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  1. 510(k) Clearances

February 2020 510(K) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD February 2020


DEVICE: Infinity / Infinity Cross Flex Dental Systems
Olsen Insdustria de Equipamentos O510(k) NO: K180935(Traditional)
ATTN: Ana Claudia Espindola       PHONE NO : 55 19 38179633 
Av. Ivo Luchi, 68 - Jardim EldoradSE DECISION MADE: 05-FEB-20
Palhoça -  BR 88133-510           510(k) STATEMENT
                                                    

DEVICE: Pulmonary Cytology Brush
Hobbs Medical, Inc.               510(k) NO: K182927(Traditional)
ATTN: Carlos O. Acosta            PHONE NO : 860 8519842 
8 Spring Street                   SE DECISION MADE: 07-FEB-20
Stafford Springs CT  06076        510(k) STATEMENT
                                                    

DEVICE: Implacil Implant System
Implacil de Bortoli Material Odont510(k) NO: K183024(Traditional)
ATTN: Thiago  Toni                PHONE NO : 55 11 33425100 
Rua Vicente de Carvalho 178-182   SE DECISION MADE: 13-FEB-20
Sao Paulo  BR 01521020            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OKLand Patient Return Electrode Pad
Auckland Medical Polymer(Tianjin) 510(k) NO: K183148(Traditional)
ATTN: Bei Lei Gao                 PHONE NO : 86 151 22456760 
Building D5-2, XEDA International SE DECISION MADE: 04-FEB-20
Tianjin  CN 300385                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: i-STAT CHEM8+ cartridge with the i-STAT 1 System
Abbott point of Care, Inc.        510(k) NO: K183678(Traditional)
ATTN: Susan  Tibedo               PHONE NO : 609 4549360 
400 College Road East             SE DECISION MADE: 07-FEB-20
Princeton NJ  08540               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: i-STAT CHEM8+ cartridge with the i-STAT 1 System
Abbott Point of Care Inc.         510(k) NO: K183680(Traditional)
ATTN: Susan  Tibedo               PHONE NO : 609 4549360 
400 College Road East             SE DECISION MADE: 28-FEB-20
Princeton NJ  08540               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: i-STAT CHEM8+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.        510(k) NO: K183688(Traditional)
ATTN: Susan  Tibedo               PHONE NO : 609 4549360 
400 College Road East             SE DECISION MADE: 07-FEB-20
Princeton NJ  08540               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Sclerotherapy Needle
Hangzhou AGS MedTech CO., Ltd     510(k) NO: K190032(Traditional)
ATTN: Xiangyong  Yu               PHONE NO : 86 571 87671223 
Building 5, Building 6, Kangxin RoSE DECISION MADE: 27-FEB-20
Hangzhou  CN 310000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: K3Pro Konus New Abutments and Implants
Argon Med. Productions Vertriebs G510(k) NO: K190192(Traditional)
ATTN: Richard  Donaca             PHONE NO : 49 6721 30960 
Franz-Kirsten-Str. 1              SE DECISION MADE: 10-FEB-20
Bingen Am Rhein  DE 55411         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vesta RF Cannula
Biomerics                         510(k) NO: K190259(Special)
ATTN: Jake  Wakley                PHONE NO : 801 3552705 
6030 West Harold Gatty Drive      SE DECISION MADE: 07-FEB-20
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kingon P2 Oxygen Concentrator
Qingdao Kingon Medical Science and510(k) NO: K190304(Traditional)
ATTN: Roman  Huang                PHONE NO : 532 86767095 
24th East Building, No. 252 Yanhe SE DECISION MADE: 29-FEB-20
Qingdao  CN                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage
Omnia Medical, LLC                510(k) NO: K190363(Traditional)
ATTN: Troy  Schifano              PHONE NO : 304 4134851 
6 Canyon Rd Suite 300             SE DECISION MADE: 21-FEB-20
Morgantown WV  26508              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SDS2.2 dental implant
SDS Swiss Dental Solutions AG     510(k) NO: K190406(Traditional)
ATTN: Martin  Chares              PHONE NO : 41 715 563670 
Konstanzerstrasse 11              SE DECISION MADE: 20-FEB-20
Kreuzlingen  CH 8280              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InPen Dose Calculator
Companion Medical, Inc.           510(k) NO: K190487(Traditional)
ATTN: Jasper  Benke               PHONE NO : 858 5220252 
11011 Via Frontera, Suite D       SE DECISION MADE: 18-FEB-20
San Diego CA  92127               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AR_N SLA Type Implant System
Biotem Co., Ltd.                  510(k) NO: K190641(Traditional)
ATTN: Hong Koo Yeo                PHONE NO : 82 70 82204934 
422 Sasang-ro, Sasang-gu          SE DECISION MADE: 21-FEB-20
Busan  KR 46925                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Explorer Mini
Permobil AB                       510(k) NO: K190682(Traditional)
ATTN: Ivan  Fernandez             PHONE NO : 800 7360925 
Box 120 S-861 23                  SE DECISION MADE: 27-FEB-20
Timra  SE                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors
Cosmed Srl                        510(k) NO: K190800(Traditional)
ATTN: Andrea  Duca                PHONE NO : 39 06 9315492 
Vi dei Piani di Monte Savello 37, SE DECISION MADE: 06-FEB-20
Rome  IT 0041                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Flowart
ASSET MEDIKAL TASARIM A.S.        510(k) NO: K190806(Traditional)
ATTN: Ebru  Sirali                PHONE NO : 902 124942727 
Marmara San. Sit. M Blok No: 7-A, SE DECISION MADE: 20-FEB-20
Istanbul  TR 34303                510(k) STATEMENT
                                                    

DEVICE: Comus Locking Plate systems
Jiangsu Trauhui Medical Instrument510(k) NO: K190842(Traditional)
ATTN: Zhou  Yu                    PHONE NO : 086 519 88769966 
No.2 Longqing Road, Wujin Hi-Tech SE DECISION MADE: 03-FEB-20
Changzhou  CN 213168              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XenoSure Biologic Patch
LeMaitre Vascular                 510(k) NO: K190882(Traditional)
ATTN: John N. Bradsher            PHONE NO : 781 4251685 
63 Second Avenue                  SE DECISION MADE: 13-FEB-20
Burlington MA  01803              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ArtiSential Bipolar Fenestrated Forceps
Livsmed Inc.                      510(k) NO: K190909(Traditional)
ATTN: Dong Wook Lee               PHONE NO : 82 70 42827652 
#304, D-dong, 700, Pangyo-ro, BundSE DECISION MADE: 13-FEB-20
Seongnam-si  KR 13516             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ST Internal Implant System
T-Plus Implant Tech. Co., Ltd.    510(k) NO: K190919(Traditional)
ATTN: Dana  Cheng                 PHONE NO : 886 2 22981950 
No.41, Wuquan 6th Rd., Wugu Dist. SE DECISION MADE: 27-FEB-20
New Taipei County  TW 24889       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bella-mu
U-Needle B.V.                     510(k) NO: K190962(Traditional)
ATTN: Gert  Veldhuis              PHONE NO : 31 6 43010203 
De Veldmaat 10                    SE DECISION MADE: 03-FEB-20
Enschede  NL 7522 NM              510(k) STATEMENT
                                                    

DEVICE: Katalyst Training System
Katalyst Inc.                     510(k) NO: K190966(Traditional)
ATTN: Bjoern  Woltermann          PHONE NO : 206 4883939 
316 Occidental Ave. South Suite B3SE DECISION MADE: 03-FEB-20
Seattle WA  98104                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer
Life Technologies Corporation     510(k) NO: K191030(Traditional)
ATTN: Darcie  Baynes              PHONE NO : 858 8372891 
5781 Van Allen Way                SE DECISION MADE: 21-FEB-20
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CAPENERGY - C100, C200, C300, C400, C50
Capenergy Medical SL              510(k) NO: K191202(Traditional)
ATTN: Pilar  Sanchez              PHONE NO : 0034 93 4774348 
Avinguda Mare de Deu de MontserratSE DECISION MADE: 11-FEB-20
Sant Joan Despi, Barcelona  ES 089510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Leltek Ultrasound Imaging System
Leltek Inc                        510(k) NO: K191235(Traditional)
ATTN: Kiefe  Chang                PHONE NO : 886 2 29137577 
6F-3., No. 293, Sec. 1, Beixin Rd.SE DECISION MADE: 12-FEB-20
New Taipei City  TW 23147         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)
Chalice Medical Ltd               510(k) NO: K191246(Traditional)
ATTN: Carol  Middleton            PHONE NO : 44 1909 470777 
Manton Wood Enterprise Park,      SE DECISION MADE: 28-FEB-20
Worksop  GB S80 2RS               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ancora Nerve Block Catheter Set
Ancora Medical Technology         510(k) NO: K191290(Traditional)
ATTN: Chunyuan  Qiu               PHONE NO : 650 8592203 
333 Ravenswood Ave                SE DECISION MADE: 06-FEB-20
Menlo Park CA  94025              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: i-STAT CHEM8+ cartridge with the i-STAT 1 System
Abbott Point of Care Inc.         510(k) NO: K191298(Traditional)
ATTN: Susan  Tibedo               PHONE NO : 609 4549360 
400 College Road East             SE DECISION MADE: 07-FEB-20
Princeton NJ  08540               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Unity Subcutaneous Infusion System for Remodulin
DEKA Research & Development       510(k) NO: K191313(Traditional)
ATTN: Jason  Demers               PHONE NO : 603 6695139 
340 Commercial Street             SE DECISION MADE: 21-FEB-20
Manchester NH  03101              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)
Blackrock Microsystems            510(k) NO: K191346(Traditional)
ATTN: Rachelle  Frischknecht      PHONE NO : 801 5825533 
630 Komas Drive, Suite 200        SE DECISION MADE: 14-FEB-20
Salt Lake City UT  84108          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Paragon XHD Diagnostic Ultrasound System
Shenzhen Wisonic Medical Technolog510(k) NO: K191347(Traditional)
ATTN: Jiang  Xiaosan              PHONE NO : 8675 5860 077888087 
1st, 2nd & 5th Floor, No. 6 BuildiSE DECISION MADE: 07-FEB-20
Shenzhen  CN 518055               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: i-STAT CHEM8+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.        510(k) NO: K191360(Traditional)
ATTN: Susan  Tibedo               PHONE NO : 609 4549360 
400 College Road East             SE DECISION MADE: 14-FEB-20
Princeton NJ  08540               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01
Fujimori Kogyo Co., Ltd.          510(k) NO: K191364(Traditional)
ATTN: Jeffrey  Dahlen             PHONE NO : 619 7420203 
Shinjuku First West 1-23-7 Nishi-SSE DECISION MADE: 14-FEB-20
Shinjuku, Tokyo  JP 160-0023      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Allcem Veneer APS
Dentscare Ltda                    510(k) NO: K191389(Traditional)
ATTN: Roberta  Uyara              PHONE NO : 55 47 34416131 
Av. Edgar Nelson Meister, 474     SE DECISION MADE: 25-FEB-20
Joinville  BR 89219-501           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Heater-Cooler System 3T
LivaNova Deutschland GmbH         510(k) NO: K191402(Traditional)
ATTN: Scott  Light                PHONE NO : 49 89 323010 
Lindberghstrasse 25               SE DECISION MADE: 25-FEB-20
Munich  DE 80939                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Novalung System
Fresenius Medical Care Renal Thera510(k) NO: K191407(Traditional)
ATTN: Denise  Oppermann           PHONE NO : 781 9969103 
920 Winter Street                 SE DECISION MADE: 21-FEB-20
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ah!Yes Ob Coco Personal Lubricant
Bio-Tech Lubricants Ltd           510(k) NO: K191411(Traditional)
ATTN: Sarah  Brooks               PHONE NO : 44 0 3450941141 
C/O Epsilon House, Enterprise RoadSE DECISION MADE: 06-FEB-20
Southampton  GB SO16 7NS          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack
Caldera Medical, Inc.             510(k) NO: K191416(Traditional)
ATTN: Vicki  Gail                 PHONE NO : 818 4837602 
5171 Clareton Drive               SE DECISION MADE: 07-FEB-20
Agoura Hills CA  91301            510(k) STATEMENT
                                                    

DEVICE: Cervitec F
Ivoclar Vivadent, AG              510(k) NO: K191453(Traditional)
ATTN: Sandra  Cakebread           PHONE NO : 423 235 3535 
Bendererstrasse 2                 SE DECISION MADE: 11-FEB-20
Schaan  LI FL-9494                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Proov Test
MFB Fertility, Inc.               510(k) NO: K191462(Traditional)
ATTN: Amy  Beckley                PHONE NO : 
999 Sumner Way                    SE DECISION MADE: 27-FEB-20
Erie CO  80516                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DePuy Synthes Hammertoe Continuous Compression Implant
Synthes (USA) Products, LLC       510(k) NO: K191463(Traditional)
ATTN: Keith  Knapp                PHONE NO : 610 7195942 
1301 Goshen Parkway               SE DECISION MADE: 26-FEB-20
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton)
Fresenius Medical Care Renal Thera510(k) NO: K191474(Traditional)
ATTN: Denise  Oppermann           PHONE NO : 781 9969103 
920 Winter Street                 SE DECISION MADE: 24-FEB-20
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CareStart Flu A&B Plus
Access Bio, Inc.                  510(k) NO: K191514(Dual Track)
ATTN: Sang Joon Han               PHONE NO : 732 8734040 
65 Clyde Road, Suite A.           SE DECISION MADE: 18-FEB-20
Somerset NJ  08873                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: da Vinci Xi Surgical System, da Vinci X Surgical System
Intuitive Surgical                510(k) NO: K191529(Traditional)
ATTN: Brandon  Hansen             PHONE NO : 408 7182059 
1266 Kifer Road                   SE DECISION MADE: 06-FEB-20
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The Caterpillar and Caterpillar Micro Arterial Embolization Devices
C. R. Bard, Inc.                  510(k) NO: K191532(Traditional)
ATTN: Melanie  Hadlock            PHONE NO : 480 3506083 
Moyne Upper                       SE DECISION MADE: 04-FEB-20
Emniscorthy  IE                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biatain Silicone Ag
Coloplast A/S                     510(k) NO: K191536(Traditional)
ATTN: Kimberly  Tokach            PHONE NO : 612 7592205 
Holtedam 1                        SE DECISION MADE: 21-FEB-20
Humlebaek  DK 3050                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length
Ethicon Endo-Surgery, LLC         510(k) NO: K191555(Traditional)
ATTN: Nathan  Anderson            PHONE NO : 787 2726144 
475 Calle C                       SE DECISION MADE: 28-FEB-20
Guaynabo PR  00969                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Red Dot
Behold.AI Technologies Limited    510(k) NO: K191556(Traditional)
ATTN: Simon  Rasalingham          PHONE NO : 
91-97 Bohemia Road                SE DECISION MADE: 28-FEB-20
St. Leonards-On-Sea  GB TN37 6RJ  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UV Radiation Treatment System
Xuzhou Yongkang Electronic Science510(k) NO: K191571(Traditional)
ATTN: Kai  Li                     PHONE NO : 86 516 87892766 601
4F Building C8, 40 Jingshan Road, SE DECISION MADE: 06-FEB-20
Xuzhou  CN 221000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Beamscan MR
PTW-Freiburg Physikalisch-Technisc510(k) NO: K191646(Traditional)
ATTN: Sandor-Csaba  Ats           PHONE NO : 49 761 49055896 
Dr. Pychlau GmbH Loerracher Str. 7SE DECISION MADE: 21-FEB-20
Freiburg  DE 79115                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EleGARD Patient Positioning System
Minnesota Resuscitation Solutions,510(k) NO: K191689(Traditional)
ATTN: Philip  Tetzlaff            PHONE NO : 763 2593722 
5201 Eden Ave., Suite 300         SE DECISION MADE: 13-FEB-20
Edina MN  55436                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cardiac Monitor 1500
Zynex Medical, Inc.               510(k) NO: K191697(Traditional)
ATTN: Thomas  Sandgaard           PHONE NO : 303 7034906 
9995 Maroon Circle                SE DECISION MADE: 21-FEB-20
Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: X-MIND Trium
de Gotzen S.R.L                   510(k) NO: K191719(Traditional)
ATTN: Dario  Bandiera             PHONE NO : 39 0331 376760 
via Roma, 45                      SE DECISION MADE: 20-FEB-20
Olgiate Olona  IT 21057           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ULTepap Expiratory Positive Airway Pressure (EPAP) Device
Bryggs Medical, LLC               510(k) NO: K191728(Traditional)
ATTN: Geoffrey  Sleeper           PHONE NO : 216 8706990 
34910 Commerce Way                SE DECISION MADE: 21-FEB-20
Avon OH  44011                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The Graft Bone Substitute
Purgo Biologics Inc.              510(k) NO: K191737(Traditional)
ATTN: Eun Ho Kim                  PHONE NO : 82 2 5494635 
E-607, 700, Pangyo-ro Bundang-gu  SE DECISION MADE: 14-FEB-20
Seongnam-si  KR 13516             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DORO LUCENT® iXI and iMRI Headrest System
Pro Med Instruments GmbH          510(k) NO: K191740(Traditional)
ATTN: Sandra  Untenberger         PHONE NO : 49 076 138422210 
Boetzinger Str. 38                SE DECISION MADE: 21-FEB-20
Freiburg  DE 79111                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Orion LifeSpan MEG
Compumedics Limited               510(k) NO: K191785(Traditional)
ATTN: William  Alam               PHONE NO : 61 3 84207300 
30-40 Flockhart Street            SE DECISION MADE: 14-FEB-20
Abbotsford  AU 3067               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vathin Video Bronchoscope System
Hunan Vathin Medical Instrument Co510(k) NO: K191828(Traditional)
ATTN: Yun  Feng                   PHONE NO : 86 180 17856052 
1/F, Building 12, No 9 Chuanqi wesSE DECISION MADE: 13-FEB-20
Xiangtan  CN 411100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Microlife Non-Contact Infrared Forehead Thermometer
Microlife Intellectual Property Gm510(k) NO: K191829(Traditional)
ATTN: Gerhard  Frick              PHONE NO : 41 717 277000 
Espenstrasse 139                  SE DECISION MADE: 13-FEB-20
Widnau  CH 9443                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223)
Kurin, Inc                        510(k) NO: K191832(Traditional)
ATTN: Neal  Hartman               PHONE NO : 888 9639056 
10840 Thornmint Road, Suite 111   SE DECISION MADE: 04-FEB-20
San Diego CA  92127               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pylant Monitor
Kal-Med LLC                       510(k) NO: K191858(Traditional)
ATTN: Sandra  Greenwood           PHONE NO : 585 6334225 
570 Percival Avenue               SE DECISION MADE: 24-FEB-20
Kensington CT  06037              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elos Accurate Customized Abutment
Elos Medtech Pinol A/S            510(k) NO: K191890(Traditional)
ATTN: Tina Friis Poulsen          PHONE NO : 004 548 216469 
Engvej 33                         SE DECISION MADE: 06-FEB-20
Goerloese  DK DK-3330             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Upper Arm Blood Pressure Monitor
ShenZhen ZhengKang Technology Co.,510(k) NO: K191894(Traditional)
ATTN: Huayong  Yang               PHONE NO : 86 755 883260864 
3/F, Building A, No. 3 FuXing Yi LSE DECISION MADE: 21-FEB-20
ShenZhen City  CN 518100          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elos Accurate Hybrid Base
Elos Medtech Pinol A/S            510(k) NO: K191919(Traditional)
ATTN: Tina Friis Poulsen          PHONE NO : 45 4821 6400 
Engvej 33                         SE DECISION MADE: 10-FEB-20
Gorlose  DK DK-3330               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AccuContour
Xiamen Manteia Technology LTD.    510(k) NO: K191928(Traditional)
ATTN: Lu  Xie                     PHONE NO : 86 592 6100813 
1903, B Tower, Zijin Plaza, No.181SE DECISION MADE: 28-FEB-20
Xiamen  CN 361001                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Penumbra System Penumbra JET 7X
Penumbra, Inc.                    510(k) NO: K191946(Traditional)
ATTN: Micaela  Victoria           PHONE NO : 510 9952082 
One Penumbra Place                SE DECISION MADE: 27-FEB-20
Alameda CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NewPrim System
BRM Extremities                   510(k) NO: K191966(Traditional)
ATTN: Andrea  De Maglio           PHONE NO : 389 1938034 
Via Ciro Menotti 10               SE DECISION MADE: 13-FEB-20
Milano MI  20129                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elefix V Paste for EEG & EMG
Nihon Kohden Corporation          510(k) NO: K191975(Traditional)
ATTN: Sandra  Gadeyne             PHONE NO : 949 6809048 
1-31-4 Nishiochiai, Shinjuku-ku   SE DECISION MADE: 07-FEB-20
Tokyo  JP 161-8560                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: D R Burton OxyPAP
D R Burton Healthcare, LLC        510(k) NO: K192000(Traditional)
ATTN: Dennis  Cook                PHONE NO : 252 2287038 
3936 S Fields St                  SE DECISION MADE: 19-FEB-20
Farmville NC  27828               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lucy Point-of-Care Magnetic Resonance Imaging Device
Hyperfine Research, Inc.          510(k) NO: K192002(Traditional)
ATTN: Brian  Sawin                PHONE NO : 
530 Old Whitfield Street          SE DECISION MADE: 06-FEB-20
Guilford CT  06437                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DiaTemp Flow
Diadent Group International       510(k) NO: K192022(Traditional)
ATTN: Kab Sun Lee                 PHONE NO : 82 43 2662315 
16, Osongsaengmyeong 4-ro, Osong-eSE DECISION MADE: 13-FEB-20
Cheongju-si  KR 28161             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tina-quant C-Reactive Protein IV
Roche Diagnostics Operations (RDO)510(k) NO: K192072(Traditional)
ATTN: Barbara Ann McWhorter       PHONE NO : 317 5212336 
9115 Hague Rd                     SE DECISION MADE: 21-FEB-20
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Omnia Medical Trauma Screws
Omnia Medical, LLC                510(k) NO: K192096(Traditional)
ATTN: Troy  Schifano              PHONE NO : 304 4134851 
6 Canyon Rd Suite 300             SE DECISION MADE: 27-FEB-20
Morgantown WV  26508              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Venner PneuX™ ETT (Endotracheal Tube)  6 mm,  Venner PneuX™ ETT (Endotracheal Tube)  7 mm,  Venner PneuX™ ETT (Endotracheal Tube)  8 mm,  Venner PneuX™ ETT (Endotracheal Tube)  9 mm
Venner Medical (Singapore) Pte Ltd510(k) NO: K192120(Traditional)
ATTN: Adrian P Waterton           PHONE NO : 65 6511 2350 
35 Joo Koon Circle                SE DECISION MADE: 14-FEB-20
Singapore  SG 629110              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Respire Pink AT (Hard, Hard/Soft, EF)
Respire Medical Holdings          510(k) NO: K192127(Special)
ATTN: Madubuike  Okafor           PHONE NO : 718 3609209 
18 Bridge St. Suite 3J            SE DECISION MADE: 05-FEB-20
Brooklyn NY  11201                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Maximus System
Hill-Rom Services Pte Ltd         510(k) NO: K192143(Traditional)
ATTN: Alvin  Tan                  PHONE NO : 65 6499 7391 
1 Yishun Ave 7                    SE DECISION MADE: 14-FEB-20
Singapore  SG                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DiaTemp
Diadent Group International       510(k) NO: K192158(Traditional)
ATTN: Kab Sun Lee                 PHONE NO : 82 4326 62315 
16, Osongsaengmyeong 4-ro, Osong-eSE DECISION MADE: 13-FEB-20
Cheongji-si  KR 28161             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Acteon Imaging Suite
de Gotzen S.R.L                   510(k) NO: K192165(Traditional)
ATTN: Dario  Bandiera             PHONE NO : 39 0331 376760 
via Roma, 45                      SE DECISION MADE: 11-FEB-20
Olgiate Olona  IT 21057           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VSP System
3D Systems                        510(k) NO: K192192(Traditional)
ATTN: Kim  Torluemke              PHONE NO : 720 6431001 
5381 South Alkire Circle          SE DECISION MADE: 26-FEB-20
Littleton CO  80127               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JO for Him H2O Gel Original Personal Lubricant
United Consortium                 510(k) NO: K192203(Traditional)
ATTN: Stephanie  Morris           PHONE NO : 661 2951700 
29000 N. Hancock Pkwy.            SE DECISION MADE: 10-FEB-20
Valencia CA  91355                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LED Curing Light
Foshan CICADA Dental Instrument Co510(k) NO: K192233(Traditional)
ATTN: Juan  Liu                   PHONE NO : 86 757 85775667 
B5-2F, Guangdong New Light Source SE DECISION MADE: 13-FEB-20
Foshan  CN                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Steripath Gen2 Blood Collection System
Magnolia Medical Technologies, Inc510(k) NO: K192247(Traditional)
ATTN: Gregory J Bullington        PHONE NO : 1 206 3691319 
200 West Mercer Street Suite 500  SE DECISION MADE: 28-FEB-20
Seattle WA  98119                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SonicEye Dual-Array Ultrasound System
Sonivate Medical Inc              510(k) NO: K192253(Traditional)
ATTN: Steve  Hesler               PHONE NO : 503 2608221 
4640 SW Macadam Ave. Suite 200    SE DECISION MADE: 25-FEB-20
Portland OR  97239                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UCLA CCM Abutment
DIO Corporation                   510(k) NO: K192263(Traditional)
ATTN: Jiae  Park                  PHONE NO : 82 51 7457836 
66, Centum Seo-ro, Haeundae-gu    SE DECISION MADE: 21-FEB-20
Busan  KR 48058                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit
Diadent Group International       510(k) NO: K192273(Traditional)
ATTN: Kab Sun Lee                 PHONE NO : 82 43 2662315 
16, Osongsaengmyeong 4-ro, Osong-eSE DECISION MADE: 07-FEB-20
Cheongu-si  KR 28161              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CardIQ Flow
GE Medical Systems SCS            510(k) NO: K192277(Traditional)
ATTN: Elizabeth  Mathew           PHONE NO : 262 4247774 
283 rue de la Miniere             SE DECISION MADE: 14-FEB-20
Buc  FR 78530                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Colibri Endoscopy System
3NT Medical Ltd.                  510(k) NO: K192305(Special)
ATTN: Ehud  Bendory               PHONE NO : 972 73 7154056 
22 HaMelacha St., POB 11384       SE DECISION MADE: 27-FEB-20
Rosh Ha’Ayin  IL 4809169          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: scaffolene CL100 Bioresorbable Collagen Matrix
Freudenberg Technology Innovation 510(k) NO: K192346(Traditional)
ATTN: Denis  Reibel               PHONE NO : 49 6201 806357 
Hoehnerweg 2-4                    SE DECISION MADE: 28-FEB-20
Weinheim  DE 69469                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ASCEND Image Viewer
Ascend Hit                        510(k) NO: K192372(Traditional)
ATTN: Andy  Miller                PHONE NO : 1 224 7650885 
801 Warrenville Road Ste 200      SE DECISION MADE: 14-FEB-20
Lisle IL  60532                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon
Varian Medical Systems, Inc.      510(k) NO: K192377(Traditional)
ATTN: Peter J Coronado            PHONE NO : 650 4246320 
911 Hansen Way                    SE DECISION MADE: 10-FEB-20
Palo Alto CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor
Scientifica Pharmaceuticals       510(k) NO: K192381(Traditional)
ATTN: Thomas  Kelly               PHONE NO : 909 5959922 
3221 Producer Way                 SE DECISION MADE: 18-FEB-20
Pmona CA  91768                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Praxiject 0.9% NaCl
MedXL Inc.                        510(k) NO: K192414(Special)
ATTN: Premala  Premanathan        PHONE NO : 1 514 6957474 
285 Av Labrosse                   SE DECISION MADE: 13-FEB-20
Pointe-Claire  CA H9R 1A3         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Superelastic Staple
Neosteo                           510(k) NO: K192447(Traditional)
ATTN: Anne-Cecile  Grandremy      PHONE NO : 33 23656 9670 
Malleve 2A, 1 Boulevard Jean MouliSE DECISION MADE: 28-FEB-20
Nantes  FR 44 100                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sentinel Cerebral Protection System
Boston Scientific Corporation     510(k) NO: K192460(Special)
ATTN: Eric  Elliott               PHONE NO : 763 4942081 
Three Scimed Place                SE DECISION MADE: 19-FEB-20
Maple Grove MN  55311-1566        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Coolief Radiofrequency Generator (CRG) System
Avanos Medical, Inc.              510(k) NO: K192491(Traditional)
ATTN: Thomas  Kozma               PHONE NO : 844 4282667 
5405 Windward Parkway, Suite 100  SE DECISION MADE: 21-FEB-20
Alpharetta GA  30004              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Magnetom Sola, Magnetom Altea and Magnetom Sola Fit
Siemens Medical Solutions USA Inc.510(k) NO: K192496(Traditional)
ATTN: Cordell L Fields            PHONE NO : 610 4486469 
40 Liberty Boulevard, Mail Code 65SE DECISION MADE: 28-FEB-20
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rochal Antimicrobial Wound Gel
Rochal Industries, LLC            510(k) NO: K192527(Traditional)
ATTN: William J. Coulston         PHONE NO : 210 3759349 
12000 Network Blvd, Ste B200      SE DECISION MADE: 07-FEB-20
San Antonio TX  78249             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Potenza
Jeisys Medical Incorporated       510(k) NO: K192545(Traditional)
ATTN: Wonchel  Choi               PHONE NO : 82 707435 4626 
307 Daeyung Techno Town 8th; GamasSE DECISION MADE: 20-FEB-20
Seoul  KR 08501                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Youjia Unscented Tampon with Plastic Applicators
Qingdao Youjia Hygiene Technology 510(k) NO: K192557(Special)
ATTN: Huiying  Zhao               PHONE NO : 86 532 86613616 
No. 778 Mingyue Road, Huangdao ZonSE DECISION MADE: 13-FEB-20
Qingdao  CN 266400                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Atlas Spine Expandable Cervical Standalone Interbody System
Atlas Spine, Inc.                 510(k) NO: K192570(Traditional)
ATTN: Thomas  Smith               PHONE NO : 561 7411108 
1555 Jupiter Park Drive, Suite 1  SE DECISION MADE: 28-FEB-20
Jupiter FL  33458                 510(k) STATEMENT
                                                    

DEVICE: X-Guide Surgical Navigation System
X-Nav Technologies, LLC           510(k) NO: K192579(Traditional)
ATTN: Fred  Cowdery               PHONE NO : 267 4360414 
1555 Bustard Road, Suite 75       SE DECISION MADE: 03-FEB-20
Lansdale PA  19446                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ULab Systems Dental Aligner Kit
uLab Systems, Inc.                510(k) NO: K192596(Traditional)
ATTN: Charlie  Wen                PHONE NO : 650 8041397 
6 Lagoon Drive, Suite 180         SE DECISION MADE: 11-FEB-20
Redwood City CA  94065            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60
quanta system spa                 510(k) NO: K192600(Special)
ATTN: Francesco  Dell'Antonio     PHONE NO : 39 0331 376797 
via Acquedotto 109                SE DECISION MADE: 21-FEB-20
Samarate (Va)  IT 21017           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment
MegaGen Implant CO., Ltd.         510(k) NO: K192614(Traditional)
ATTN: You Jung Kim                PHONE NO : 82 53 2222991 
45, Secheon-ro, 7-gil, Dasa-eup, DSE DECISION MADE: 13-FEB-20
Daegu  KR 42921                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gemini 810+980 Soft Tissue Laser
Azena Medical, LLC                510(k) NO: K192617(Traditional)
ATTN: Lindsay  Tilton             PHONE NO : 800 4665273 
3021 Citrus Circle Ste 180        SE DECISION MADE: 20-FEB-20
Walnut Creek CA  94598            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pitkar Locked Plating System
S H Pitkar Orthotools Pvt Ltd.    510(k) NO: K192619(Traditional)
ATTN: Vivek  Mangalwedhekar       PHONE NO : 91 204 0706464 
Plot No. EL 32, J Block, MIDC BhosSE DECISION MADE: 27-FEB-20
Pune  IN 411026                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ApneaTrak
Cadwell Industries, Inc.          510(k) NO: K192624(Traditional)
ATTN: James  Blevins              PHONE NO : 509 7356481 
909 N. Kellogg Street             SE DECISION MADE: 20-FEB-20
Kennewick WA  99336               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zimmer M/L Taper Hip Prosthesis
Zimmer, Inc.                      510(k) NO: K192660(Traditional)
ATTN: Caleb  Barylski             PHONE NO : 574 3710250 
1800 W. Center Street             SE DECISION MADE: 28-FEB-20
Warsaw IN  46580                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CapsoCam Plus (SV-3) Capsule Endoscopy System
CapsoVision, Inc.                 510(k) NO: K192662(Traditional)
ATTN: Azimun  Jamal               PHONE NO : 408 6241488 
18805 Cox Avenue Suite 250        SE DECISION MADE: 14-FEB-20
Saratoga CA  95070                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mixing and Delivery System
Bone Solutions, Inc.              510(k) NO: K192674(Traditional)
ATTN: Drew  Diaz                  PHONE NO : 817 8098850 
5712 Colleyville Blvd, STE 210    SE DECISION MADE: 18-FEB-20
Colleyville TX  76034             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Safety Insulin Pen Needle
Jiangsu Caina Medical Co., Ltd.   510(k) NO: K192677(Traditional)
ATTN: Jianwei  Pan                PHONE NO : 86 510 86866666 8027
No.3, Huanxi Road, Zhutang Town   SE DECISION MADE: 18-FEB-20
Jiangyin  CN 214415               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads
Biomet UK Ltd.                    510(k) NO: K192683(Traditional)
ATTN: Lisa  Ingram                PHONE NO : 44 1656 655221 
Waterton Industrial Estate        SE DECISION MADE: 27-FEB-20
Bridgend  GB CF31 3XA             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: s-Clean SQ-SL Implant System Regular
Dentis Co., Ltd.                  510(k) NO: K192688(Traditional)
ATTN: Gyu Ri Kim                  PHONE NO : 82 53 5893541 
99, Seongseoseo-ro, Dalseo-gu     SE DECISION MADE: 04-FEB-20
Daegu  KR 42718                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PatCom Single-Use Introducer
H&A Mui Enterprises Inc.          510(k) NO: K192691(Traditional)
ATTN: Tammy  Mui                  PHONE NO : 905 890 5525 
145 Traders Blvd. E., Unit #34    SE DECISION MADE: 21-FEB-20
Mississauga  CA L4Z 3L3           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dermadry
Dermadry Laboratories inc.        510(k) NO: K192749(Traditional)
ATTN: Maxime  Calouche            PHONE NO : 1 514 9039897 
9223 Langelier Blvd               SE DECISION MADE: 10-FEB-20
Montreal  CA H1P 3K9              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aquadex FlexFlow System 2.0
CHF Solutions, Inc.               510(k) NO: K192756(Traditional)
ATTN: Dawn  Li                    PHONE NO : 952 5636278 
12988 Valley View Road            SE DECISION MADE: 24-FEB-20
Eden Prairie MN  55344            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20
VitalConnect, Inc.                510(k) NO: K192757(Traditional)
ATTN: Cynthia  Merrell            PHONE NO : 1 408 9634600 
224 Airport Parkway, Suite 300    SE DECISION MADE: 06-FEB-20
San Jose CA  95110                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OptiScanner® 5000 Glucose Monitoring System
Optiscan Biomedical Corporation   510(k) NO: K192785(Traditional)
ATTN: Charles  Zimliki            PHONE NO : 240 3506690 
24590 Clawiter Road               SE DECISION MADE: 05-FEB-20
Hayward CA  94545                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Glenoid Baseplate with Screw
FX Shoulder USA, Inc.             510(k) NO: K192799(Traditional)
ATTN: Kathy  Trier                PHONE NO : 800 2800775 
13465 Midway Road, Suite 101      SE DECISION MADE: 21-FEB-20
Dallas TX  75244                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm
Medos International SARL          510(k) NO: K192804(Traditional)
ATTN: Michael  Liao               PHONE NO : 510 7705376 
Chemin-Blanc 38                   SE DECISION MADE: 27-FEB-20
Le Locle Neuchatel  CH 2400       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DENTCA Crown and Bridge
Dentca, Inc.                      510(k) NO: K192806(Traditional)
ATTN: Jason  Lee                  PHONE NO : 424 5588726 
357 Van Ness Way #250             SE DECISION MADE: 05-FEB-20
Torrance CA  90501                510(k) STATEMENT
                                                    

DEVICE: SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs)
Medline Industries, Inc.          510(k) NO: K192820(Traditional)
ATTN: Matt  Clausen               PHONE NO : 847 6434785 
Three Lakes Drive                 SE DECISION MADE: 28-FEB-20
Northfield IL  60093              510(k) STATEMENT
                                                    

DEVICE: Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System
Canon Medical Systems Corporation 510(k) NO: K192828(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 13-FEB-20
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i
Canon Medical Systems Corporation 510(k) NO: K192832(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 21-FEB-20
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InPen System
Companion Medical, Inc.           510(k) NO: K192841(Traditional)
ATTN: Jasper  Benke               PHONE NO : 858 5220252 
11011 Via Frontera, Suite D       SE DECISION MADE: 10-FEB-20
San Diego CA  92127               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Argen Clear Aligner, Argen Clear Aligner Premium
Argen Corporation                 510(k) NO: K192846(Special)
ATTN: Paul  Cascone               PHONE NO : 858 6268612 
5855 Oberlin Drive                SE DECISION MADE: 10-FEB-20
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OASIS MRI System
Hitachi Healthcare Americas       510(k) NO: K192851(Traditional)
ATTN: Aaron  Pierce               PHONE NO : 330 4251313 
1959 Summit Commerce Park         SE DECISION MADE: 21-FEB-20
Twinsburg OH  44087               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DELTA XTEND(TM) Reverse Shoulder System
DePuy (Ireland)                   510(k) NO: K192855(Traditional)
ATTN: Ashley  Goncalo             PHONE NO : 508 9773907 
Loughbeg Ringaskiddy              SE DECISION MADE: 24-FEB-20
County Cork  IE                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INTELLIO Tablet Application
Smith & Nephew                    510(k) NO: K192876(Traditional)
ATTN: Janice  Haselton            PHONE NO : 978 7491494 
150 Minuteman Rd                  SE DECISION MADE: 27-FEB-20
Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vita Flex CR System with LLI
Carestream Health, Inc.           510(k) NO: K192894(Special)
ATTN: Duane  Gutowski             PHONE NO : 585 6278760 
150 Verona Street                 SE DECISION MADE: 18-FEB-20
Rochester NY  14608               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PneumoLiner
Advanced Surgical Concepts        510(k) NO: K192898(Traditional)
ATTN: Edward  Hyland              PHONE NO : 353 1 2864777 
Unit 4, Sunnybank Center, Upper DaSE DECISION MADE: 25-FEB-20
Bray  IE A98 E339                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Video Laparoscope, Video Processor, Light Source
FUJIFILM Corporation              510(k) NO: K192918(Traditional)
ATTN: Randy  Vader                PHONE NO : 360  3566821 
798 Miyanodai Kaisei-Machi        SE DECISION MADE: 20-FEB-20
Ashigarakami-Gun  JP 2588538      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter
Gentuity, LLC                     510(k) NO: K192922(Traditional)
ATTN: David  Kolstad              PHONE NO : 978 2024108 203
142 North Road, Suite G           SE DECISION MADE: 20-FEB-20
Sudbury MA  01776                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vitrea Software Package
Canon Medical Systems Corporation 510(k) NO: K192923(Traditional)
ATTN: Paul  Biggins               PHONE NO : 81 287 266478 
1385 Shimoishigami                SE DECISION MADE: 14-FEB-20
Otawara  JP 324-8550              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: icobrain-ctp
Icometrix NV                      510(k) NO: K192962(Traditional)
ATTN: Dirk  Smeets                PHONE NO : 32 1636 9000 
Kolonel Begaultlaan 1b/12         SE DECISION MADE: 28-FEB-20
Leuven  BE 3012                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: densitas densityai
Densitas, Inc.                    510(k) NO: K192973(Special)
ATTN: Mo  Abdolell                PHONE NO : 1 902 4025505 
#66, 1344 Summer Street           SE DECISION MADE: 19-FEB-20
Halifax  CA B3H0A8                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: speX Support Catheter
ReFlow Medical                    510(k) NO: K193012(Traditional)
ATTN: Krystal  Santiago           PHONE NO : 310 7075882 
208 Avenida Fabricante #100       SE DECISION MADE: 19-FEB-20
San Clemente CA  92672            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AcQMap High Resolution Imaging and Mapping System
Acutus Medical, Inc.              510(k) NO: K193013(Traditional)
ATTN: Karla  Schaffner            PHONE NO : 1 442 2326161 
2210 Faraday Ave., Suite 100      SE DECISION MADE: 11-FEB-20
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HydroPICC (PICC-142)
Access Vascular, Inc              510(k) NO: K193015(Traditional)
ATTN: Brian  Hanley               PHONE NO : 781 5386594 101
175 Middlesex Turnpike Suite 1A   SE DECISION MADE: 20-FEB-20
Bedford MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CONQUEST FN
Smith & Nephew, Inc.              510(k) NO: K193029(Traditional)
ATTN: Thomas  Fearnley            PHONE NO : 901 3991224 
1450 E Brooks Rd                  SE DECISION MADE: 28-FEB-20
Memphis TN  38116                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Exactech® Equinoxe® Reverse Shoulder Glenospheres
Exactech, Inc                     510(k) NO: K193098(Special)
ATTN: Zach  Sharrah               PHONE NO : 352 3771140 
2320 NW 66th Court                SE DECISION MADE: 20-FEB-20
Gainesville FL  32653             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeoBase 2 Non-derivatized MSMS Kit
PerkinElmer Inc.                  510(k) NO: K193103(Traditional)
ATTN: Eva  Nalian                 PHONE NO : 1 647 6338435 
940 Winter Street                 SE DECISION MADE: 07-FEB-20
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TGS Guidewire and updated Scopis Software
Stryker ENT                       510(k) NO: K193118(Traditional)
ATTN: Bruce  Backlund             PHONE NO : 763 7625902 
3600 Holly Lane North, Suite 40   SE DECISION MADE: 21-FEB-20
Plymouth MN  55447                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Real Intelligence Cori
Blue Belt Technologies, Inc.      510(k) NO: K193120(Traditional)
ATTN: Corrine  Herlinger          PHONE NO : 763 4524950 
2905 Northwest Blvd. Ste. 40      SE DECISION MADE: 14-FEB-20
Plymouth MN  55441                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mako Total Hip Application
Mako Surgical Corp.               510(k) NO: K193128(Traditional)
ATTN: Liza  Gordillo              PHONE NO : 954 6280802 
2555 Davie Rd                     SE DECISION MADE: 02-FEB-20
Fort Lauderdale FL  33317         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Yukon OCT Spinal System
K2M, Inc.                         510(k) NO: K193129(Traditional)
ATTN: Oonagh  Lahiff              PHONE NO : 
600 Hope Parkway SE               SE DECISION MADE: 07-FEB-20
Leesburg VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Affinity
Hermes Medical Solutions AB       510(k) NO: K193152(Traditional)
ATTN: Joakim  Arwidson            PHONE NO : 468 190325 
Strandbergsgatan 16               SE DECISION MADE: 14-FEB-20
Stockholm  SE 11251               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M Attest Super Rapid 5 Steam-Plus Challenge Pack
3M Company                        510(k) NO: K193154(Traditional)
ATTN: Mary  Fretland              PHONE NO : 651 7372296 
Bldg. 275-5W-06                   SE DECISION MADE: 07-FEB-20
St. Paul MS  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex Mini Comprehensive Fixation System - 1.0mm Screws
Arthrex Inc.                      510(k) NO: K193156(Traditional)
ATTN: Rebecca R. Homan            PHONE NO : 1 239 6435553 73429
1370 Creekside Boulevard          SE DECISION MADE: 10-FEB-20
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MectaFix CL Fixation Button with Continuous Loop
Medacta International SA          510(k) NO: K193165(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91696 6060 
Strada Regina                     SE DECISION MADE: 10-FEB-20
Castel San Pietro  CH cH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Agilon Moldable
Biogennix, LLC.                   510(k) NO: K193168(Traditional)
ATTN: Timothy  Bumbalough         PHONE NO : 949 2530994 
1641 McGaw Ave                    SE DECISION MADE: 13-FEB-20
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biograph Horizon
Siemens Medical Solution USA, Inc.510(k) NO: K193178(Traditional)
ATTN: Alaine  Medio               PHONE NO : 865 2060337 
810 Innovation Drive              SE DECISION MADE: 12-FEB-20
Knoxville TN  37932               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alliance Augmented Glenoid
Zimmer Inc.                       510(k) NO: K193180(Traditional)
ATTN: Patricia Sandborn Beres     PHONE NO : 574 2676639 
P.O. Box 708                      SE DECISION MADE: 24-FEB-20
Warsaw IN  46581-0708             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MOJAVE Expandable Interbody System
K2M, Inc.                         510(k) NO: K193203(Special)
ATTN: Oonagh  Lahiff              PHONE NO : 
600 Hope Parkway SE               SE DECISION MADE: 18-FEB-20
Leesburg VA  21075                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wego-Stainless Steel
Foosin Medical Supplies Inc., Ltd.510(k) NO: K193209(Traditional)
ATTN: Zhipeng  Yang               PHONE NO : 86 631 5660576 
No.20, Xingshan Road, Weihai TorchSE DECISION MADE: 19-FEB-20
Weihai  CN 264210                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Daytona® Small Stature Growth Rod Conversion Set
SeaSpine Orthopedics Corporation  510(k) NO: K193224(Traditional)
ATTN: Jesse  Albright             PHONE NO : 760 2165176 
5770 Armada Drive                 SE DECISION MADE: 13-FEB-20
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology
Covidien LLC                      510(k) NO: K193232(Special)
ATTN: Hilla  Debby                PHONE NO : 972 4 9097774 
6135 Gunbarrel Ave                SE DECISION MADE: 13-FEB-20
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories
Masimo Corporation                510(k) NO: K193242(Traditional)
ATTN: Sindura  Penubarthi         PHONE NO : 949 2977592 
52 Discovery                      SE DECISION MADE: 27-FEB-20
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alta Multipurpose Device
Qfix                              510(k) NO: K193243(Traditional)
ATTN: Alexandra Low Smythe        PHONE NO : 610 2680585 
440 Church Road                   SE DECISION MADE: 28-FEB-20
Avondale PA  19311                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dunamis PunchTac Suture Anchors
Dunamis LLC                       510(k) NO: K193245(Special)
ATTN: Prithviraj  Chavan          PHONE NO : 877 4542186 
509 E. Commerce Street Suite 3    SE DECISION MADE: 14-FEB-20
Greenville AL  36037              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biograph Vision, Biograph mCT Family of PET/CTs
Siemens Medical Solutions USA, Inc510(k) NO: K193248(Traditional)
ATTN: Tabitha  Estes              PHONE NO : 865 8044553 
810 Innovation Drive              SE DECISION MADE: 14-FEB-20
Knoxville TN  37932               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Largo PEEK Interbody System
FloSpine, LLC                     510(k) NO: K193255(Traditional)
ATTN: Peter  Harris               PHONE NO : 561 7053080 
3651 Fau Boulevard, Suite 400     SE DECISION MADE: 20-FEB-20
Boca Raton FL  33431              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: APrioCore Plus
AprioMed AB                       510(k) NO: K193268(Traditional)
ATTN: Katrin  Svensson            PHONE NO : 46 18 4301440 
Virdings Alle 28                  SE DECISION MADE: 27-FEB-20
Uppsala  SE 75450                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rodo Abutment System
RODO Medical, Inc.                510(k) NO: K193274(Traditional)
ATTN: James  Park                 PHONE NO : 1 408 2457636 
6399 San Ignacio Ave., Suite 100  SE DECISION MADE: 27-FEB-20
San Jose CA  95119                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tinnitus Sound Generator Module
GN Hearing A/S                    510(k) NO: K193303(Special)
ATTN: Lars  Hagander              PHONE NO : 45 45 751111 
Lautrupbjerg 7                    SE DECISION MADE: 20-FEB-20
Ballerup  DK 2750                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: T2 Alpha Tibia Nailing System, IMN Screws System
Stryker Trauma GmbH               510(k) NO: K193308(Traditional)
ATTN: Sanja  Jahr                 PHONE NO : 201 8316797 
325 Corporate Drive               SE DECISION MADE: 23-FEB-20
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elecsys Anti-TSHR
Roche Diagnostics                 510(k) NO: K193313(Traditional)
ATTN: Reanna  Toney               PHONE NO : 317 5214516 
9115 Hague Road                   SE DECISION MADE: 27-FEB-20
Indianapolis IN  46256            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System
Kyocera Medical Technologies, Inc.510(k) NO: K193320(Traditional)
ATTN: Anthony  DeBenedictis       PHONE NO : 909 5572360 
1200 California St, Suite 210     SE DECISION MADE: 04-FEB-20
Redlands CA  92374                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Motion Correction System
KinetiCor, Inc.                   510(k) NO: K193324(Traditional)
ATTN: Doug  Donzelli              PHONE NO : 808 3801444 
3465 Waialae Avenue, Suite 300A   SE DECISION MADE: 04-FEB-20
Honolulu HI  96816                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PERLA® TL posterior osteosynthesis system
Spineart                          510(k) NO: K193396(Traditional)
ATTN: Franck  Pennesi             PHONE NO : 41 22 5701200 
3 chemin du pre Fleuri            SE DECISION MADE: 05-FEB-20
Plan Les Ouates  CH 1228          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Summit DuoFix HA Coating
DePuy Orthopaedics, Inc.          510(k) NO: K193398(Special)
ATTN: Erin  Combs                 PHONE NO : 574 3727211 
700 Orthopaedic Drive             SE DECISION MADE: 04-FEB-20
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NEXXT MATRIXX System
Nexxt Spine LLC                   510(k) NO: K193412(Traditional)
ATTN: Andy  Elsbury               PHONE NO : 317 4367801 
14425 Bergen Blvd, Suite B        SE DECISION MADE: 24-FEB-20
Noblesville IN  46060             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trigon HA Stand-Alone Wedge Fixation System
Nvision Biomedical Technologies, I510(k) NO: K193414(Traditional)
ATTN: Diana  Langham              PHONE NO : 210 5453713 
4754 Shavano Oak, Suite 101       SE DECISION MADE: 25-FEB-20
San Antonio TX  78249             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cellvizio I.V.E. with Confocal Miniprobes
Mauna Kea Technologies            510(k) NO: K193416(Traditional)
ATTN: Veronique  Dentan           PHONE NO : 33 170 080994 
9 Rue d'Enghien                   SE DECISION MADE: 28-FEB-20
Paris  FR 75010                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Titanium Interference Screws
Biomet Inc.                       510(k) NO: K193451(Traditional)
ATTN: Saveetha  Raghupathi        PHONE NO : 877 6520830 236
56 East Bell Drive, PO Box 587    SE DECISION MADE: 24-FEB-20
Warsaw IN  46581                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MectaLock All-Suture Anchors
Medacta International SA          510(k) NO: K193461(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 06-FEB-20
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Swan-Ganz Catheters
Edwards Lifesciences, LLC         510(k) NO: K193466(Traditional)
ATTN: Anne  Lo                    PHONE NO : 949 2503386 
One Edwards Way                   SE DECISION MADE: 16-FEB-20
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OrthoCircle Spine Pedicle Screw System
OrthoCircle Spine                 510(k) NO: K193472(Traditional)
ATTN: Jack  Mathews               PHONE NO : 888 4635803 
15 East Montgomery Crossroads. SuiSE DECISION MADE: 13-FEB-20
Savannah GA  31406                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OneTouch Verio Reflect Blood Glucose Monitoring System
LifeScan Europe GmbH              510(k) NO: K193475(Traditional)
ATTN: Niki  Skelly                PHONE NO : 44 0 1463383735 
Gubelstrasse 34                   SE DECISION MADE: 14-FEB-20
Zug  CH CH-6300                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Basal-IQ Technology
Tandem Diabetes Care, Inc.        510(k) NO: K193483(Traditional)
ATTN: Trevor J Dendo              PHONE NO : 858 2246136 
11075 Roselle Street              SE DECISION MADE: 28-FEB-20
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADVIA Centaur BR
Siemens Healthcare Diagnostics Inc510(k) NO: K193489(Traditional)
ATTN: Ian  Thompson               PHONE NO : 914 5242296 
511 Benedict Avenue               SE DECISION MADE: 13-FEB-20
Tarrytown NY  10591               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infinitt RT PACS
Infinitt Healthcare Co.,Ltd.      510(k) NO: K193498(Traditional)
ATTN: Sang Wook  Cho              PHONE NO : 82 22192 1631 
12F Daerung Post Tower III, 27 DigSE DECISION MADE: 13-FEB-20
Seoul  KR 08378                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TGS Universal Headrest with Mounting Arm
Stryker ENT                       510(k) NO: K193502(Traditional)
ATTN: Denise  Thompson            PHONE NO : 269 8880219 
3600 Holly Lane North, Suite 40   SE DECISION MADE: 14-FEB-20
Plymouth MN  55447                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System
NuVasive Incorporated             510(k) NO: K193506(Special)
ATTN: Aditya  Sharma              PHONE NO : 858 4800263 
7475 Lusk Boulevard               SE DECISION MADE: 26-FEB-20
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Steerable Plateau Ti
Life Spine, Inc.                  510(k) NO: K193521(Traditional)
ATTN: Angela  Batker              PHONE NO : 847 8846117 
13951 S Quality Drive             SE DECISION MADE: 06-FEB-20
Huntley IL  60142                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WIN Flexible Nail System
Biomet Inc.                       510(k) NO: K193533(Traditional)
ATTN: Dominique  Dompor           PHONE NO : 877 6520830 169
56 East Bell Drive, PO Box 587    SE DECISION MADE: 20-FEB-20
Warsaw IN  46581                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Therm-X
Zenith Technical Innovations      510(k) NO: K193550(Traditional)
ATTN: Greg  Binversie             PHONE NO : 847 6727481 
1396 St. Paul Ave.                SE DECISION MADE: 28-FEB-20
Gurnee IL  60031                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System
Medartis AG                       510(k) NO: K193554(Traditional)
ATTN: Andrea  Kiefer-Schweizer    PHONE NO : 41 61 6333434 
Hochbergerstrasse 60E             SE DECISION MADE: 16-FEB-20
Basel  CH CH-4057                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL)
BioMerieux, Inc.                  510(k) NO: K193567(Traditional)
ATTN: Esther  Hernandez           PHONE NO : 314 7318841 
595 Anglum Road                   SE DECISION MADE: 14-FEB-20
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sutter Swyng non-stick bipolar forceps, single-use
Sutter Medizintechnik GmbH        510(k) NO: K193587(Traditional)
ATTN: Ulrike  Zeissler            PHONE NO : 490 761 5155114 
Tullastrasse 87                   SE DECISION MADE: 10-FEB-20
Freiburg  DE 79108                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wingman 14, Wingman 14C, Wingman 18, Wingman 35
Reflow Medical                    510(k) NO: K193596(Traditional)
ATTN: Krystal  Santiago           PHONE NO : 310 7075882 
208 Avenida Fabricante #100       SE DECISION MADE: 20-FEB-20
San Clemente CA  92672            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BreathID Smart System
Exalenz Bioscience Ltd.           510(k) NO: K193610(Special)
ATTN: Raffi  Werner               PHONE NO : 011 97289 737502 
4 Ha'Maayan st.                   SE DECISION MADE: 06-FEB-20
Modiin  IL 7177872                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: E-COM DR-2000 DR
LiverMoreTech, Inc.               510(k) NO: K193644(Traditional)
ATTN: Jay  Kim                    PHONE NO : 214 2570113 
801 North Jupiter Rd, Suite 200,  SE DECISION MADE: 14-FEB-20
Plano TX  75074                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: uCT 530, uCT 550
Shanghai United Imaging Healthcare510(k) NO: K200016(Traditional)
ATTN: Xin  Gao                    PHONE NO : 86 21 67076888 5386
No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 25-FEB-20
Shanghai  CN 201807               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Optima Coil System
Balt USA, LLC                     510(k) NO: K200030(Special)
ATTN: Michael  Peters             PHONE NO : 949 7881443 
29 Parker                         SE DECISION MADE: 01-FEB-20
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endosee System
CooperSurgical, Inc.              510(k) NO: K200038(Special)
ATTN: Christine  Kupchick         PHONE NO : 203 6015200 
95 Corporate Drive                SE DECISION MADE: 05-FEB-20
Trumbull CT  06611                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Akesis Galaxy RTx
Akesis Inc                        510(k) NO: K200050(Special)
ATTN: Christopher  Brown          PHONE NO : 1 925 4081381 
5129 Commercial Circle            SE DECISION MADE: 04-FEB-20
Concord CA  94520                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System
Roche Molecular Systems, Inc.     510(k) NO: K200065(Special)
ATTN: Kaitlyn  Hameister          PHONE NO : 925 7308813 
4300 Hacienda Drive               SE DECISION MADE: 10-FEB-20
Pleasanton CA  94588-2722         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearPoint System and Accessories
MRI Interventions, Inc            510(k) NO: K200079(Special)
ATTN: Pete  Piferi                PHONE NO : 949 9006833 
5 Musick                          SE DECISION MADE: 13-FEB-20
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EMBA Hourglass Peripheral Embolization Device (PED)
Embolic Acceleration, LLC         510(k) NO: K200083(Special)
ATTN: Veronica  McDougall         PHONE NO : 954 8741016 
3451 Commerce Pkwy                SE DECISION MADE: 14-FEB-20
Miramar FL  33025                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trevo NXT ProVue Retriever
Stryker                           510(k) NO: K200117(Special)
ATTN: Germaine  Fu                PHONE NO : 510 4132862 
47900 Bayside Parkway             SE DECISION MADE: 07-FEB-20
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: M.U.S.T. MINI Posterior Cervical Screws System
Medacta International SA          510(k) NO: K200130(Special)
ATTN: Stefano  Baj                PHONE NO : 41 91696 6060 
Strada Regina                     SE DECISION MADE: 10-FEB-20
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ashvins
MedicalCommunications GmbH        510(k) NO: K200132(Traditional)
ATTN: Martin  Schinkmann          PHONE NO : 49 6221 75310 
Max-Jarecki-Strasse 8             SE DECISION MADE: 18-FEB-20
Heidelberg  DE 69115              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LightForce Orthodontic System (LFO System)
LightForce Orthodontics           510(k) NO: K200148(Third Party - Traditional)
ATTN: Amos N Benninga             PHONE NO : 800 4810185 
1035 Cambridge Street, Suite 14a  SE DECISION MADE: 21-FEB-20
Cambridge MA  02141               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: 3MP Monochrome Digital Mammography LCD Monitor MS-S300
Jvckenwood Corporation            510(k) NO: K200161(Traditional)
ATTN: Hideki  Tengeiji            PHONE NO : 81 45450 2715 
3-12, Moriya-cho, Kanagawa-ku     SE DECISION MADE: 21-FEB-20
Yokohama  JP 221-0022             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SpineNet SSP System
SpineNet LLC                      510(k) NO: K200170(Traditional)
ATTN: King  Floyd                 PHONE NO : 407 5392483 
1300 Minnesota Ave., Suite 200    SE DECISION MADE: 05-FEB-20
Winter Park FL  32789             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ez3D-i /E3
Ewoosoft Co., Ltd.                510(k) NO: K200178(Special)
ATTN: Young Seok Kim              PHONE NO : 82 31 80156172 
801-ho, Vatechnetworks Bldg., 13, SE DECISION MADE: 25-FEB-20
Hwaseong-si  KR 18449             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Collaboration Live
Philips Healthcare                510(k) NO: K200179(Third Party - Traditional)
ATTN: Paul  Elias                 PHONE NO : 425 4828396 
22100 Bothell Everett Highway     SE DECISION MADE: 18-FEB-20
Bothell WA  98021-8431            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: EzRay Air Portable (Model: VEX-P300)
Vatech Co., Ltd                   510(k) NO: K200182(Special)
ATTN: Daniel  Kim                 PHONE NO : 82 31 3799492 
13, Samsung 1-ro 2-gil            SE DECISION MADE: 11-FEB-20
Hwaseong-si  KR 18449             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SmoothSkin Pure
CyDen Limited                     510(k) NO: K200184(Special)
ATTN: Adam  Stephens              PHONE NO : 440 1792 274009 
Block A, Bay Studios Business ParkSE DECISION MADE: 21-FEB-20
Swansea  GB SA1 8QB               510(k) STATEMENT
                                                    

DEVICE: Luna Dental Implant System- Healing Abutment
Shinhung MST Co., Ltd.            510(k) NO: K200189(Special)
ATTN: Jae Soo Song                PHONE NO : 82 33730 1901 
110-2, Donghwagong-Ro Munmak-Eup  SE DECISION MADE: 26-FEB-20
Wonju Si  KR 220-801              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARK™ Fentanyl II Assay
ARK Diagnostics, Inc.             510(k) NO: K200197(Traditional)
ATTN: Thomas  Houts               PHONE NO : 510 2706296 
48089 Fremont Boulevard           SE DECISION MADE: 26-FEB-20
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter
Stryker Neurovascular             510(k) NO: K200206(Special)
ATTN: Shazia  Hakim               PHONE NO : 510 4132636 
47900 Bayside Parkway             SE DECISION MADE: 27-FEB-20
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3D Predict
3D Smile USA, Inc                 510(k) NO: K200214(Third Party - Traditional)
ATTN: Marina  Domracheva          PHONE NO : 
3675 Market Street Suite #200     SE DECISION MADE: 24-FEB-20
Philadelphia PA  19104            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor
Mick Radio-Nuclear Instruments, In510(k) NO: K200221(Special)
ATTN: James  Hurlman              PHONE NO : 914 6673999 
521 Homestead Avenue              SE DECISION MADE: 28-FEB-20
Mount Vernon NY  10550            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arctic Sun Stat Temperature Management System
Medivance, Inc.                   510(k) NO: K200225(Special)
ATTN: Jacquelyn  Borinski         PHONE NO : 720 8805343 
321 South Taylor Ave, Suite 200   SE DECISION MADE: 28-FEB-20
Louisville CO  80027              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearCam System
ClearCam, LLC                     510(k) NO: K200228(Third Party - Traditional)
ATTN: Chris  Idelson              PHONE NO : 410 8972858 
1601 Trinity St., Bldg B M/S Z-140SE DECISION MADE: 19-FEB-20
Austin TX  78712                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Surgical laser fibers
Quanta System Spa                 510(k) NO: K200234(Special)
ATTN: Francesco  Dell’Antonio     PHONE NO : 39 0331 376797 
Via Acquedotto 109                SE DECISION MADE: 25-FEB-20
Samarate (Va)  IT 21017           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITROS BRAHMS PCT Reagent Pack and Calibrators
Ortho Clinical Diagnostics        510(k) NO: K200236(Traditional)
ATTN: Ann M Quinn                 PHONE NO : 585 4534152 
100 Indigo Creek Drive            SE DECISION MADE: 25-FEB-20
Rochester NY  14626               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fusion Quattro Extraction Balloon
Wilson-Cook Medical, Inc          510(k) NO: K200247(Special)
ATTN: Tiffanny A Thomas           PHONE NO : 336 7440157 396518
4900 Bethania Station Road        SE DECISION MADE: 27-FEB-20
Winston-Salem NC  27105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: R-Sensor, R-Sensor
Remedi Co. Ltd.                   510(k) NO: K200284(Traditional)
ATTN: Jadon  Koo                  PHONE NO : 82 2 69682041 
#1409, IS BIZ Tower, 26 YangpyeongSE DECISION MADE: 28-FEB-20
Seoul  KR                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Daytona® Small Stature Spinal System
SeaSpine Orthopedics Corporation  510(k) NO: K200381(Special)
ATTN: Alicia  McArthur            PHONE NO : 760 2165117 
5770 Armada Drive                 SE DECISION MADE: 28-FEB-20
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    


           TOTAL 510(k)s THIS PERIOD   224                                     
           TOTAL WITH SUMMARIES        215                                     
           TOTAL WITH STATEMENTS         9