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  1. 510(k) Clearances

September 2019 510(K) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD September 2019


DEVICE: Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant
Embla Systems                     510(k) NO: K180001(Abbreviated)
ATTN: Sanjay  Mehta               PHONE NO : 905 2875055 
1 Hines Road Suite 202            SE DECISION MADE: 27-SEP-19
Kanata  CA K2K 3C7                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INTAI Surgery Navigation System
Intai Technology Corporation      510(k) NO: K180523(Traditional)
ATTN: Shih-Chang  Chuang          PHONE NO : 886 4 23595336 23489
No. 9 Jingke Rd., Nantun Dist.,   SE DECISION MADE: 20-SEP-19
Taichung City  TW 40852           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sapphire Dorsal Comfort Fit
Crane Dental Laboratory, Inc      510(k) NO: K181416(Traditional)
ATTN: Sharlene  Schultz           PHONE NO : 585 7305100 
3515 Buffalo Road Suite 30        SE DECISION MADE: 17-SEP-19
Rochester NY  14624               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clyra Wound Irrigation Solution
Clyra Medical Technologies Inc.   510(k) NO: K181428(Traditional)
ATTN: Steven V. Harrison          PHONE NO : 949 6439540 
14921 Chestnut St.                SE DECISION MADE: 20-SEP-19
Westminster CA  92683             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Roosin Xeroform Petrolatum Dressing
Roosin Medical Co., Ltd           510(k) NO: K181478(Traditional)
ATTN: Charles  Shen               PHONE NO : 086 523 86908085 
8 Yuandong Road, KouAn Town, GaogaSE DECISION MADE: 13-SEP-19
Taizhou  CN 225321                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Precise SHP Diode Laser
CAO Group, Inc.                   510(k) NO: K181601(Traditional)
ATTN: Robert K. Larsen            PHONE NO : 801 2569282 
4628 West Skyhawk Drive           SE DECISION MADE: 09-SEP-19
West Jordan UT  84084             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pioneer Elite Diode Laser
CAO Group, Inc.                   510(k) NO: K181602(Traditional)
ATTN: Robert K. Larsen            PHONE NO : 801 2569282 
4628 West Skyhawk Drive           SE DECISION MADE: 10-SEP-19
West Jordan UT  84084             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Precision Spine Navigation Instrumentation
Precision Spine, Inc.             510(k) NO: K181606(Traditional)
ATTN: Michael C. Dawson           PHONE NO : 601 4204244 
2050 Executive Drive              SE DECISION MADE: 27-SEP-19
Pearl MS  39208                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterling Supreme Diode Laser
CAO Group, Inc.                   510(k) NO: K181614(Traditional)
ATTN: Robert K. Larsen            PHONE NO : 801 2569282 
4628 West Skyhawk Drive           SE DECISION MADE: 10-SEP-19
West Jordan UT  84084             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Klinly Ultrasonic Tongue Cleaner
KEA Products Ltd                  510(k) NO: K181986(Traditional)
ATTN: Michael  Schmidt            PHONE NO : 852 2798 6882 
10C, Meyer Ind. Bldg, 2 Chong Yip SE DECISION MADE: 06-SEP-19
Kwun Tong  HK 00000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dia-Proseal
Diadent Group International       510(k) NO: K182009(Traditional)
ATTN: Myung  Sub Kim              PHONE NO : 82 43 2662315 
16, Osongsaengmyeong 4-ro, Osong-eSE DECISION MADE: 26-SEP-19
Cheongji-si  KR 28161             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UPnRIDE
UPnRIDE Robotics Ltd.             510(k) NO: K182257(Traditional)
ATTN: Yoram  Levy                 PHONE NO : 972 4 6110061 
Kochav Yokneam Bld.               SE DECISION MADE: 12-SEP-19
Yokneam  IL 2069204               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VORTRAN APM-Plus
VORTRAN Medical Technology 1, Inc.510(k) NO: K182292(Traditional)
ATTN: James  Lee                  PHONE NO : 916 6488460 
21 Goldenland Court, Suite 100    SE DECISION MADE: 18-SEP-19
Sacramento CA  95834              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Secret RF Smartcure Applicator with electrodes
Ilooda Co., Ltd.                  510(k) NO: K182355(Traditional)
ATTN: Yun-Jung  Ha                PHONE NO : 82 031 2101622 
120, Jangan-ro 458 Beon-gil, JangaSE DECISION MADE: 06-SEP-19
Suwon-Si  KR                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: "SupaScoota" Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)
Eurogreen International Inc.      510(k) NO: K182631(Traditional)
ATTN: David  Hsieh                PHONE NO : 886 4 8319633 
No. 48, Lane 220, Sec. 1, Fu-Zun RSE DECISION MADE: 19-SEP-19
Chang-Hua County  CN 51055        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medi-Direct TENS Pen
JKH USA, LLC                      510(k) NO: K182671(Traditional)
ATTN: Bill Quanqin Dai            PHONE NO : 909 9299896 
1142 S. Diamond Bar Blvd, #861    SE DECISION MADE: 21-SEP-19
Diamond Bar CA  91765             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XLR8 Abdominal Wound Dressing Kit
Genadyne Biotechnologies          510(k) NO: K182722(Traditional)
ATTN: Swara  Vashi                PHONE NO : 516 4878787 
16 Midland Ave                    SE DECISION MADE: 27-SEP-19
Hicksville NY  11801              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reusable Temperature Probe
Shenzhen Caremed Medical Technolog510(k) NO: K182751(Traditional)
ATTN: Alan  Xie                   PHONE NO : 86 755 36560977 889
East Side, 3/F, C Building, KeluntSE DECISION MADE: 06-SEP-19
Dalang Office, Longhua District, S510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe
TOP Corporation                   510(k) NO: K182765(Traditional)
ATTN: Sho  Yokoya                 PHONE NO : 
19-10 Senju Nakai-cho             SE DECISION MADE: 03-SEP-19
Adachi-ku  JP 120-0035            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cytomics FC 500 Series (MPL or MCL) Flow Cytometer
Beckman Coulter                   510(k) NO: K182886(Traditional)
ATTN: Samy  Puccio                PHONE NO : 305 3804509 
11800 SW 147th Ave                SE DECISION MADE: 06-SEP-19
Miami FL  33196-2500              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infinix Universal Composite
Nobio Ltd.                        510(k) NO: K182921(Traditional)
ATTN: Inbal Beinglass Peled       PHONE NO : 972 3 9059966 
8 Hamatechet St.                  SE DECISION MADE: 13-SEP-19
Kadima  IL 6092000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Steerable catheter control system
Stereotaxis, Inc.                 510(k) NO: K183027(Traditional)
ATTN: Kenneth H. Lock             PHONE NO : 314 6786123 
4320 Forest Park Avenue, Suite 100SE DECISION MADE: 06-SEP-19
St. Louis MO  63108               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EMS Belt (Model MC0485)
Dongguan Yingfeng Metal & Plastic 510(k) NO: K183103(Traditional)
ATTN: Zesheng  Chen               PHONE NO : 86 769 83349883 
Bianpu District, Lianhu Road, QiaoSE DECISION MADE: 18-SEP-19
Dongguan  CN 523520               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuStat
Beeken Biomedical, LLC            510(k) NO: K183190(Traditional)
ATTN: Richard A. Kendall          PHONE NO : 888 4977376 
378 Page St, Suite 201            SE DECISION MADE: 25-SEP-19
Stoughton MA  02072               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Focus TENS Therapy, Model PM710-M/-L
Omron Healthcare, Inc.            510(k) NO: K183215(Traditional)
ATTN: Renee  Thornborough         PHONE NO : 847 2475626 
1925 West Field Court, Suite 100  SE DECISION MADE: 07-SEP-19
Lake Forest IL  60045             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AI-Rad Companion (Cardiovascular)
Siemens Medical Solutions USA, Inc510(k) NO: K183268(Traditional)
ATTN: Kimberly  Rendon            PHONE NO : 610 4486477 
40 Liberty Blvd.                  SE DECISION MADE: 10-SEP-19
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: K3
Osstem Implant Co., Ltd.          510(k) NO: K183347(Traditional)
ATTN: Hyeri  Han                  PHONE NO : 82 070 46260881 
1st Floor, B-dong, 135 Gasan DigitSE DECISION MADE: 04-SEP-19
Seoul  KR 08504                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bellavista
Imtmedical AG                     510(k) NO: K183364(Traditional)
ATTN: Beat  Keller                PHONE NO : 41 81 7506699 
Gewerbestrasse 8                  SE DECISION MADE: 13-SEP-19
Buchs SG  CH 9470                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PeraMobile and PeraWatch
PeraHealth, Inc.                  510(k) NO: K183370(Traditional)
ATTN: Brad  Coleman               PHONE NO : 401 4000401 
6302 Fairview Rd.,Suite 310       SE DECISION MADE: 11-SEP-19
Charlotte NC  28210               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Novidia Universal Bond
Nobio Ltd.                        510(k) NO: K183391(Traditional)
ATTN: Inbal Beinglass Peled       PHONE NO : 972 9 7893000 
8 Hamatechet St.                  SE DECISION MADE: 24-SEP-19
Kadima  IL 6092000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rhino-Laryngo Videoscope Olympus ENF-VT3
Olympus Medical Systems Corp.     510(k) NO: K183416(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 06-SEP-19
Hachioji-shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVIS EXERA III Bronchovideoscope Olympus BF-XT190
Olympus Medical Systems Corp.     510(k) NO: K183419(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 05-SEP-19
Hachioji-Shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FUJIFILM Ultrasonic Endoscope
Fujifilm Corporation              510(k) NO: K183433(Traditional)
ATTN: Randy  Vader                PHONE NO : 360 3566821 
798 Miyanodai Kaisei-Machi        SE DECISION MADE: 05-SEP-19
Ashigarakami-Gun  JP 258-8538     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OraCure
TBM Corporation                   510(k) NO: K183436(Traditional)
ATTN: Jae-woong  Jeong            PHONE NO : 82 2 9712845 
B-301, Gwangju High-tech Center, 3SE DECISION MADE: 18-SEP-19
Gwangju  KR 61008                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Geomed Vascular Dilators
Geomed Medizin-Technik GmbH & Co. 510(k) NO: K183438(Traditional)
ATTN: Hanno  Haug                 PHONE NO : 011 497461 93550 
Ludwigstaler Strasse 27           SE DECISION MADE: 03-SEP-19
Tuttlingen  DE 78532              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector
Cenorin, LLC                      510(k) NO: K183444(Traditional)
ATTN: Jenette A. Bennett          PHONE NO : 253 3952400 
6324 South 199th Place Suite 107  SE DECISION MADE: 09-SEP-19
Kent WA  98032                    510(k) STATEMENT
                                                    

DEVICE: PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
PENTAX of America, Inc.           510(k) NO: K183516(Traditional)
ATTN: William  Goeller            PHONE NO : 201 5712300 2318
3 Paragon Drive                   SE DECISION MADE: 06-SEP-19
Montvale NJ  07645-1782           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CNAP Monitor
CNSystems Medizintechnik GmbH     510(k) NO: K183521(Traditional)
ATTN: Bernd  Wellisch             PHONE NO : 0043 7 234560 
Reininghausstrasse 13             SE DECISION MADE: 11-SEP-19
Graz  AT 8020                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F
Olympus Medical Systems Corp.     510(k) NO: K183525(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 06-SEP-19
Hachioji-Shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Holinwon 30
Won Tech Co., Ltd.                510(k) NO: K183563(Traditional)
ATTN: Jake  Yu                    PHONE NO : 82 70 78366921 
64 Techno 8-Ro, Yuseong-gu        SE DECISION MADE: 05-SEP-19
Daejeon  KR 34028                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes
Huntleigh Healthcare Ltd          510(k) NO: K183574(Abbreviated)
ATTN: Steve  Monks                PHONE NO : 44 2920 485885 
35 Portmanmoor Road               SE DECISION MADE: 06-SEP-19
Cardiff  GB CF24 5HN              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CapMedic
Cognita Labs, LLC                 510(k) NO: K183586(Traditional)
ATTN: Rajoshi  Biswas             PHONE NO : 832 5383042 
700 N Main St. Ste C1             SE DECISION MADE: 13-SEP-19
Santa Ana CA  92701               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Saline Wound Wash, SteriCleanse(TM)
Ascent Consumer Products, Inc.    510(k) NO: K183662(Traditional)
ATTN: Matthew  Kornberg           PHONE NO : 631 7551155 
105 Baylis Road                   SE DECISION MADE: 12-SEP-19
Melville NY  11747                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use
Jiangsu Micsafe Medical Technology510(k) NO: K183665(Traditional)
ATTN: Tony  Yang                  PHONE NO : 086 1365 1929266 
Xituan Industrial Park, Dafeng DisSE DECISION MADE: 06-SEP-19
Yancheng  CN 224125               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens ; OxyPure A (olifilcon A) Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens
Visco Vision Inc                  510(k) NO: K183670(Traditional)
ATTN: Evan  Huang                 PHONE NO : 886 3 3596868 
No. 1, Xingye St., Guishan Dist., SE DECISION MADE: 13-SEP-19
Taoyuan City  TW 33341            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3D Visualization System
Scivita Medical Technology Co., Lt510(k) NO: K183675(Traditional)
ATTN: Ruqin  Wu                   PHONE NO : 86 512 81877788 
No.8, Zhong Tian Xiang, Suzhou IndSE DECISION MADE: 25-SEP-19
Suzhou  CN 215000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LifeWindow LW8 Lite
Digicare Biomedical Technology, In510(k) NO: K183687(Traditional)
ATTN: Eduardo  Miranda            PHONE NO : 1 561 6890408 
107 Commerce Rd.                  SE DECISION MADE: 25-SEP-19
Boynton Beach FL  33426           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OrthoAnalysis Software
Inteware Co., Ltd.                510(k) NO: K183695(Traditional)
ATTN: Wayne  Tsai                 PHONE NO : 886 965 111210 
4F., No.93, Xinzheng 5th St., TaiwSE DECISION MADE: 12-SEP-19
Minxiong Township, Chiayi Country 510(k) STATEMENT
                                                    

DEVICE: Poly Clear
Medtek Skincare, LLC              510(k) NO: K183708(Traditional)
ATTN: Gary  Richardson            PHONE NO : 518 7473310 
3 Depot Street                    SE DECISION MADE: 17-SEP-19
Hudson Falls NY  12839            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Supercath 5
TOGO MEDIKIT Co., Ltd.            510(k) NO: K190001(Traditional)
ATTN: Daisuke  Nagamizu           PHONE NO : 011 81 982538000 
17148-6 Aza Kamekawa, Oaza HichiyaSE DECISION MADE: 20-SEP-19
Hyuga City  JP 883-0062           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use
Shanghai Kohope Medical Devices Co510(k) NO: K190002(Traditional)
ATTN: Yibing  Wang                PHONE NO : 86 21 60836369 
Room 1001, No.2 building, Lane 288SE DECISION MADE: 12-SEP-19
Shanghai  CN 200331               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterilucent HC 80TT Hydrogen Peroxide Sterilizer
Sterilucent, Inc.                 510(k) NO: K190005(Traditional)
ATTN: Peter  Kalkbrenner          PHONE NO : 612 7673253 
1400 Marshall St. NE              SE DECISION MADE: 13-SEP-19
Minneapolis MN  55413             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SafeBreath Filter Mouthpiece
MD Diagnostics Limited            510(k) NO: K190022(Traditional)
ATTN: Glen  Hillsley              PHONE NO : 440 1622 682686 
15 Hollingworth Court, Turkey MillSE DECISION MADE: 25-SEP-19
Maidstone  GB ME14 5pp            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smart-C
Turner Imaging Systems, Inc.      510(k) NO: K190024(Abbreviated)
ATTN: Michael  Drake              PHONE NO : 801 7962951 
1119 South 1680 West              SE DECISION MADE: 27-SEP-19
Orem UT  84058                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar
Changzhou Xin Neng Yuan Medical St510(k) NO: K190029(Traditional)
ATTN: Boping  Ma                  PHONE NO : 86 519 88830515 
No. 51 Shuishan Road, Zhonglou EcoSE DECISION MADE: 26-SEP-19
Changzhou  CN 213023              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UF(II) Anatomic abutment
DIO Corporation                   510(k) NO: K190048(Traditional)
ATTN: Jiae  Park                  PHONE NO : 82 51 7457836 
66, Centum Seo-ro, Haeundae-gu    SE DECISION MADE: 30-SEP-19
Busan  KR 48058                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sim&Size
Sim&Cure                          510(k) NO: K190049(Traditional)
ATTN: Krishna  Mahadea            PHONE NO : 33 09 53405182 
1682 Rue de la Valsiere           SE DECISION MADE: 17-SEP-19
Grabels  FR 34790                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CEREC Guides
Dentsply Sirona                   510(k) NO: K190059(Traditional)
ATTN: Karl J. Nittinger           PHONE NO : 717 8494424 
221 West Philadelphia St., Suite 6SE DECISION MADE: 27-SEP-19
York PA  17401                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems
Cepheid                           510(k) NO: K190076(Traditional)
ATTN: Yi-Ping  Lin                PHONE NO : 408 4006838 
904 Caribbean Drive               SE DECISION MADE: 27-SEP-19
Sunnyvale CA  94089               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: USTAR II System
United Orthopedic Corporation     510(k) NO: K190100(Traditional)
ATTN: Lois  Ho                    PHONE NO : 886 3 5773351 2220
No 57, Park Ave 2, Science Park   SE DECISION MADE: 23-SEP-19
Hsinchu  TW 30075                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SepaSperm Washing Solution, SepaSperm Solution
Kitazato Corporation              510(k) NO: K190199(Traditional)
ATTN: Futoshi  Inoue              PHONE NO : 81 545 662202 
81 Nakajima                       SE DECISION MADE: 26-SEP-19
Fuji-shi  JP 416-0907             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Yikang Endotracheal Tube
Jiangxi Yikang Medical Instrument 510(k) NO: K190213(Traditional)
ATTN: Nicholas  Su                PHONE NO : 86 791 85632226 
188 Aihua Road, Jinxian County    SE DECISION MADE: 06-SEP-19
Nanchang  CN 331725               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Microscope Navigation
Brainlab AG                       510(k) NO: K190250(Special)
ATTN: Alexander  Schwiersch       PHONE NO : 49 89 9915680 
Olof-Palme-Str. 9                 SE DECISION MADE: 06-SEP-19
Munich  DE                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex Tenodesis Button
Arthrex Inc.                      510(k) NO: K190288(Traditional)
ATTN: Ivette  Galmez              PHONE NO : 1 239 6435553 71263
1370 Creekside Boulevard          SE DECISION MADE: 13-SEP-19
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1)
AMD Medicom, Inc.                 510(k) NO: K190308(Traditional)
ATTN: Ronald  Reuben              PHONE NO : 514 6366262 
2555 Chemin de l'Aviation, Pointe-SE DECISION MADE: 17-SEP-19
Montreal  CA H9P 2Z2              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aloe Glide Lubricant
Desert Harvest, Inc               510(k) NO: K190323(Traditional)
ATTN: Heather  Florio             PHONE NO : 919 2451853 
437 Dimmocks Mill Rd Suite 17b    SE DECISION MADE: 25-SEP-19
Hillsborough NC  27278            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GM501 Wash
Hamilton Thorne, Inc.             510(k) NO: K190383(Traditional)
ATTN: Donald  Fournier            PHONE NO : 1 978 2050 
100 Cummings Center, Suite 465E   SE DECISION MADE: 05-SEP-19
Beverly MA  01915                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Republic Spine Restore Intervertebral Body Fusion System
Republic Spine LLC                510(k) NO: K190398(Traditional)
ATTN: James  Doulgeris            PHONE NO : 561 3628094 
350 Camino Gardens Blvd Suite 103 SE DECISION MADE: 12-SEP-19
Boca Raton FL  33432              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs
Ever Global (Vietnam) Enterprise C510(k) NO: K190403(Third Party - Abbreviated)
ATTN: Jerry  Lin                  PHONE NO : 84 61 3514022 
No.1 Road, Long Thanh Industrial ZSE DECISION MADE: 06-SEP-19
Long Tanh District  VN 810000     510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue) - Extended Cuff
Hartalega Ngc Sdn. Bhd.           510(k) NO: K190454(Traditional)
ATTN: Kuan Kam Hon                PHONE NO : 603 62771733 
Dataran Sd Pju 9                  SE DECISION MADE: 26-SEP-19
Bandar Sri Damansara  MY 52200    510(k) STATEMENT
                                                    

DEVICE: PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate
Shen Wei USA Inc.                 510(k) NO: K190466(Traditional)
ATTN: Cheryl  Reep                PHONE NO : 510 4298692 
33278 Central Ave Ste 102         SE DECISION MADE: 26-SEP-19
Union City CA  94587              510(k) STATEMENT
                                                    

DEVICE: ACIST RXi System and Navvus II Catheter
ACIST Medical Systems, Inc.       510(k) NO: K190473(Traditional)
ATTN: Sherri  Mellingen           PHONE NO : 952 9959300 
7905 Fuller Road                  SE DECISION MADE: 13-SEP-19
Eden Prairie MN  55344            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPIRA Open Matrix ALIF and LLIF
Camber Spine Technologies         510(k) NO: K190483(Traditional)
ATTN: Erin  Kriebel               PHONE NO : 484 4277060 
501 Allendale Road                SE DECISION MADE: 23-SEP-19
King of Prussia PA  19406         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BH Medical Dental Barrier Sleeves and Barrier Film
BH Medical Products Co., Ltd.     510(k) NO: K190484(Traditional)
ATTN: Xiaohua  TAO                PHONE NO : 86 519 83978705 
No.90 Shenjiang Villagers' group, SE DECISION MADE: 10-SEP-19
Changzhou  CN 213024              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gem FlowCoupler System
Baxter/ Synovis Micro Companies Al510(k) NO: K190499(Traditional)
ATTN: Julie  Carlston             PHONE NO : 651 7967511 
2875 University Ave. West         SE DECISION MADE: 06-SEP-19
St. Paul MN  55114                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Full Automatic (NIBP) Blood Pressure Monitor
Health & Life Co. ltd.            510(k) NO: K190507(Traditional)
ATTN: J.S.  Hsu                   PHONE NO : 886 2 82271300 1201
9F, No. 186 Jian Yi Road          SE DECISION MADE: 16-SEP-19
Zhonghe District, New Taipei City 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws
CarboFix Orthopedics Ltd.         510(k) NO: K190526(Traditional)
ATTN: Hila  Wachsler-Avrahami     PHONE NO : 972 9 9511511 
11 Ha'hoshlim St.                 SE DECISION MADE: 19-SEP-19
Herzeliya  IL 4672411             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mediracer NCS
Mediracer Oy                      510(k) NO: K190536(Traditional)
ATTN: Lassi  Laitinen             PHONE NO : 358 400 148881 
Rantakatu 4                       SE DECISION MADE: 25-SEP-19
Oulu  FI 90100                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage
Solco Biomedical Co., Ltd.        510(k) NO: K190563(Traditional)
ATTN: Il  Kim                     PHONE NO : 82 31 6644101 
154 Seotan-ro, Seotan-myeon       SE DECISION MADE: 18-SEP-19
Pyeongtaek  KR 17704              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Patient Assistant Model PA97000
Medtronic, Inc                    510(k) NO: K190574(Traditional)
ATTN: Cheryl  Swanson             PHONE NO : 763 5140088 
8200 Coral Sea Street NE          SE DECISION MADE: 24-SEP-19
Mounds View MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Encompass 15 Channel Head Coil, 3T
Qfix                              510(k) NO: K190668(Traditional)
ATTN: Alexandra Low Smythe        PHONE NO : 610 2680585 736
440 Church Road                   SE DECISION MADE: 09-SEP-19
Avondale PA  19311                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: External Counterpulsation System
Vamed Medical Instrument Co., Ltd 510(k) NO: K190683(Traditional)
ATTN: Ji  Mia                     PHONE NO : 86 757 83817601 
1 of 8 Floor, 2# Building, No. 60,SE DECISION MADE: 10-SEP-19
Foshan  CN 528000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AccelFix Lumbar Interbody Fusion Cage System
L&K Biomed Co., Ltd.              510(k) NO: K190708(Traditional)
ATTN: Jihyeon  Seo                PHONE NO : 82 2 67171983 
#201, 202 16-25, Dongbaekjungang-rSE DECISION MADE: 16-SEP-19
Yongin-si  KR 17015               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Opus Bulk Fill APS, Opus Bulk Fill Flow APS
DentsCare LTDA                    510(k) NO: K190758(Traditional)
ATTN: Roberta  Uyara              PHONE NO : 55 47 34416131 
Av. Edgar Nelson Meister, 474     SE DECISION MADE: 04-SEP-19
Joinville  BR 89219-501           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARTIS icono
Siemens Medical Solutions USA, Inc510(k) NO: K190768(Traditional)
ATTN: Patricia D. Jones           PHONE NO : 610 4486474 
40 Liberty Boulevard 65-1A        SE DECISION MADE: 12-SEP-19
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo Application Software
Siemens Medical Solution USA, Inc.510(k) NO: K190780(Traditional)
ATTN: Patricia D. Jones           PHONE NO : 610 4486474 
40 Liberty Boulevard 65-1A        SE DECISION MADE: 12-SEP-19
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BrainScope TBI
BrainScope Company, Inc.          510(k) NO: K190815(Traditional)
ATTN: Michael  Singer             PHONE NO : 240 7527680 
4330 East West Highway, Suite #100SE DECISION MADE: 11-SEP-19
Bethesda MD  20814                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TDM Screw Systems
TDM Co. Ltd.                      510(k) NO: K190830(Traditional)
ATTN: Youngdae  Kim               PHONE NO : 82 62 6027460 
69, Cheomdan Venture so-ro, 37 beoSE DECISION MADE: 13-SEP-19
Gwangju  KR 61003                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SCENARIA View
Hitachi Healthcare Americas       510(k) NO: K190841(Traditional)
ATTN: Aaron  Pierce               PHONE NO : 
1959 Summit Commerce Park         SE DECISION MADE: 13-SEP-19
Twinsburg OH  44087               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Akesis Galaxy
Akesis Inc                        510(k) NO: K190844(Traditional)
ATTN: Christopher  Brown          PHONE NO : 925 4081381 
5129 Commercial Circle            SE DECISION MADE: 04-SEP-19
Concord CA  94520                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SeeFactorCT3
Epica International Inc.          510(k) NO: K190856(Traditional)
ATTN: Daniel  Naimey              PHONE NO : 425 9417365 
2753 Camino Capistrano. Suite A-10SE DECISION MADE: 20-SEP-19
San Clemente CA  92672            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant
United Consortium                 510(k) NO: K190858(Traditional)
ATTN: Stephanie  Morris           PHONE NO : 661 2951700 
29000 N. Hancock Pkwy.            SE DECISION MADE: 18-SEP-19
Valencia CA  91355                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pulse Oximeter
Shenzhen Aeon Technology Co., Ltd.510(k) NO: K190869(Traditional)
ATTN: Xie  Hua                    PHONE NO : 86 1390 2955475 
RM6H02, Block 27-29, Tianxia IC InSE DECISION MADE: 13-SEP-19
Shenzhen  CN 518052               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)
D.O.R.C. Dutch Ophthalmic Research510(k) NO: K190875(Traditional)
ATTN: Linda Van Leeuwen           PHONE NO : 31 181 458080 
B.V. Scheijdelveweg 2             SE DECISION MADE: 25-SEP-19
Zuidland  NL 3214 VN              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: bili-hut
Little Sparrows Technologies, Inc.510(k) NO: K190899(Traditional)
ATTN: Erica  Konston              PHONE NO : 410 7031406 
176 Mystic Valley Parkway         SE DECISION MADE: 05-SEP-19
Winchester MA  01890              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SmarTemp X1
Parkell, Inc.                     510(k) NO: K190930(Traditional)
ATTN: David  Mott                 PHONE NO : 631 3891134 
300 Executive Drive               SE DECISION MADE: 05-SEP-19
Edgewood NY  11717                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RFID Localization System
Health Beacons, Inc.              510(k) NO: K190932(Traditional)
ATTN: Nancy  Confrey              PHONE NO : 978 2874635 
34 Walden St. #753                SE DECISION MADE: 13-SEP-19
Concord MA  01742                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Advocate Non-Contact Infrared Thermometer
BroadMaster Biotech, Corp.        510(k) NO: K191004(Traditional)
ATTN: Jen  Ke-Min                 PHONE NO : 886 3 4517600 
1F., 2F., No. 91, Xiyuan Rd., ZhonSE DECISION MADE: 05-SEP-19
Taoyuan  TW 32057                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EasiSlush
Bridge to Life Ltd.               510(k) NO: K191006(Traditional)
ATTN: Tom  Keller                 PHONE NO : 803 5450080 
128 Suber Rd. Suite A             SE DECISION MADE: 24-SEP-19
Columbia SC  29210                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option
Welch Allyn, Inc.                 510(k) NO: K191013(Traditional)
ATTN: Megan  Pellenz              PHONE NO : 414 3541600 
7865 North 86th St.               SE DECISION MADE: 10-SEP-19
Milwaukee WI  53224               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye
Terragene SA                      510(k) NO: K191021(Traditional)
ATTN: Maria Victoria Rocha        PHONE NO : 54 341 5587007 
Ruta Nacional No. 9, Km 280, ParquSE DECISION MADE: 13-SEP-19
Alvear  AR 2130                   510(k) STATEMENT
                                                    

DEVICE: VPS Impression Material
Hygedent Inc.                     510(k) NO: K191034(Traditional)
ATTN: Peng  Wang                  PHONE NO : 010 139 01284956 
Room 210C, Building 4, No 5 ChaoqiSE DECISION MADE: 04-SEP-19
Beijing  CN 102299                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Signia Small Diameter Reloads
Covidien                          510(k) NO: K191070(Traditional)
ATTN: Frank  Gianelli             PHONE NO : 203 4925352 
60 Middletown Avenue              SE DECISION MADE: 04-SEP-19
North Haven CT  06473             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sorrento Bone Graft Substitute
Xenco Medical, LLC                510(k) NO: K191074(Traditional)
ATTN: Jason  Haider               PHONE NO : 858 2021505 
9930 Mesa Rim Road                SE DECISION MADE: 27-SEP-19
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Precision S 4K Sinuscope
Stryker                           510(k) NO: K191102(Traditional)
ATTN: Jessie  Duong               PHONE NO : 408 7542077 
5900 Optical Court                SE DECISION MADE: 06-SEP-19
San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GEHC DXA Bone Densitometers with enCORE version 18
GE Medical Systems Ultrasound & Pr510(k) NO: K191112(Traditional)
ATTN: Martha  Kamrow              PHONE NO : 262 5482573 
3030 Ohmeda Drive                 SE DECISION MADE: 19-SEP-19
Madison WI  53718                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: geko T-2 and geko T-3 Neuromuscular Stimulators
Firstkind Limited                 510(k) NO: K191113(Traditional)
ATTN: Neil  Buckley               PHONE NO : 44 01494 572040 
Hawk House, Peregrine Business ParSE DECISION MADE: 18-SEP-19
High Wycombe  GB HP13 7DL         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Apioc (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc P for Presbyopia (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc A for Astigmatism (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc AP (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens
Lentechs, LLC                     510(k) NO: K191121(Traditional)
ATTN: Robin  Sears                PHONE NO : 614 4873700 
1275 Kinnear Road                 SE DECISION MADE: 06-SEP-19
Columbus OH  43212                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set
Medtronic Sofamor Danek, USA Inc. 510(k) NO: K191148(Traditional)
ATTN: Shweta  Sharma              PHONE NO : 901 3992425 
1800 Pyramid Place                SE DECISION MADE: 12-SEP-19
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Myo Plus
Otto Bock Healthcare Products GmbH510(k) NO: K191179(Traditional)
ATTN: Rene  Urtz                  PHONE NO : 43 1 5233786707 
Brehmstrabe 16 1110 Wien          SE DECISION MADE: 04-SEP-19
Vienna  AT                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dornier MINNOW Ureteral Catheter
Dornier MedTech America Inc       510(k) NO: K191187(Traditional)
ATTN: John  Hoffer                PHONE NO : 770 5146163 
1155 Roberts Blvd, Suite 100      SE DECISION MADE: 18-SEP-19
Kennesaw GA  30144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System
Medos International SARL          510(k) NO: K191212(Traditional)
ATTN: Sergio M. Cordeiro          PHONE NO : 508 9772640 
Chemin-Blanc 38                   SE DECISION MADE: 24-SEP-19
Le Locle  CH 2400                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AccuCath Ace Intravascular Catheter
C.R. Bard, Inc                    510(k) NO: K191232(Traditional)
ATTN: Mona  Shahrebani            PHONE NO : 801 5225967 
605 North 5600 West               SE DECISION MADE: 18-SEP-19
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HEDRON Cervical Spacers
Globus Medical Inc.               510(k) NO: K191243(Traditional)
ATTN: Kelly  Baker                PHONE NO : 610 9301800 1670
2560 General Armistead Ave.       SE DECISION MADE: 17-SEP-19
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reusable NIBP Cuff
Shenzhen Changke Connect Electroni510(k) NO: K191253(Traditional)
ATTN: Yahui  Zhou                 PHONE NO : 86 13 613012560 
A2-4th floor of Xiang dali TechnolSE DECISION MADE: 17-SEP-19
Longgang District, Shenzhen  CN   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Multi-Link X2 ECG and SpO2 Adapter
Vyaire Medical, Inc.              510(k) NO: K191273(Traditional)
ATTN: Suzanne  Moreno             PHONE NO : 872 7570147 
26125 N. Riverwoods Blvd.         SE DECISION MADE: 13-SEP-19
Mettawa IL  60630                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Transvaginal Access Platform
Applied Medical Resources Corp.   510(k) NO: K191294(Traditional)
ATTN: Corinne  Yestrepsky         PHONE NO : 949 7138176 
22872 Avenida Empresa             SE DECISION MADE: 06-SEP-19
Rancho Santa Margarita CA  92688  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iNSitu Bipolar Hip System
Theken Companies, LLC             510(k) NO: K191297(Traditional)
ATTN: Garrett  Spurgeon           PHONE NO : 330 7337600 1632
1800 Triplett Blvd                SE DECISION MADE: 17-SEP-19
Akron OH  44306                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MectaLock Ti Suture Anchor
Medacta International SA          510(k) NO: K191300(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 12-SEP-19
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ceribell Pocket EEG Device
Ceribell, Inc.                    510(k) NO: K191301(Traditional)
ATTN: Josef  Parvizi              PHONE NO : 650 5217003 
2483 Old Middlefield Way, Suite 12SE DECISION MADE: 11-SEP-19
Mountain View CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CivaDerm
CivaTech Oncology Inc.            510(k) NO: K191324(Traditional)
ATTN: Suzanne  Babcock            PHONE NO : 919 3145515 
2810 Meridian Parkway, Suite 152  SE DECISION MADE: 20-SEP-19
Durham NC  27713                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PRECICE System
NuVasive Specialized Orthopedics, 510(k) NO: K191336(Traditional)
ATTN: Aditya  Sharma              PHONE NO : 858 4800263 
101 Enterprise, Suite 100         SE DECISION MADE: 26-SEP-19
Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900
STERIS Corporation                510(k) NO: K191343(Special)
ATTN: Jennifer  Nalepka           PHONE NO : 440 3927458 
5960 Heisley Road                 SE DECISION MADE: 05-SEP-19
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ti3Z Cervical Interbody System
Zavation Medical Products, LLC    510(k) NO: K191354(Traditional)
ATTN: Katie  Motley               PHONE NO : 601 9191119 
220 Lakeland Parkway              SE DECISION MADE: 09-SEP-19
Flowood MS  39232                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask
3M Health Care                    510(k) NO: K191355(Traditional)
ATTN: Angie  Draper               PHONE NO : 651 7331179 
3M Center, 2510 Conway Ave., BuildSE DECISION MADE: 11-SEP-19
St. Paul MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Flexible HD Cysto-Urethroscope System
KARL STORZ Endoscopy-America, Inc.510(k) NO: K191357(Traditional)
ATTN: Irina  Fedorov              PHONE NO : 508 2481275 
2151 E. Grand Avenue              SE DECISION MADE: 18-SEP-19
El Segundo CA  90245              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vacutore Air/Water Bottle Tubing
Smartdata Suzhou Co., Ltd         510(k) NO: K191366(Third Party - Traditional)
ATTN: Cindy  Ye                   PHONE NO : 86 512 65983722 
4f, Block 7, 198#, Jinshan Rd     SE DECISION MADE: 06-SEP-19
Suzhou  CN 215011                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe
Medline Industries, Inc.          510(k) NO: K191378(Traditional)
ATTN: Stephanie  Augsburg         PHONE NO : 847 6433690 
Three Lake Drive                  SE DECISION MADE: 15-SEP-19
Northfield IL  60093              510(k) STATEMENT
                                                    

DEVICE: HEDRON Lumbar Spacers
Globus Medical Inc.               510(k) NO: K191391(Traditional)
ATTN: Kelly  Baker                PHONE NO : 610 9301800 1670
2560 General Armistead Ave.       SE DECISION MADE: 18-SEP-19
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AcQMap High Resolution Imaging and Mapping System
Acutus Medical, Inc.              510(k) NO: K191392(Traditional)
ATTN: Karla  Schaffner            PHONE NO : 1 442 2326161 
2210 Faraday Ave., Suite 100      SE DECISION MADE: 06-SEP-19
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire
Rex Medical, L.P.                 510(k) NO: K191419(Traditional)
ATTN: Colin  Valentis             PHONE NO : 610 9400665 
555 East North Lane, Suite 5035   SE DECISION MADE: 12-SEP-19
Conshohocken PA  19428            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sofacia System
Sofwave Medical Ltd.              510(k) NO: K191421(Traditional)
ATTN: Ruthie  Amir                PHONE NO : 972 54 3003164 
Beit Tavor 2                      SE DECISION MADE: 09-SEP-19
Yokneam  IL                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4
Nalu Medical, Inc.                510(k) NO: K191435(Traditional)
ATTN: Michele  Chin-Purcell       PHONE NO : 760 8276461 
2320 Faraday Ave. Suite 100       SE DECISION MADE: 06-SEP-19
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir
Medtronic, Inc.                   510(k) NO: K191444(Traditional)
ATTN: Harsh  Dharamshi            PHONE NO : 763 5058646 
7611 Northland Drive              SE DECISION MADE: 27-SEP-19
Minneapolis MN  55428             510(k) STATEMENT
                                                    

DEVICE: BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)
MED-EL Elektromedizinische Geraete510(k) NO: K191457(Traditional)
ATTN: Ines Roman Santiago         PHONE NO : 43 57 7885786 
Fuestenweg 77a                    SE DECISION MADE: 18-SEP-19
Innsbruck  AT 6020                510(k) STATEMENT
                                                    

DEVICE: JuggerStitch Meniscal Repair Device
Biomet Inc.                       510(k) NO: K191459(Traditional)
ATTN: Kyle  Ponce                 PHONE NO : 973 2999300 2125
56 East Bell Drive                SE DECISION MADE: 13-SEP-19
Warsaw IN  46581                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive® ACP System
NuVasive, Incorporated            510(k) NO: K191500(Traditional)
ATTN: Jessica  Silverman          PHONE NO : 858 9093302 
7475 Lusk Blvd.                   SE DECISION MADE: 03-SEP-19
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MobileRay Pulse SE Digital Imaging System
Portavision Medical LLC           510(k) NO: K191503(Traditional)
ATTN: Terry  Ancar                PHONE NO : 866 7834133 
800 Central Avenue                SE DECISION MADE: 04-SEP-19
Jefferson LA  70121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ali Interbody Fusion System
Raed M. Ali, MD., Inc.            510(k) NO: K191516(Traditional)
ATTN: Raed  Ali                   PHONE NO : 
6 Starcatcher                     SE DECISION MADE: 12-SEP-19
Newport Coast CA  92657           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CO2 Laser System
Shenzhen GSD Tech Co., Ltd        510(k) NO: K191518(Traditional)
ATTN: Jiancheng  Zhang            PHONE NO : 86 755 29169426 
Building A Junsd Hi-Tech Park, WesSE DECISION MADE: 12-SEP-19
Shenzhen  CN 518106               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Radiance 330 Proton Beam Therapy System
ProTom International Holding Corpo510(k) NO: K191521(Traditional)
ATTN: Stephen L. Spotts           PHONE NO : 781 2453964 
500 Edgewater Place Suite 522     SE DECISION MADE: 27-SEP-19
Wakefield MA  01880               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Visalys Tooth Primer
Kettenbach GmbH & Co. KG          510(k) NO: K191524(Traditional)
ATTN: Katja  Simon                PHONE NO : 49 2774 7050 
Im Heerfeld 7                     SE DECISION MADE: 29-SEP-19
Eschenburg  DE 35713              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Venus Legacy Pro Device
Venus Concept USA Inc.            510(k) NO: K191528(Traditional)
ATTN: Yoni  Iger                  PHONE NO : 972 549599215 
1880 N Commerce Pkwy, Suite 2     SE DECISION MADE: 06-SEP-19
Weston FL  33326                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: StoneChecker
Imaging Biometrics, LLC           510(k) NO: K191530(Traditional)
ATTN: Timothy  Dondlinger         PHONE NO : 262 4398252 
13416 Watertown Plank Road, Suite SE DECISION MADE: 26-SEP-19
Elm Grove WI  53122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sure-Fine Insulin Syringes
Shina Med Corporation             510(k) NO: K191531(Special)
ATTN: Park  Sung-soon             PHONE NO : 82 31 80572125 
455-30 Bogaewonsam-ro, Bogae-myun SE DECISION MADE: 06-SEP-19
Anseong-si  KR 456-871            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: eCarbon IBDs
Back 2 Basics Direct, LLC         510(k) NO: K191537(Traditional)
ATTN: Scot  Miller                PHONE NO : 216 4475205 
6701 Rockside Road, Suite 200     SE DECISION MADE: 26-SEP-19
Independence OH  44131            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Exogenesis Hernia Mesh
Exogenesis Corporation            510(k) NO: K191545(Traditional)
ATTN: Joseph  Khoury              PHONE NO : 978 4390120 
20 Fortune Drive                  SE DECISION MADE: 26-SEP-19
Billerica MA  01821               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GM501 Mineral Oil
Hamilton Thorne Inc.              510(k) NO: K191552(Abbreviated)
ATTN: Donald  Fournier            PHONE NO : 1 978 9212050 
100 Cummings Center, Suite 465E   SE DECISION MADE: 18-SEP-19
Beverly MA  01915                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mercury® Spinal System, Overwatch® Spinal System
Spinal Elements, Inc              510(k) NO: K191576(Traditional)
ATTN: Julie  Lamothe              PHONE NO : 760 6071840 
3115 Melrose Dr. Suite 200        SE DECISION MADE: 16-SEP-19
Carlsbad CA  92010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Willow Wearable Breast Pump 2.0
Exploramed NC7, Inc.              510(k) NO: K191577(Special)
ATTN: Steve  Holmes               PHONE NO : 650 5595805 
1975 W. El Camino Real, Suite 306 SE DECISION MADE: 06-SEP-19
Mountain View CA  94040           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: L360 Thigh System
Bioness Inc.                      510(k) NO: K191587(Traditional)
ATTN: Mercedes  Bayani            PHONE NO : 661 3626690 
25103 Rye Canyon Loop             SE DECISION MADE: 12-SEP-19
Valencia CA  91355                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARCHITECT STAT High Sensitivity Troponin-I
Abbott Laboratories Diagnostics Di510(k) NO: K191595(Traditional)
ATTN: Judi  Wallach               PHONE NO : 224 6671132 
Dept. 09AA, Bldg. AP8, 100 Abbott SE DECISION MADE: 13-SEP-19
Abbott Park IL  60064-6038        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NICO Myriad NOVUS
NICO Corporation                  510(k) NO: K191599(Traditional)
ATTN: Sean  Spence                PHONE NO : 317 6607118 115
250 East 96th Street, Suite 125   SE DECISION MADE: 13-SEP-19
Indianapolis IN  46240            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neocis Guidance System (NGS)
Neocis Inc.                       510(k) NO: K191605(Traditional)
ATTN: Thomas E. Claiborne         PHONE NO : 631 7938945 
2800 Biscayne Blvd Suite 600      SE DECISION MADE: 11-SEP-19
Miami FL  33137                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Syntec Tibial Nail System
Syntec Scientific Corporation     510(k) NO: K191617(Traditional)
ATTN: Kavin  Chu                  PHONE NO : 886 4 7987099 
No.2, Kung San Road Chuan Shing InSE DECISION MADE: 03-SEP-19
Chang Hua  TW 50971               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TurboTemp EZ
Zest Anchors, LLC                 510(k) NO: K191619(Traditional)
ATTN: Marysa E. Loustalot         PHONE NO : 760 7437744 
2875 Loker Avenue East            SE DECISION MADE: 11-SEP-19
Carlsbad CA  92010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Persona Revision Knee System
Zimmer Inc.                       510(k) NO: K191625(Traditional)
ATTN: Nicole  Meredith            PHONE NO : 574 3773718 
1800 W. Center Street             SE DECISION MADE: 05-SEP-19
Warsaw IN  46580                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: faceLITE
iSMART Marketing Svcs Ltd         510(k) NO: K191629(Traditional)
ATTN: Susan  D'Arcy               PHONE NO : 44 07880 313315 
129 Green Lanes, Sutton Coldfield SE DECISION MADE: 12-SEP-19
Birmingham  GB B735LT             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws
Industrias Medicas Sampedro S.A.S 510(k) NO: K191641(Traditional)
ATTN: Liliana  Zuluaga-Idarraga   PHONE NO : 574 3223375 
Carrera 47 No. 100 Sur 40         SE DECISION MADE: 16-SEP-19
La Estrella  CO 055468            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0
Canon Medical Systems Corporation 510(k) NO: K191663(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 18-SEP-19
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intra.Ox 2.0 Handheld Tissue Oximeter
ViOptix, Inc.                     510(k) NO: K191676(Traditional)
ATTN: Scott  Coleridge            PHONE NO : 510 2265860 
39655 Eureka Drive                SE DECISION MADE: 16-SEP-19
Newark CA  94560                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Omnipod DASH Insulin Management System with interoperable technology
Insulet Corporation               510(k) NO: K191679(Traditional)
ATTN: Julie  Perkins              PHONE NO : 987 6007951 
100 Nagog Park                    SE DECISION MADE: 20-SEP-19
Acton MA  01720                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PicoWay Laser System
Candela Corporation               510(k) NO: K191685(Traditional)
ATTN: Brenda  Geary               PHONE NO : 508 9743556 
530 Boston Post Road              SE DECISION MADE: 16-SEP-19
Wayland MA  01778                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SubtleMR
Subtle Medical, Inc.              510(k) NO: K191688(Traditional)
ATTN: Ajit  Shankaranarayanan     PHONE NO : 650 3978709 
883 Santa Cruz Ave, Suite 205     SE DECISION MADE: 16-SEP-19
Menlo Park CA  94025              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FlowTriever Retrieval/Aspiration System
Inari Medical                     510(k) NO: K191710(Traditional)
ATTN: Eben  Gordon                PHONE NO : 949 6008433 
9272 Jeronimo Rd., Suite 124      SE DECISION MADE: 05-SEP-19
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Buhlmann fCAL turbo and CALEX Cap
BUHLMANN Laboratories AG          510(k) NO: K191718(Traditional)
ATTN: Laura  Zurbrugg             PHONE NO : 41 61 4871250 
Baselstrasse 55                   SE DECISION MADE: 24-SEP-19
Schonenbuch  CH 4124              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: mont blanc & mont blanc MIS Spinal Systems
Spineway SA                       510(k) NO: K191726(Traditional)
ATTN: Heloise  Macaire            PHONE NO : 33 04 72770152 
7 allee Moulin Berger             SE DECISION MADE: 12-SEP-19
Ecully  FR 69130                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARIES MRSA Assay
Luminex Corporation               510(k) NO: K191742(Traditional)
ATTN: Kate  Linak                 PHONE NO : 608 2038909 
12212 Technology Blvd             SE DECISION MADE: 25-SEP-19
Austin TX  78727                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FUJIFILM Duodenoscope Model ED-580XT
FUJIFILM Corporation              510(k) NO: K191747(Traditional)
ATTN: Randy  Vader                PHONE NO : 360 3566821 
798 Miyanodai Kaisei-Machi        SE DECISION MADE: 27-SEP-19
Ashigarakami-Gun  JP 258-8538     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Genesys Spine Sacroiliac Joint Fusion System
Genesys Spine                     510(k) NO: K191748(Traditional)
ATTN: William W. Sowers           PHONE NO : 512 3817080 
1250 South Capital of Texas HighwaSE DECISION MADE: 26-SEP-19
Austin TX  78746                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OMNI TiN Coated Apex Knee™ System
OMNI life science, Inc.           510(k) NO: K191765(Traditional)
ATTN: Christina  Rovaldi          PHONE NO : 774 2261857 
480 Paramount Drive               SE DECISION MADE: 25-SEP-19
Raynham MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SmileAlign Orthodontic Aligner System
3D Global Biotech Inc.            510(k) NO: K191774(Traditional)
ATTN: Keng-Liang  Ou              PHONE NO : 886 2 26971270 
21F.-1, No.99, Sec. 1, Xintai 5th SE DECISION MADE: 30-SEP-19
New Taipei City 221  TW           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TTC Phantom Intramedullary Nail System
Paragon 28, Inc.                  510(k) NO: K191782(Special)
ATTN: Eric  Lintula               PHONE NO : 888 7281888 
4B Inverness Ct. E., STE 280      SE DECISION MADE: 06-SEP-19
Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TranS1 Interbody Fusion System
TranS1                            510(k) NO: K191791(Traditional)
ATTN: Kristen  Allen              PHONE NO : 888 5261879 
3804 Park Avenue, Suite C         SE DECISION MADE: 25-SEP-19
Wilmington NC  28403              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim
Kossan International Sdn. Bhd.    510(k) NO: K191800(Traditional)
ATTN: Cho Sow Fong                PHONE NO : 603 3 2910516 
Wisma Kossan, Lot 782, Jalan SungaSE DECISION MADE: 16-SEP-19
Klang  MY 42100                   510(k) STATEMENT
                                                    

DEVICE: PROBEAT-CR
Hitachi Ltd.                      510(k) NO: K191801(Traditional)
ATTN: Tomoyuki  Seino             PHONE NO : 81 294 555900 
3-1-1, Saiwai-cho                 SE DECISION MADE: 13-SEP-19
Hitachi-shi  JP 317-8511          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Catalyst OrthoScience CSR Shoulder System
Catalyst OrthoScience, Inc.       510(k) NO: K191811(Special)
ATTN: Dale  Davison               PHONE NO : 239 3259976 102
14710 Tamiami Trail North, Suite 1SE DECISION MADE: 11-SEP-19
Naples FL  34110                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Discovery Pico, Discovery Pico Plus, Discovery Pico Derm
Quanta System, S.p.A.             510(k) NO: K191842(Traditional)
ATTN: Francesco  Dell’Antonio     PHONE NO : 39 0331 376797 
Via Acquedotto, 109               SE DECISION MADE: 17-SEP-19
Samarate  IT 20826                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fidmi Low Profile Enteral Feeding Device
Fidmi Medical Ltd                 510(k) NO: K191844(Traditional)
ATTN: Shahar  Millis              PHONE NO : 972 77 3628362 
5 Haeshel St.                     SE DECISION MADE: 30-SEP-19
Caesarea Business Park, Caesarea  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)
Barco NV                          510(k) NO: K191845(Traditional)
ATTN: Julie  Vandecandelaere      PHONE NO : 32 56 262319 
President Kennedypark 35          SE DECISION MADE: 06-SEP-19
Kortrijk  BE 8500                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: APTUS Wrist Spanning Plates 2.5
Medartis AG                       510(k) NO: K191848(Traditional)
ATTN: Andrea  Schweizer           PHONE NO : 41 61 6333434 
Hochbergerstrasse 60E             SE DECISION MADE: 30-SEP-19
Basel  CH CH-4057                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dual-Safety Pen Needle
Promisemed Hangzhou Meditech Co., 510(k) NO: K191853(Traditional)
ATTN: Zearou  Yang                PHONE NO : 865 718 8772985 
Bldg. 1, No. 12, Longtan Road, CanSE DECISION MADE: 05-SEP-19
Hangzhou City  CN                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MTS Imipenem 0.016-256 µg/mL
Liofilchem s.r.l.                 510(k) NO: K191908(Traditional)
ATTN: Fabio  Brocco               PHONE NO : 39 085 8930745 
Via Scozia zona ind.le            SE DECISION MADE: 04-SEP-19
Roseto degli Abruzzi  IT 64026    510(k) STATEMENT
                                                    

DEVICE: Hinged Laminoplasty System
Life Spine, Inc.                  510(k) NO: K191927(Traditional)
ATTN: Angela  Batker              PHONE NO : 847 8846117 
13951 S Quality Drive             SE DECISION MADE: 20-SEP-19
Huntley IL  60142                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens
UNICON Optical CO., LTD           510(k) NO: K191929(Traditional)
ATTN: Hsiao-Wei  Shen             PHONE NO : 886 3 5775586 
No 16, Gongye E. 9th Rd. Hsinchu SSE DECISION MADE: 17-SEP-19
Hsinchu County  TW 30075          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KOWA nonmyd 8
Kowa Company, Ltd.                510(k) NO: K191945(Traditional)
ATTN: Nariaki  Morita             PHONE NO : 81 42 4407612 
3-1, Chofugaoka 3-Chome           SE DECISION MADE: 10-SEP-19
Chofu  JP 1820021                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord
Maquet Cardiovascular, LLC.       510(k) NO: K191947(Traditional)
ATTN: Mark  Dinger                PHONE NO : 973 7097691 
45 Barbour Pond Drive             SE DECISION MADE: 17-SEP-19
Wayne NJ  07470                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UNFOLDER Vitan Inserter
Johnson & Johnson Surgical Vision,510(k) NO: K191949(Abbreviated)
ATTN: Silvia  Jiang-Hughes        PHONE NO : 714 2478714 
1700 East Saint Andrew Place      SE DECISION MADE: 13-SEP-19
Santa Ana CA  92705               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mako Total Hip Application, Mako Total Knee Application
MAKO Surgical Corp.               510(k) NO: K191998(Traditional)
ATTN: Shikha  Khandelwal          PHONE NO : 201 8316921 
2555 Davie Road                   SE DECISION MADE: 24-SEP-19
Fort Lauderdale FL  33317         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SmoothSkin BARE+
CyDen Limited                     510(k) NO: K192010(Special)
ATTN: Adam  Stephens              PHONE NO : 44 01792 274009 
Block A, Bay Studios Business ParkSE DECISION MADE: 24-SEP-19
Swansea  GB SA1 8QB               510(k) STATEMENT
                                                    

DEVICE: PhoeniX
Sedecal, SA.                      510(k) NO: K192011(Abbreviated)
ATTN: Mª Luisa  Gomez de Aguero   PHONE NO : 34 91 6280544 
C/Pelaya, 9 -13 Pol. Ind. Rio de JSE DECISION MADE: 25-SEP-19
Algete  ES 28110                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Capillus 112, Capillus 244
Capillus                          510(k) NO: K192012(Special)
ATTN: Patricia  Schnoor           PHONE NO : 786 8881874 
1715 NW 82nd Ave.                 SE DECISION MADE: 12-SEP-19
Doral FL  33126                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label
STERIS Corporation                510(k) NO: K192020(Special)
ATTN: Gregory  Land               PHONE NO : 440 3927424 
5960 Heisley Road                 SE DECISION MADE: 05-SEP-19
Mentor OH  44077                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RS80 EVO Diagnostic Ultrasound System
Samsung Medison Co., Ltd.         510(k) NO: K192030(Traditional)
ATTN: Ji Yea Lee                  PHONE NO : 82 2 21941594 
3366, Hanseo-ro, Nam-myeon,       SE DECISION MADE: 19-SEP-19
Hongcheon-gun  KR 25108           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Advisor VL Circular Mapping Catheter, Sensor Enabled
Abbott Medical                    510(k) NO: K192037(Traditional)
ATTN: Tamara L. Stanczak          PHONE NO : 651 7566656 
5050 Nathan Lane North            SE DECISION MADE: 17-SEP-19
Plymouth MN  55442                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)
bioMerieux SA                     510(k) NO: K192050(Traditional)
ATTN: Marine  Taravant            PHONE NO : 33 04 78872126 
376 Chemin de l’Orme              SE DECISION MADE: 27-SEP-19
Marcy-l’Etoile  FR 69280          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bio Guard Air/Water & Suction Valves
United States Endoscopy Group, Inc510(k) NO: K192059(Special)
ATTN: Carroll  Martin             PHONE NO : 440 3586259 
5976 Heisley Road                 SE DECISION MADE: 17-SEP-19
Mentor OH  44060                  510(k) STATEMENT
                                                    

DEVICE: GOLNIT Non-aborbable PTFE Surgical Suture
Antarma LLC dba Golnit Sutures    510(k) NO: K192088(Special)
ATTN: Armine  Badalyan            PHONE NO : 718 2190731 
276 5th Ave., Suite 704           SE DECISION MADE: 04-SEP-19
New York NY  10001                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Thermoplastic Masks
Aktina Medical Corporation        510(k) NO: K192102(Traditional)
ATTN: Tony  Spaccarotella         PHONE NO : 845 2680101 18
360 North Route 9W                SE DECISION MADE: 25-SEP-19
Congers NY  10920                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AcQRef Introducer Sheath
Acutus Medical, Inc.              510(k) NO: K192106(Special)
ATTN: Serena  Sanginthirath       PHONE NO : 1 442 2326178 
2210 Faraday Ave., Suite 100      SE DECISION MADE: 03-SEP-19
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FlexBand Plus
International Life Sciences       510(k) NO: K192112(Special)
ATTN: Tiffini  Wittwer            PHONE NO : 707 7996732 
2252 Northwest Parkway SE         SE DECISION MADE: 27-SEP-19
Marietta GA  30067                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Human IgA liquid reagent kit for Use on SPAPlus
The Binding Site Group Ltd        510(k) NO: K192116(Special)
ATTN: Natasha  Verhaak            PHONE NO : 44 0121 4569500 
8 Calthorpe Road Edgbaston        SE DECISION MADE: 04-SEP-19
Birmingham  GB B15 1QT            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M Clarity Aligners
3M Company                        510(k) NO: K192119(Third Party - Traditional)
ATTN: Yanine  Garcia-Quezada      PHONE NO : 651 7368238 
2510 Conway Avenue                SE DECISION MADE: 05-SEP-19
St. Paul MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream
Qingdao Hightop Biotech Co., Ltd. 510(k) NO: K192123(Traditional)
ATTN: Allen  Lee                  PHONE NO : 86 0532 58710705 
No. 369 Hedong Road, Hi-tech IndusSE DECISION MADE: 05-SEP-19
Qingdao  CN 266112                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens
Clearlab SG Pte, Ltd              510(k) NO: K192129(Special)
ATTN: John Christopher Phelan     PHONE NO : 65 6749 1090 
139 Joo Seng Road #01-01          SE DECISION MADE: 27-SEP-19
Singapore  SG 368362              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Freedom Primary PCK
Maxx Orthopedics, Inc.            510(k) NO: K192148(Special)
ATTN: Priscilla  Herpai           PHONE NO : 484 3420092 
2460 General Armistead Ave. Suite SE DECISION MADE: 05-SEP-19
Norristown PA  19403              510(k) STATEMENT
                                                    

DEVICE: Smith & Nephew DYONICS 25 Fluid Management System
Smith & Nephew, Inc.              510(k) NO: K192155(Special)
ATTN: Bryan  Cowell               PHONE NO : 978 7491093 
150 Minuteman Road                SE DECISION MADE: 04-SEP-19
Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cartiva SCI instrumentation set
Cartiva, Inc.                     510(k) NO: K192156(Special)
ATTN: Shriya  Kafle               PHONE NO : 770 7543800 
6120 Windward Parkway, Suite 220  SE DECISION MADE: 04-SEP-19
Alpharetta GA  30005              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVO Platform
Quanta System, S.p.A              510(k) NO: K192160(Special)
ATTN: Francesco  Dell'Antonio     PHONE NO : 39 033 1376797 
Via Acquedotto, 109               SE DECISION MADE: 06-SEP-19
Samarate  IT 20826                510(k) STATEMENT
                                                    

DEVICE: Connected OR Hub with Device and Voice Control
Stryker                           510(k) NO: K192172(Special)
ATTN: Meagan  Jones               PHONE NO : 214 7012186 
5900 Optical Court                SE DECISION MADE: 09-SEP-19
San Jose CA  95131                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aquilion ONE (TSX-306A/3) V10.0
Canon Medical Systems Corporation 510(k) NO: K192188(Special)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 06-SEP-19
Otawara-Shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Dilator
Galt Medical Corp.                510(k) NO: K192195(Special)
ATTN: David  Derrick              PHONE NO : 972 2715177 
2220 Merritt Dr.                  SE DECISION MADE: 26-SEP-19
Garland TX  75041                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CRC PC Smart Chamber K1
Capintec, Inc.                    510(k) NO: K192199(Special)
ATTN: Mary Anne Yusko             PHONE NO : 201 8259500 312
7 Vreeland Road                   SE DECISION MADE: 12-SEP-19
Florham Park NJ  07932            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NCB Plating System Distal Femur and Proximal Tibia
Zimmer GmbH                       510(k) NO: K192217(Special)
ATTN: Annemie Rehor Kausch        PHONE NO : 41 58 8548261 
Sulzerallee 8                     SE DECISION MADE: 13-SEP-19
Winterthur  CH 8404               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lumify Diagnostic Ultrasound System
Philips Healthcare                510(k) NO: K192226(Third Party - Traditional)
ATTN: Paul  Elias                 PHONE NO : 425 4828396 
22100 Bothell Everett Highway     SE DECISION MADE: 06-SEP-19
Bothell WA  98021-8431            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ProPerformance Recovery System
Menlo Brands LLC                  510(k) NO: K192252(Third Party - Traditional)
ATTN: Sam  Chi                    PHONE NO : 650 7968905 
2045 Avy Avenue                   SE DECISION MADE: 19-SEP-19
Menlo Park CA  94025              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: InnoSight Diagnostic Ultrasound System
Qisda Corporation                 510(k) NO: K192254(Third Party - Traditional)
ATTN: Johnson  Sheu               PHONE NO : 
No.157, Shanying Rd, Shan-Ting Li,SE DECISION MADE: 18-SEP-19
Taoyuan  TW                       510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Philips IntelliSite Pathology Solution
Philips Electronics Nederland B.V.510(k) NO: K192259(Special)
ATTN: Liselotte  Kornmann         PHONE NO : 31 6 11621238 
Veenpluis 6                       SE DECISION MADE: 20-SEP-19
Best  NL 5684 PC                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Merge Cardio
Merge Healthcare Incorporated     510(k) NO: K192276(Traditional)
ATTN: Lisa  Baumhardt             PHONE NO : 262 3693364 
900 Walnut Ridge Drive            SE DECISION MADE: 20-SEP-19
Hartland WI  53209                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: uDR 592h, uDR 596i
Shanghai United Imaging Healthcare510(k) NO: K192293(Special)
ATTN: Xin  Gao                    PHONE NO : 86 021 67076888 5386
No. 2258 Chengbei Road,           SE DECISION MADE: 12-SEP-19
Shanghai  CN 201807               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medtronic 6F Taiga Guiding Catheter
Medtronic Vascular                510(k) NO: K192296(Special)
ATTN: Colleen  Mullins            PHONE NO : 978 7393267 
37a Cherry Hill Drive             SE DECISION MADE: 20-SEP-19
Danvers MA  01923                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip
Shenzhen Bioeasy Biotechnology Co.510(k) NO: K192301(Traditional)
ATTN: Wenhau  Yan                 PHONE NO : 86 755 27948546 
No.2-1,Liuxian 1st Road,Xin'an SubSE DECISION MADE: 20-SEP-19
Shenzhen  CN 518101               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SIS Software Version 3.6.0
Surgical Information Sciences, Inc510(k) NO: K192304(Special)
ATTN: Ann  Quinlan-Smith          PHONE NO : 612 3250187 
10405 6th Avenue North, Suite 110 SE DECISION MADE: 13-SEP-19
Plymouth MN  55441                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: T-Stat 2.0 Microvascular Tissue Oximeter
Spectros Corporation              510(k) NO: K192322(Special)
ATTN: Bill  Curnan                PHONE NO : 650 8514040 
274 E Hamilton Ave Suite H        SE DECISION MADE: 23-SEP-19
Campbell CA  95008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HardyDisk AST Lefamulin 20µg (LMU20)
Hardy Diagnostics                 510(k) NO: K192326(Traditional)
ATTN: Anna  Klavins               PHONE NO : 800 2662222 5752
1430 West McCoy Lane              SE DECISION MADE: 19-SEP-19
Santa Maria CA  93455             510(k) STATEMENT
                                                    

DEVICE: ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath
Inari Medical                     510(k) NO: K192332(Special)
ATTN: Eben  Gordon                PHONE NO : 949 6008433 
9272 Jeronimo Rd., Suite 124      SE DECISION MADE: 20-SEP-19
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sapphire NC Plus Coronary Dilatation Catheter
OrbusNeich Medical Trading Inc.   510(k) NO: K192344(Special)
ATTN: John  Pazienza              PHONE NO : 954 7300711 
5363 NW 35th Avenue               SE DECISION MADE: 19-SEP-19
Fort Lauderdale FL  33309         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MiniMAX
Medacta International SA          510(k) NO: K192352(Special)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 27-SEP-19
Castel San Pietro  CH ch-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Innovasis Gibralt Spine System
Innovasis, Inc.                   510(k) NO: K192354(Special)
ATTN: Marshall  McCarthy          PHONE NO : 801 2612236 
614 East 3900 South               SE DECISION MADE: 24-SEP-19
Salt Lake City UT  84107          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GXR-Series Diagnostic X-Ray System
DRGEM Corporation                 510(k) NO: K192364(Traditional)
ATTN: Ki-Nam  Yang                PHONE NO : 82 2 8698566 
7F E-B/D Gwangmyeong Techno-Park 6SE DECISION MADE: 26-SEP-19
Gwangmyeong-si  KR 14322          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CATSmart
Fresenius Kabi AG                 510(k) NO: K192368(Special)
ATTN: Shane  Sawall               PHONE NO : 49 6172 6860 
Else-Kroner-Strasse 1             SE DECISION MADE: 27-SEP-19
Bad Homburg  DE 61352             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioZorb SP Marker
Focal Therapeutics                510(k) NO: K192371(Special)
ATTN: Dhaval  Saraiya             PHONE NO : 408 9627010 
1010 Stewart Drive                SE DECISION MADE: 26-SEP-19
Sunnyvale CA  94085               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spectralis HRA+OCT and Variants
Heidelberg Engineering GmbH       510(k) NO: K192391(Special)
ATTN: Arianna Schoess Vargas      PHONE NO : 49 6221 64630 
Max-Jarecki-Strasse 8             SE DECISION MADE: 26-SEP-19
Heidelberg  DE 69115              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo.CT Extended Functionality
Siemens Medical Solutions USA, Inc510(k) NO: K192402(Special)
ATTN: Alaine  Medio               PHONE NO : 865 2060337 
810 Innovation Drive              SE DECISION MADE: 20-SEP-19
Knoxville TN  37932               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EpiFaith Syringe
Flat Medical Co., Ltd             510(k) NO: K192421(Special)
ATTN: Shao Wei  Tseng             PHONE NO : 886 225672 959 13
9F-1., No27, Sec.1, Chang' An E. RSE DECISION MADE: 27-SEP-19
Taipei  TW 10441                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hair Boom 69, Hair Boom Air, Ulike Hair UpUp
Won Tech Co., Ltd.                510(k) NO: K192425(Special)
ATTN: Jake  Yu                    PHONE NO : 82 707836 6921 
64 Techno 8-Ro, Yuseong-gu        SE DECISION MADE: 30-SEP-19
Daejeon  KR 34028                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive NuvaLine
NuVasive, Incorporated            510(k) NO: K192435(Third Party - Traditional)
ATTN: Manthan  Damani             PHONE NO : 858 9091800 
7475 Lusk Boulevard               SE DECISION MADE: 26-SEP-19
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW


          TOTAL 510(k)s THIS PERIOD   237                                     
          TOTAL WITH SUMMARIES        222                                     
          TOTAL WITH STATEMENTS        15