicator (10 pack), 7cm Tag Applicator (10 pack), 10cm Tag Applicator (10 pack), LOCalizer Surgical Probe, LOCalizer Surgical Probe (5 pack)
Health Beacons, Inc. 510(k) NO: K181692(Traditional)
ATTN: Nancy Confrey PHONE NO : 978 2874635
34 Walden St., #753 SE DECISION MADE: 25-SEP-18
Concord MA 01742 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tranquil-L Interbody System
Nexus Spine, LLC 510(k) NO: K181702(Traditional)
ATTN: Jared Crocker PHONE NO : 801 7028342
2825 E Cottonwood Parkway, Suite 3SE DECISION MADE: 21-SEP-18
Salt Lake City UT 84121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Everyway Wireless TENS & EMS Unit
Everyway Medical Instruments Co., 510(k) NO: K181707(Traditional)
ATTN: Paul Hung PHONE NO : 886 2 26620038
3Fl., No. 5, Lane 155, Section 3, SE DECISION MADE: 26-SEP-18
Shenkeng District, New Taipei City510(k) STATEMENT
DEVICE: Ceracell Ortho Foam
curasan AG 510(k) NO: K181721(Traditional)
ATTN: Gregor Thomas PHONE NO : 49 6027 409000
Lindigstrasse 4 SE DECISION MADE: 17-SEP-18
Kleinostheim DE 63801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline Patient Cables and Lead Wires
Medline Industries, Inc. 510(k) NO: K181726(Traditional)
ATTN: Dinah Rincones PHONE NO : 847 9792687
Three Lakes Drive SE DECISION MADE: 20-SEP-18
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Beurer IPL 8500 device/ IPL VelvetSkin Pro
Home Well Trading LTD 510(k) NO: K181734(Traditional)
ATTN: Martin Gurovich PHONE NO : 213 3353521
Omar Hodge Building, Road Town SE DECISION MADE: 19-SEP-18
Tortola VG 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
Stryker GmbH 510(k) NO: K181742(Traditional)
ATTN: Tina Mornak PHONE NO : 201 8316365
325 Corporate Drive SE DECISION MADE: 27-SEP-18
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRORAPTOR Knotless Suture Anchor
Smith and Nephew, Inc. 510(k) NO: K181746(Traditional)
ATTN: Katherine Marcaccio PHONE NO : 508 2613602
7135 Goodlett Farms Parkway SE DECISION MADE: 28-SEP-18
Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Magnesium
Abbott Laboratories 510(k) NO: K181748(Traditional)
ATTN: Mark Littlefield PHONE NO : 972 5186062
1921 Hurd Drive SE DECISION MADE: 12-SEP-18
Irving TX 75038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex FiberTak Suture Anchor
Arthrex, Inc. 510(k) NO: K181769(Traditional)
ATTN: David L. Rogers PHONE NO : 239 6435553 71924
1370 Creekside Boulevard SE DECISION MADE: 21-SEP-18
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RightEye Vision System
RightEye, LLC 510(k) NO: K181771(Traditional)
ATTN: Adam Gross PHONE NO : 301 9797970
7979 Old Georgetown Rd., Suite 801SE DECISION MADE: 28-SEP-18
Bethesda MD 20814 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Synapse 3D Optional Tools
FUJIFILM Corporation 510(k) NO: K181773(Traditional)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 25-SEP-18
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOGIQ P9; LOGIQ P7
GE Healthcare 510(k) NO: K181783(Traditional)
ATTN: Bryan Behn PHONE NO : 262 2475502
9900 Innovation Drive SE DECISION MADE: 20-SEP-18
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VeriSuite
MedCom GmbH 510(k) NO: K181789(Abbreviated)
ATTN: Johannes Messow PHONE NO : 49 6151 9514720
Dolivostrasse 11 SE DECISION MADE: 21-SEP-18
Darmstadt DE 64293 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Truliant Porous Femoral Components
Exactech, Inc. 510(k) NO: K181794(Special)
ATTN: Patrick Hughes PHONE NO : 352 3274762
2320 NW 66th CT SE DECISION MADE: 28-SEP-18
Gainesville FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AST Model MA012 and MS019 Rehab Wheelchair
Sichuan AST Medical Equipment Co.,510(k) NO: K181795(Traditional)
ATTN: Johnson Van PHONE NO : 86 830 8130286
No.58, Jin-Peng Road, C Area, LuxiSE DECISION MADE: 25-SEP-18
Luzhou City CN 646100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ReTrace Ureteral Access Sheath
Coloplast A/S 510(k) NO: K181811(Special)
ATTN: Cori Ragan PHONE NO : 612 5975106
1601 West River Road North SE DECISION MADE: 07-SEP-18
Minneapolis MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water
Amsino International, Inc. 510(k) NO: K181814(Traditional)
ATTN: Cathy Hong PHONE NO : 909 6265888
708 Corporate Center Drive SE DECISION MADE: 04-SEP-18
Pomona CA 91768 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOSS VRS Spinal System
Biedermann Motech GmbH & Co. KG 510(k) NO: K181821(Traditional)
ATTN: Gerd Federle PHONE NO : 49 7720 8510545
Bertha-von-Suttner-Strasse 23 SE DECISION MADE: 13-SEP-18
Villingen-Schwenningen DE 78054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MX40 Mobile Digital X-ray System
Huestis Machine Corporation 510(k) NO: K181874(Traditional)
ATTN: Frederick M. Correira PHONE NO : 401 2535500 144
68 Buttonwood Street SE DECISION MADE: 14-SEP-18
Bristol RI 02809 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kiierr 272 Laser, Kiierr 148 Laser
Kiierr International, LLC 510(k) NO: K181878(Traditional)
ATTN: Michael Anderson PHONE NO : 435 8408199
863 East Downington Avenue SE DECISION MADE: 05-SEP-18
Salt Lake City UT 84105-3211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MTS Penicillin 0.002- 32 µg/mL
Liofilchem s. r. l. 510(k) NO: K181889(Traditional)
ATTN: Fabio Brocco PHONE NO : 39 085 8930745
Via Scozia zona ind.le SE DECISION MADE: 13-SEP-18
Roseto degli Abruzzi IT 64026 510(k) STATEMENT
DEVICE: 5 FR Dual Lumen Piper PICC
Piper Access LLC 510(k) NO: K181904(Traditional)
ATTN: Jay Muse PHONE NO : 801 2102886
3981 South 700 East Suite 15 SE DECISION MADE: 25-SEP-18
Salt Lake City UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InVivo Web Viewer
Anatomage Inc. 510(k) NO: K181926(Traditional)
ATTN: Changxin Xu PHONE NO : 408 8851474
303 N. Almaden Blvd. Suite 700 SE DECISION MADE: 21-SEP-18
San Jose CA 95110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30
Oxoid Limited (Part of Thermo Fish510(k) NO: K181975(Traditional)
ATTN: Philip Brame PHONE NO : 440 1256 694279
Wade Road SE DECISION MADE: 27-SEP-18
Basingstoke GB RG24 8PW 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OsseoScrew System
Alphatec Spine, Inc. 510(k) NO: K181980(Traditional)
ATTN: Jeremy Markovich PHONE NO : 760 4946893
5818 El Camino Real SE DECISION MADE: 25-SEP-18
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NxStage Connected Health System
NxStage Medical, Inc 510(k) NO: K181991(Traditional)
ATTN: Christina Marabella PHONE NO : 978 4505275
350 Merrimack Street SE DECISION MADE: 26-SEP-18
Lawrence MA 01843 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Chiral Surgical Pedicle Screw System
Chiral Surgical 510(k) NO: K181995(Traditional)
ATTN: Andy Choi PHONE NO : 973 2240437
17310 Red Hill Ave, STE 335 SE DECISION MADE: 20-SEP-18
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay
Arthrex Inc. 510(k) NO: K182039(Traditional)
ATTN: Courtney Smith PHONE NO : 1 239 6435553 71720
1370 Creekside Boulevard SE DECISION MADE: 28-SEP-18
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)
Hebei Titans Hongsen Medical Techn510(k) NO: K182043(Traditional)
ATTN: ShaoZhang Nan PHONE NO : 86 319 7295820
Eastern Industrial Zone SE DECISION MADE: 21-SEP-18
Nangong CN 051800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultravision™ Visual Field Clearing System
Alesi Surgical Ltd. 510(k) NO: K182053(Special)
ATTN: David Broderick PHONE NO : 44 02920 291022
Cardiff MediCentre, HeathPark SE DECISION MADE: 07-SEP-18
Cardiff GB CF14 4UJ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SECULOK™ ACP System
U&i Corporation 510(k) NO: K182055(Traditional)
ATTN: Kwang-Eun Song PHONE NO : 82 31 8606837
20, Sandan-ro 76beon-gil(Rd) SE DECISION MADE: 10-SEP-18
Uijeongbu-si KR 11781 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask
MEDTEC Inc. dba CIVCO Medical Solu510(k) NO: K182079(Third Party - Traditional)
ATTN: Alena Newgren PHONE NO : 319 2486650
1401 8th Street SE SE DECISION MADE: 07-SEP-18
Orange City IA 51041-3020 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Scope Antifogging System
Xodus Medical, Inc. 510(k) NO: K182080(Traditional)
ATTN: Paul Lloyd PHONE NO : 724 3375500
702 Prominence Drive SE DECISION MADE: 19-SEP-18
New Kensington PA 15068 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD
Eleckta Limited 510(k) NO: K182138(Traditional)
ATTN: Andrew Hedges PHONE NO : 44 1293 654201
Linac House, Fleming Way SE DECISION MADE: 05-SEP-18
Crawley GB rh10 9rr 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bi-Flex Evo
Promepla Sam 510(k) NO: K182144(Special)
ATTN: Alexandre Bareille PHONE NO : 377 97 984244
9 Avenue Albert II SE DECISION MADE: 07-SEP-18
Monaco MC 98000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CTXX85
Analogic Corporation 510(k) NO: K182147(Traditional)
ATTN: Karen Provencher PHONE NO : 978 3264668
8 Centennial Drive SE DECISION MADE: 07-SEP-18
Peabody MA 01960 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILVERBACK Gorilla Plating System
Paragon 28, Inc. 510(k) NO: K182148(Special)
ATTN: Eric Lintula PHONE NO : 888 7281888
4B Inverness Ct. E, STE 280 SE DECISION MADE: 07-SEP-18
Engelwood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultrasound System SONIMAGE HS1
KONICA MINOLTA, INC. 510(k) NO: K182153(Special)
ATTN: Tsutomu Fukui PHONE NO : 81 42 5898429
1 Sakura-machi SE DECISION MADE: 06-SEP-18
Hino-shi JP 191-8511 510(k) STATEMENT
DEVICE: BioSign Flu A+B
Princeton BioMeditech Corp. 510(k) NO: K182157(Special)
ATTN: Kyung-ah Kim PHONE NO : 732 2741000
4242 US Highway 1 SE DECISION MADE: 18-SEP-18
Monmouth Junction NJ 08852 510(k) STATEMENT
DEVICE: Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth
Imediplus, Inc. 510(k) NO: K182196(Third Party - Traditional)
ATTN: Moriah Hsieh PHONE NO : 886 3 6587700 325
2F, 12, ShengYi Rd. Sec.2 SE DECISION MADE: 11-SEP-18
Chupei City TW 30261 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: RiX70 DC
Trident s.r.l 510(k) NO: K182206(Traditional)
ATTN: Giorgio Rizzo PHONE NO : 39 03 02732485
Via Artigiani 4 SE DECISION MADE: 13-SEP-18
Castenedolo IT 25014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo.via View&GO (Version VA10A)
Siemens Healthcare GmbH 510(k) NO: K182208(Third Party - Abbreviated)
ATTN: Elango Alampalayam RangappanPHONE NO : 49 9191 184429
Siemensstr. 1 SE DECISION MADE: 07-SEP-18
Forchheim DE 91301 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: QT Ultrasound Breast Scanner - 1
QT Ultrasound LLC 510(k) NO: K182213(Special)
ATTN: Mark W. Lenox PHONE NO : 865 3822649
3 Hamilton Landing, Suite 160 SE DECISION MADE: 14-SEP-18
Novato CA 94949 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DizzyDoctor System 1.0.0
DizzyDoctor Systems, LLC 510(k) NO: K182214(Third Party - Traditional)
ATTN: Ian Purcell PHONE NO : 619 7645751
7625 Mesa College Drive, Suite 200SE DECISION MADE: 14-SEP-18
San Diego CA 92111 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A
Canon Medical Systems USA 510(k) NO: K182223(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 14-SEP-18
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AirStrip RPM InvisionHeart Adapter
AirStrip Technologies, Inc. 510(k) NO: K182226(Third Party - Traditional)
ATTN: Kirk Johnson PHONE NO : 210 8050444
335 E. Sonterra Blvd., Suite #200 SE DECISION MADE: 11-SEP-18
San Antonio TX 78258 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Multi Modality Viewer
Vital Images, Inc. 510(k) NO: K182230(Traditional)
ATTN: Fei Li PHONE NO : 952 4879539
5850 Opus Parkway, Suite 300 SE DECISION MADE: 07-SEP-18
Minnetonka MN 55343-4414 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Octane Mechanical Thrombectomy System
Vascular Solutions, Inc. 510(k) NO: K182232(Special)
ATTN: Iroquois Ledbeter PHONE NO : 763 6564300
6401 Sycamore Ct N SE DECISION MADE: 11-SEP-18
Maple Grove MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Optima XR240amx
GE Medical Systems, LLC 510(k) NO: K182234(Special)
ATTN: Chris Paulik PHONE NO : 262 5482010
3000 N. Grandview Blvd. SE DECISION MADE: 06-SEP-18
Waukesha WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The CVC WAND Safety Introducer with Valved Peelable Sheath
Access Scientific, LLC 510(k) NO: K182243(Special)
ATTN: Martina Nguyen PHONE NO : 858 2598333
3910 Sorrento Valley Boulevard, SuSE DECISION MADE: 18-SEP-18
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm
United States Endoscopy Group, Inc510(k) NO: K182258(Special)
ATTN: Carroll L. Martin PHONE NO : 440 3586259
5976 Heisley Road SE DECISION MADE: 21-SEP-18
Mentor OH 44060 510(k) STATEMENT
DEVICE: PALACOS MV
Heraeus Medical GmbH 510(k) NO: K182260(Special)
ATTN: Ute Greiner PHONE NO : 49 61 81352808
Philipp-Reis-Str. 8-13 SE DECISION MADE: 17-SEP-18
Wehrheim DE 61273 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RetCam 3 ; RetCam Shuttle ; RetCam Portable
Natus Medical Incorporated 510(k) NO: K182263(Special)
ATTN: Brian R. Ackley PHONE NO : 925 2011600
1183 Quarry Lane, Suite A SE DECISION MADE: 07-SEP-18
Pleasanton CA 94566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Seal Single Use Biopsy Valve
Boston Scientific Corporation 510(k) NO: K182275(Special)
ATTN: Andrew Akers PHONE NO : 508 6834612
100 Boston Scientific Way SE DECISION MADE: 13-SEP-18
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oh'Care Lite Smart Blood Glucose Monitoring System
OSANG Healthcare Co., Ltd. 510(k) NO: K182286(Special)
ATTN: Jin Ho An PHONE NO : 82 31 4600415
132, Anyangcheondong-Ro, Dongan-GuSE DECISION MADE: 19-SEP-18
Anyang KR 14040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IBM iConnect Access
Merge Healthcare Incorporated 510(k) NO: K182290(Traditional)
ATTN: Tracey Fox PHONE NO : 262 3670700
900 Walnut Ridge Drive SE DECISION MADE: 25-SEP-18
Hartland WI 53209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Volpara Imaging Software
Volpara Health Technologies Limite510(k) NO: K182310(Special)
ATTN: Ralph Highnam PHONE NO : 64 4 4996029
Level 7, 44 Victoria Street, WelliSE DECISION MADE: 21-SEP-18
Wellington NZ 6011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Magic Torque DLVR Guidewire
Boston Scientific Corporation 510(k) NO: K182315(Special)
ATTN: Andrea Dance PHONE NO : 763 4941743
3 Scimed Place SE DECISION MADE: 26-SEP-18
Maple Grove MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMADEO M-DR mini, AMADEO M-AX mini
OEHM UND REHBEIN GMBH 510(k) NO: K182317(Traditional)
ATTN: Markus Brueggmann PHONE NO : 49 381 36600730
Neptunallee 7 C SE DECISION MADE: 24-SEP-18
Rostock DE 18057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InMode RF System
Inmode MD Ltd. 510(k) NO: K182325(Special)
ATTN: Amit Goren PHONE NO : 972 4 9097470
Tabor Building, Shaar Yokneam SE DECISION MADE: 26-SEP-18
Yoqneam Illit IL 2069200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CPX 4 Breast Tissue Expander with Smooth Surface
Mentor Worldwide LLC 510(k) NO: K182335(Special)
ATTN: Martin Sprunck PHONE NO : 949 7898589
33 Technology Drive SE DECISION MADE: 25-SEP-18
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NICO Myriad
NICO Corporation 510(k) NO: K182340(Special)
ATTN: Sean Spence PHONE NO : 317 6607118
250 East 96th Street, Suite 125 SE DECISION MADE: 20-SEP-18
Indianapolis IN 46240 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spineology Navigation Instruments
Spineology Inc 510(k) NO: K182345(Special)
ATTN: Karen Roche PHONE NO : 651 2568500
7800 Third Street N., Suite 600 SE DECISION MADE: 21-SEP-18
St. Paul MN 55128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HardyDisk AST Eravacycline 20µg (ERV20)
Hardy Diagnostics 510(k) NO: K182357(Traditional)
ATTN: Anna Klavins PHONE NO : 800 2662222 5752
1430 West McCoy Lane SE DECISION MADE: 26-SEP-18
Santa Maria CA 93455 510(k) STATEMENT
DEVICE: Acculoc Total Knee System
RootLoc Co., Ltd. 510(k) NO: K182370(Special)
ATTN: Jungsun Ha PHONE NO : 82 2 69414300
#1206, 1210, 68, Digital-ro 9-gil,SE DECISION MADE: 27-SEP-18
Seoul KR 08512 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Harmony
Topcon Medical Systems, Inc. 510(k) NO: K182376(Special)
ATTN: James Lorkowski PHONE NO : 201 5995553
111 Bauer Drive SE DECISION MADE: 28-SEP-18
Oakland NJ 07436 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CarboClear® Pedicle Screw System
CarboFix Orthopedics Ltd. 510(k) NO: K182377(Special)
ATTN: Hila Wachsler-Avrahami PHONE NO : 972 99511511
11 Ha'hoshlim St. SE DECISION MADE: 27-SEP-18
Herzeliya IL 4672411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoLink View Plating System
In2Bones USA, LLC 510(k) NO: K182402(Special)
ATTN: Christine Scifert PHONE NO : 901 8318053
6060 Poplar Ave, Suite 380 SE DECISION MADE: 27-SEP-18
Memphis TN 38119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alphenix, INFX-8000F/B, V8.0
Canon Medical Systems Corporation 510(k) NO: K182415(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 28-SEP-18
Otawara JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 203
TOTAL WITH SUMMARIES 193
TOTAL WITH STATEMENTS 10
