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  1. 510(k) Clearances

November 2019 510(K) Clearances

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


DEVICE: Revitalair 430F
Oxavita S.R.L.                    510(k) NO: K171899(Traditional)
ATTN: Eduardo  Northing           PHONE NO : 54 11 45731511 
Tamborini 5813                    SE DECISION MADE: 22-NOV-19
Buenos Aires  AR                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray
OraLabs, Inc.                     510(k) NO: K181839(Traditional)
ATTN: Gary  Schlatter             PHONE NO : 303 2613203 
18685 East Plaza Drive            SE DECISION MADE: 21-NOV-19
Parker CO  80134                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pivot System Sterilization case
RP Medical, Inc.                  510(k) NO: K181845(Traditional)
ATTN: Jim  Barley                 PHONE NO : 949 4333058 
22715 Holyrood Avenue             SE DECISION MADE: 25-NOV-19
Maple Ridge  CA V2X 6E7           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SDS1.2 dental implant
SDS Swiss Dental Solutions AG     510(k) NO: K181953(Traditional)
ATTN: Martin  Chares              PHONE NO : 417 15563670 
Konstanzerstrasse 11              SE DECISION MADE: 20-NOV-19
Kreuzlingen  CH 8280              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R)
Sturdy Industrial Co., Ltd        510(k) NO: K181993(Traditional)
ATTN: Wolfgang  Huang             PHONE NO : 886 2 29815245 601
No. 168 Sec. 1, Zhongxing Road, WuSE DECISION MADE: 01-NOV-19
New Taipei City  TW 24872         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PFC SIGMA Knee System
DePuy Orthopaedics, Inc.          510(k) NO: K182301(Traditional)
ATTN: Kathy  Harris               PHONE NO : 574 3727020 
700 Orthopaedic Drive             SE DECISION MADE: 08-NOV-19
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Silicone Foley Catheter
Biosensors International Pte Ltd  510(k) NO: K182463(Traditional)
ATTN: Lor Yen Yin                 PHONE NO : 65 6213 5777 538
36 Jalan Tukang                   SE DECISION MADE: 06-NOV-19
Singapore  SG 619266              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ROSA Bracket
GNI Co., LTD                      510(k) NO: K182672(Traditional)
ATTN: Duk Soo Kim                 PHONE NO : 82 505 6008880 
5F 501, 63-12 DongtancheomdansaneoSE DECISION MADE: 15-NOV-19
Hwaseong  KR 18469                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DEXIS CariVu 3-in-1 by KaVo
Kaltenbach & Voigt GmbH           510(k) NO: K182712(Traditional)
ATTN: Stefan  Trampler            PHONE NO : 49 7351 563515 
Bismarckring 39                   SE DECISION MADE: 23-NOV-19
Biberach  DE 88440                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JTL-250-01
Jointechlabs, Inc.                510(k) NO: K182732(Traditional)
ATTN: Thomas  Lawson              PHONE NO : 773 9541076 
8 Graystone Court                 SE DECISION MADE: 18-NOV-19
North Barrington IL  60010        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TRAUS Dental Handpieces
Saeshin Precision Co., Ltd.       510(k) NO: K182892(Traditional)
ATTN: Choi  Jong Woo              PHONE NO : 82 53 5872345 
52, Secheon-ro 1-gil, Dasa-eup, DaSE DECISION MADE: 26-NOV-19
Daegu  KR 42921                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FluoroCal
Bisco, Inc                        510(k) NO: K182917(Traditional)
ATTN: Ryan  Hobson                PHONE NO : 847 5346000 
1100 W Irving Park Rd             SE DECISION MADE: 18-NOV-19
Schaumburg IL  60193              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BIO-RAY A-1 Anchor Screw System
Microware Precision Co., Ltd.     510(k) NO: K182929(Traditional)
ATTN: Harrison  Du                PHONE NO : 886 4 24636275 100
No. 12, Keyuan 2nd Rd., Situn DistSE DECISION MADE: 06-NOV-19
Taichung  TW 40763                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3
Philips Medizin Systeme Boeblingen510(k) NO: K182979(Special)
ATTN: Markus  Stacha              PHONE NO : 49 7031 4632840 
Hewlett-Packard Str. 2            SE DECISION MADE: 19-NOV-19
Boeblingen  DE 71034              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VPro5
Propel Orthodontics LLC           510(k) NO: K183018(Traditional)
ATTN: Bryce  Way                  PHONE NO : 408 3945851 
394 South Abbott Ave              SE DECISION MADE: 01-NOV-19
Milpitas CA  95035                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digital Thermometer
Joytech Healthcare Co.,Ltd        510(k) NO: K183393(Traditional)
ATTN: Ren  Yunhua                 PHONE NO : 86 571 81957767 
No. 365 Wuzhou Road, Yuhang EconomSE DECISION MADE: 18-NOV-19
Hangzhou  CN 311100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head
Zimmer, Inc.                      510(k) NO: K183457(Traditional)
ATTN: Rebecca  Nofiz              PHONE NO : 574 3732934 
P.O. Box 708                      SE DECISION MADE: 05-NOV-19
Warsaw IN  46581-0708             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Allcem, Allcem Core
Dentscare LTDA                    510(k) NO: K183465(Traditional)
ATTN: Roberta  Uyara              PHONE NO : 55 47 34416131 
Av. Edgar Nelson Meister, 474     SE DECISION MADE: 02-NOV-19
Joinville  BR 89219-501           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KeyPrint KeySplint Soft
Keystone Industries               510(k) NO: K183598(Traditional)
ATTN: Negar  Movahed              PHONE NO : 800 3333131 
480 S. Democrat Rd                SE DECISION MADE: 15-NOV-19
Gibbstown NJ  08027               510(k) STATEMENT
                                                    

DEVICE: EBA One Nailing System
CITIEFFE S.r.l.                   510(k) NO: K183666(Traditional)
ATTN: Stefano  Pullega            PHONE NO : 0039 051 721850 
Via Armaroli, 21                  SE DECISION MADE: 14-NOV-19
Calderara di Reno  IT 40012       510(k) STATEMENT
                                                    

DEVICE: Vivid Aligners
Orthodent Laboratory, Inc.        510(k) NO: K190003(Traditional)
ATTN: Michael  Wright             PHONE NO : 716 8391900 
6325 Sheridan Drive               SE DECISION MADE: 06-NOV-19
Buffalo NY  14221                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WellDoc BlueStar
WellDoc, Inc.                     510(k) NO: K190013(Traditional)
ATTN: Caroline  York              PHONE NO : 443 6923100 
10221 Wincopin Circle, Suite 150  SE DECISION MADE: 04-NOV-19
Columbia MD  21044                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Foryou NPWT Dressing Kit
4L Health Co., Ltd.               510(k) NO: K190119(Traditional)
ATTN: Jackie  Jian                PHONE NO : 86 752 5300546 
No. 108, Dongxin Rd, DongJiang Hi-SE DECISION MADE: 01-NOV-19
Huizhou  CN 516000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LARS AC Band Device
Corin USA                         510(k) NO: K190143(Traditional)
ATTN: Lucinda  Gerber             PHONE NO : 772 3212478 
12750 Citrus Park Lane, Suite 120 SE DECISION MADE: 04-NOV-19
Tampa FL  33625                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MucoPEG
SunBio, Inc.                      510(k) NO: K190144(Traditional)
ATTN: Sun S. Kim                  PHONE NO : 925 8760439 
95 Sanbon-ro                      SE DECISION MADE: 05-NOV-19
Gunpo-si  KR 15849                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MDT2 BLE Self-Monitoring Blood Glucose System
EPS Bio Technology Corp.          510(k) NO: K190189(Special)
ATTN: Cynthia  Hung               PHONE NO : 886 36686866 
No. 8 R&D RD.III Hsinchu Science PSE DECISION MADE: 01-NOV-19
Hsinchu  TW 30077                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WV1 Endoscope
270Surgical Ltd                   510(k) NO: K190190(Traditional)
ATTN: Avi  Levy                   PHONE NO : 972 77 9031100 
4 Arie Regev Street               SE DECISION MADE: 01-NOV-19
Natanya  IL 4250212               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TAP Blood Collection Device
Seventh Sense Biosystems, Inc.    510(k) NO: K190225(Traditional)
ATTN: Tim  Richards               PHONE NO : 617 5477246 
200 Boston Avenue, Suite 3700     SE DECISION MADE: 05-NOV-19
Medford MA  02155                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hydrofera Blue READY - Border
Hydrofera, LLC                    510(k) NO: K190268(Traditional)
ATTN: Sean  Anderson              PHONE NO : 860 3377462 117
340 Progress Drive                SE DECISION MADE: 06-NOV-19
Manchester CT  06042              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dornier Ureteral Stent
Dornier MedTech America Inc.      510(k) NO: K190312(Traditional)
ATTN: John  Hoffer                PHONE NO : 770 5146163 
1155 Roberts Blvd, Suite 100      SE DECISION MADE: 15-NOV-19
Kennesaw GA  30144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DRX-Evolution/Plus with Dual Energy
Carestream Health, Inc.           510(k) NO: K190330(Traditional)
ATTN: Carolyn  Wagner             PHONE NO : 585 6276588 
150 Verona Street                 SE DECISION MADE: 04-NOV-19
Rochester NY  14608               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Applied Medical Laparoscopic Linear Cutter
Applied Medical Resources Corporat510(k) NO: K190331(Traditional)
ATTN: Aditi  Iyengar              PHONE NO : 949 7138007 
22872 Avenida Empresa             SE DECISION MADE: 22-NOV-19
Rancho Santa Margarita CA  92688  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MIMOSA Imager
MIMOSA Diagnostics Inc            510(k) NO: K190334(Traditional)
ATTN: Yuan  Fang                  PHONE NO : 844 6466721 
1 Yonge St Suite 201              SE DECISION MADE: 01-NOV-19
Toronto  CA M5E1E5                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GSP Neonatal Total Galactose kit
PerkinElmer Inc.                  510(k) NO: K190335(Traditional)
ATTN: Brian  Ciccariello          PHONE NO : 781 6635651 
940 Winter Street                 SE DECISION MADE: 06-NOV-19
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DePuy Corail AMT Hip Prosthesis
DePuy (Ireland)                   510(k) NO: K190344(Traditional)
ATTN: Kathy  Harris               PHONE NO : 574 6071079 
Loughbeg Ringaskiddy              SE DECISION MADE: 01-NOV-19
Co. Cork  IE                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TDM Plate and Screw Systems
TDM Co. Ltd.                      510(k) NO: K190391(Traditional)
ATTN: Yougdae  Kim                PHONE NO : 82 62 6027460 
69, Cheomdan Venture so-ro, 37 beoSE DECISION MADE: 15-NOV-19
Gwangju  KR 61003                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA
Immunalysis Corporation           510(k) NO: K190397(Traditional)
ATTN: Yang  Yang                  PHONE NO : 909 4820480 
829 Towne Center Drive            SE DECISION MADE: 15-NOV-19
Pomona CA  91767                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Engage™ Partial Knee System
Engage UNI, LLC                   510(k) NO: K190439(Traditional)
ATTN: Nicholas  Slater            PHONE NO : 833 3642432 
5931 Brick Court, Suite 130       SE DECISION MADE: 21-NOV-19
Winter Park FL  32792             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed ViewFlex™ Xtra ICE Catheter
Sterilmed, Inc.                   510(k) NO: K190478(Traditional)
ATTN: Jan  Flegeau                PHONE NO : 786 5755903 
5010 Cheshire Pkwy N, Suite 2     SE DECISION MADE: 14-NOV-19
Plymouth MN  55446                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infant Incubator
Ningbo David Medical Device Co.,Lt510(k) NO: K190494(Traditional)
ATTN: Lin  Dingyu                 PHONE NO : 86 574 87800008 
No.2, Keyuan Road, Shipu TechnologSE DECISION MADE: 25-NOV-19
Ningbo  CN 315731                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ziehm 8000
Ziehm Imaging GmbH                510(k) NO: K190497(Traditional)
ATTN: Steve  Seeman               PHONE NO : 49 0 9112172219 
Donaustrasse 31                   SE DECISION MADE: 20-NOV-19
Nuremberg  DE 90451               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare
Intelligent Endoscopy             510(k) NO: K190512(Traditional)
ATTN: Melissa  Clark              PHONE NO : 336 6084375 
4740 Commercial Park Ct, Suite 1  SE DECISION MADE: 22-NOV-19
Clemmons NC  27012                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Color Liquid, Vita Liquid
Zirkonzahn srl                    510(k) NO: K190518(Traditional)
ATTN: Julian  Steger              PHONE NO : 39 0474 066660 
Via An der Ahr 7                  SE DECISION MADE: 22-NOV-19
Gais  IT 39030                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter)
Allwin Medical Devices, Inc.      510(k) NO: K190522(Traditional)
ATTN: Digish  Mehta               PHONE NO : 714 5721709 
3305 E. Miraloma Avenue, Suite 176SE DECISION MADE: 14-NOV-19
Anaheim CA  92806                 510(k) STATEMENT
                                                    

DEVICE: SOZO
ImpediMed Limited                 510(k) NO: K190529(Traditional)
ATTN: Catherine  Kingsford        PHONE NO : 61 7 38603703 
Unit 1, 50 Parker Court           SE DECISION MADE: 25-NOV-19
Pinkenba  AU 4008                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MTS225 and MTS300 Multiple Tray Sterilization Systems
PMBS, LLC                         510(k) NO: K190541(Traditional)
ATTN: Michele E. Mauzerall        PHONE NO : 908 3007093 
5419 Delette Avenue South         SE DECISION MADE: 05-NOV-19
St. Petersburg FL  33707          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XIHPOS™ ZFUZE™ Interbody Fusion System
DiFusion Technologies             510(k) NO: K190544(Traditional)
ATTN: Derrick  Johns              PHONE NO : 512 2843338 
1624 Headway Circle               SE DECISION MADE: 01-NOV-19
Austin TX  78754                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: StoneBite and StoneBite scan
Dreve Dentamid GmbH               510(k) NO: K190571(Abbreviated)
ATTN: Reiner  Altmann             PHONE NO : 49 2303 880714 
Max-Planck-Strasse 31             SE DECISION MADE: 07-NOV-19
Unna  DE 59423                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: World Knee Total Knee Systems
Signature Orthopaedics Pty Ltd.   510(k) NO: K190577(Traditional)
ATTN: Declan  Brazil              PHONE NO : 61 2 94285181 
7 Sirius Road                     SE DECISION MADE: 27-NOV-19
Lane Cove  AU 2066                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)
Allwin Medical Devices, Inc.      510(k) NO: K190590(Traditional)
ATTN: Digish  Mehta               PHONE NO : 714 5721709 
3305 E. Miraloma Avenue, Suite 176SE DECISION MADE: 25-NOV-19
Anaheim CA  92806                 510(k) STATEMENT
                                                    

DEVICE: Mei Ceramic Bracket
Orthosun Co., Ltd.                510(k) NO: K190608(Traditional)
ATTN: Ju-Sung  Lee                PHONE NO : 82 32 5452825 
2F, 112, Pyeongni-gil, Gyeyang-gu SE DECISION MADE: 04-NOV-19
Incheon  KR 21008                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Omics Core
NantHealth, Inc.                  510(k) NO: K190661(Traditional)
ATTN: Aleece  Nolasco             PHONE NO : 310 4057549 
9920 Jefferson Blvd               SE DECISION MADE: 09-NOV-19
Culver City CA  90232             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)
KCI USA, Inc.                     510(k) NO: K190697(Traditional)
ATTN: Patricia  Lopez             PHONE NO : 210 2556727 
6203 Farinon Drive                SE DECISION MADE: 22-NOV-19
San Antonio TX  78249             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EliA SymphonyS Immunoassay
Phadia AB                         510(k) NO: K190710(Traditional)
ATTN: Carina  Magnusson           PHONE NO : 46 18 165000 
Rapsgatan 7P                      SE DECISION MADE: 29-NOV-19
Uppsala  SE SE 754 50             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LongBow Ti
Life Spine Inc.                   510(k) NO: K190721(Traditional)
ATTN: Angela  Batker              PHONE NO : 847 8846117 
13951 S Quality Drive             SE DECISION MADE: 14-NOV-19
Huntley IL  60142                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cadwell Bolt Software
Cadwell Industries, Inc.          510(k) NO: K190760(Traditional)
ATTN: Emily  Whitehead            PHONE NO : 509 7356481 
909 N. Kellogg Street             SE DECISION MADE: 23-NOV-19
Kennewick WA  99336               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)
Reed Medical (Zhejiang) Co., Ltd. 510(k) NO: K190797(Traditional)
ATTN: Lu Zhong Zhong              PHONE NO : 86 573 85135876 
8th Floor, 10th Building, No. 988 SE DECISION MADE: 18-NOV-19
Pinghu  CN 314200                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PENTAX Medical Video Upper GI Scopes (EG Family)
PENTAX of America, Inc.           510(k) NO: K190799(Traditional)
ATTN: William  Goeller            PHONE NO : 201 5712300 2318
3 Paragon Drive                   SE DECISION MADE: 12-NOV-19
Montvale NJ  07645-1782           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Optimus NEURO System - Sterile Kit
Osteonic Co., Ltd                 510(k) NO: K190811(Traditional)
ATTN: Choi  Se Young              PHONE NO : 82 2 69028415 
505-3Ho, 1206Ho, 38, Digital-ro 29SE DECISION MADE: 27-NOV-19
Seoul  KR 08381                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vial Adapter Ø20 mm , Vial Adapter Ø13 mm
Avenir Performance Europeenne Medi510(k) NO: K190816(Traditional)
ATTN: Fatoumata  Dao              PHONE NO : 0033 164 785100 
ZI Route de Souppes               SE DECISION MADE: 19-NOV-19
Château-Landon  FR 77570          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD Acute Central Line
Bard Access Systems, Inc. (Bard ha510(k) NO: K190855(Third Party - Traditional)
ATTN: Sean J. Loring              PHONE NO : 801 5225634 
605 North 5600 West               SE DECISION MADE: 01-NOV-19
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Cleerly Labs
Cleerly Inc                       510(k) NO: K190868(Traditional)
ATTN: Kimberly  Elmore            PHONE NO : 646 3624255 
101 Greenwich St, Suite 11C       SE DECISION MADE: 05-NOV-19
New York NY  10006                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioGenesis Fertility Lubricant
Good Clean Love, Inc.             510(k) NO: K190872(Traditional)
ATTN: Wendy  Strgar               PHONE NO : 541 3444483 
207 W. 5th Avenue                 SE DECISION MADE: 07-NOV-19
Eugene OR  97401                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sight OLO
Sight Diagnostics Ltd.            510(k) NO: K190898(Traditional)
ATTN: Sarah  Levy                 PHONE NO : 972 3 5418580 
Derech Menachem Begin 23          SE DECISION MADE: 01-NOV-19
Tel Aviv  IL                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Physica KR Liner and SMR Reverse Humeral Liner
LimaCorporate                     510(k) NO: K190911(Special)
ATTN: Roberto  Gabetta            PHONE NO : 39 338 6439379 
Via Nazionale, 52                 SE DECISION MADE: 26-NOV-19
Villanova di San Daniele del Friul510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Salem Sump Dual Lumen Stomach Tube with ENFit Connection
Cardinal Health                   510(k) NO: K190923(Traditional)
ATTN: Alexis  Erazo               PHONE NO : 508 6183727 
777 West Street                   SE DECISION MADE: 07-NOV-19
Mansfield MA  02048               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hypotension Decision Assist
Directed Systems Ltd              510(k) NO: K190955(Traditional)
ATTN: Mark S. Leaning             PHONE NO : 011 44 7552747389 
St John's Innovation Centre, CowleSE DECISION MADE: 27-NOV-19
Cambridge  GB CB4 0WS             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neodent Implant System
JJGC Industria e Comercio de Mater510(k) NO: K190958(Traditional)
ATTN: Mariana Soares Hartmann     PHONE NO : 55 41 21694058 
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 09-NOV-19
Curitiba  BR 81270-200            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Navina Smart System, Navina Classic System
Dentsply Sirona                   510(k) NO: K190977(Traditional)
ATTN: Karl  Nittinger             PHONE NO : 717 8494424 
221 West Philadelphia Street, SuitSE DECISION MADE: 22-NOV-19
York PA  17401                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BA Pit & Fissure Sealant
Apex Dental Materials, Inc.       510(k) NO: K190998(Abbreviated)
ATTN: Scott  Lamerand             PHONE NO : 847 7191133 
330 Telser Road                   SE DECISION MADE: 08-NOV-19
Lake Zurich IL  60047             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: COPAL exchange G Hip and Knee Spacers
Heraeus Medical GmbH              510(k) NO: K191016(Traditional)
ATTN: Ljuba  Jitaau               PHONE NO : 49 6181 352339 
Philipp-Reis-Str. 8/13            SE DECISION MADE: 01-NOV-19
Werheim  DE 61273                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MEDIP PRO
MEDICALIP Co., Ltd                510(k) NO: K191026(Traditional)
ATTN: Yoon Bo Chung               PHONE NO : 82 2 21359148 
7F Changkyung Building, 174, YulgoSE DECISION MADE: 07-NOV-19
Jongno-gu  KR 03127               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KLS Martin Individual Patient Solutions
KLS-Martin L.P.                   510(k) NO: K191028(Traditional)
ATTN: Jennifer  Damato            PHONE NO : 800 6251557 
11201 Saint Johns Industrial ParkwSE DECISION MADE: 22-NOV-19
Jacksonville FL  32246            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: fMRI Hardware System
NordicNeurolab AS                 510(k) NO: K191032(Traditional)
ATTN: Chandana Gurung Bhandari    PHONE NO : 47 550 707095 
Mollendalsveien1                  SE DECISION MADE: 27-NOV-19
Bergen  NO 5009                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADI TiDAL Osteotomy Wedge
Additive Device, Inc. (ADI) d/b/a 510(k) NO: K191047(Traditional)
ATTN: Nathan  Evans               PHONE NO : 984 8880593 
311 W Corporation St.             SE DECISION MADE: 05-NOV-19
Durham NC  27701                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Healy
TimeWaver Production GmbH         510(k) NO: K191075(Traditional)
ATTN: Martin  Wittmann            PHONE NO : 49 3391 4002211 
Schloss Kranzlin Darritzer Strab 6SE DECISION MADE: 22-NOV-19
Kranzlin  DE 16818                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Parkell Desensitizer Gel
Parkell, Inc.                     510(k) NO: K191103(Traditional)
ATTN: David  Mott                 PHONE NO : 631 3891545 
300 Executive Drive               SE DECISION MADE: 22-NOV-19
Edgewood NY  11717                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HeraBEAT™ US
HeraMED Ltd.                      510(k) NO: K191110(Traditional)
ATTN: Dganit  Litinsky            PHONE NO : 972 9 8803010 
6 Meir Ariel St.                  SE DECISION MADE: 14-NOV-19
Netanya  IL 4059300               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
Luminex Molecular Diagnostics, Inc510(k) NO: K191160(Special)
ATTN: Tina  Ip                    PHONE NO : 437 3715631 
439 University Avenue             SE DECISION MADE: 04-NOV-19
Toronto  CA M5g 1y8               510(k) STATEMENT
                                                    

DEVICE: xTAG Gastrointestinal Pathogen Panel (GPP)
Luminex Molecular Diagnostics, Inc510(k) NO: K191161(Special)
ATTN: Tina  Ip                    PHONE NO : 1 437 3715631 
439 University Ave.               SE DECISION MADE: 12-NOV-19
Toronto  CA M5G 1Y8               510(k) STATEMENT
                                                    

DEVICE: EchoGo Core
Ultromics Ltd                     510(k) NO: K191171(Traditional)
ATTN: Melissa  Clark              PHONE NO : 203 9064644 
Stansfeld Park, Quarry Road       SE DECISION MADE: 13-NOV-19
Oxford  GB OX3 8SB                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EM SA Implant System
Hiossen, Inc.                     510(k) NO: K191201(Traditional)
ATTN: Peter  Lee                  PHONE NO : 888 6780001 
85 Ben Fairless Drive             SE DECISION MADE: 15-NOV-19
Fairless Hills PA  19030          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves
O & M Halyard, Inc.               510(k) NO: K191230(Abbreviated)
ATTN: Steve  Dowdlley             PHONE NO : 1 678 4518062 
9120 Lockwood Blvd                SE DECISION MADE: 08-NOV-19
Mechanicsville VA  23116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M™ Attest™ Steam Chemical Integrators
3M Company                        510(k) NO: K191236(Traditional)
ATTN: Mary  Fretland              PHONE NO : 651 7370929 
3M Center, Building 275-5W-06     SE DECISION MADE: 22-NOV-19
St. Paul MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CERENOVUS Large Bore Catheter
Codman & Shurtleff, Inc.          510(k) NO: K191237(Traditional)
ATTN: Kirsten  Franco             PHONE NO : 484 8687991 
325 Paramount Drive               SE DECISION MADE: 08-NOV-19
Raynham MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SmartSPACE Shoulder System
TechMah Medical LLC               510(k) NO: K191247(Traditional)
ATTN: Mohamed R. Mahfouz          PHONE NO : 1 877 7256920 104
2099 Thunderhead Rd., Suite 302   SE DECISION MADE: 15-NOV-19
Knoxville TN  37922               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RSI-MRI+
MultiModal Imaging Services Corpor510(k) NO: K191278(Traditional)
ATTN: Stephen  Kosnosky           PHONE NO : 619 3400503 
4747 Executive Dr, Suite 820      SE DECISION MADE: 19-NOV-19
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: E-100 Electrosurgical Generator, SynchroSeal
Intuitive Surgical, Inc.          510(k) NO: K191280(Traditional)
ATTN: Melissa  Gonzalez           PHONE NO : 408 5238684 
1266 Kifer Road                   SE DECISION MADE: 14-NOV-19
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family
PENTAX of America, Inc.           510(k) NO: K191282(Traditional)
ATTN: William  Goeller            PHONE NO : 201 5712300 2318
3 Paragon Drive                   SE DECISION MADE: 08-NOV-19
Montvale NJ  07645-1782           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System
Ascensia Diabetes Care            510(k) NO: K191286(Special)
ATTN: Stacie  Geffner-Atiya       PHONE NO : 914 2668531 
100 Summit Lake Drive             SE DECISION MADE: 08-NOV-19
Valhalla NY  10595                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Anhui Powerguard Technology Co.,Lt510(k) NO: K191292(Traditional)
ATTN: Nike  Dai                   PHONE NO : 
North Development Zone, Lingbi CouSE DECISION MADE: 05-NOV-19
Jiujiang  CN 234200               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EthanZir Zirconia
Besorah Dental Solutions NZ Limite510(k) NO: K191304(Traditional)
ATTN: Jobin  Jose                 PHONE NO : 64 2 11268337 
17/9 Chonny Crescent, Manurewa    SE DECISION MADE: 04-NOV-19
Auckland  NZ 2102                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Perfect PFE
TensCare Ltd.                     510(k) NO: K191312(Traditional)
ATTN: Andrew  Brown               PHONE NO : 44 0 1372723434 
9 Blenheim Road, Longmead BusinessSE DECISION MADE: 01-NOV-19
Epsom  GB KT19 9BE                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DemeDIOX Barbed Absorbable Surgical Suture
DemeTECH Corporation              510(k) NO: K191361(Traditional)
ATTN: Tracy  Chadwrick            PHONE NO : 305 8241048 
14175 NW 60th Ave                 SE DECISION MADE: 07-NOV-19
Miami Lakes FL  33014             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FiberTak Button
Arthrex Inc.                      510(k) NO: K191426(Special)
ATTN: Ivette  Galmez              PHONE NO : 1 239 6435553 71263
1370 Creekside Boulevard          SE DECISION MADE: 26-NOV-19
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ECG Cable
Shenzhen Changke Connect Electroni510(k) NO: K191428(Traditional)
ATTN: Yahui  Zhou                 PHONE NO : 86 136 13012560 
A2-4th floor of Xiang dali TechnolSE DECISION MADE: 27-NOV-19
Longgang District, Shenzhen  CN   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Asahi PTCA Guide Wire Asahi SION Series
Asahi Intecc Co., LTD.            510(k) NO: K191464(Traditional)
ATTN: Yasuyuki  Kawahara          PHONE NO : 81 561 561859 
3-100Akatsuki-cho                 SE DECISION MADE: 21-NOV-19
Seto  JP 489-0071                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SandShark Injectable Anchor (SIA) System
Stimwave Technologies Inc.        510(k) NO: K191466(Traditional)
ATTN: Elizabeth  Greene           PHONE NO : 1 800 9655134 
1310 Park Central Boulevard South SE DECISION MADE: 07-NOV-19
Pompano Beach FL  33064           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AEON-C Stand Alone System
Huvexel Co., Ltd                  510(k) NO: K191477(Traditional)
ATTN: Sung Kyu Hur                PHONE NO : 82 31 7763690 
101-105 Megacenter, SKn TechnoparkSE DECISION MADE: 13-NOV-19
Seongnam-si  KR 13207             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SAM IO Intraosseous Access System
SAM® Medical Products, Inc.       510(k) NO: K191488(Traditional)
ATTN: Jeff  Lipps                 PHONE NO : 1 503 6395474 
27350 SW 95th Ave, Suite 3038     SE DECISION MADE: 21-NOV-19
Wilsonville OR  97070             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NextDent Denture 3D+
Vertex-Dental BV                  510(k) NO: K191497(Abbreviated)
ATTN: Loes  Vloet-Emonts          PHONE NO : 31 88 6160430 
Centurionbaan 190                 SE DECISION MADE: 01-NOV-19
Soesterberg  NL 3769 AV           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Heraeus Peripheral Guidewire
Heraeus Medical Components, LLC   510(k) NO: K191502(Traditional)
ATTN: Chelsea  Pioske             PHONE NO : 763 2256500 
2605 Fernbrook Lane North, Suite JSE DECISION MADE: 26-NOV-19
Plymouth MN  55447                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Visalys CemCore, Visalys Cem Core Try In Paste
Kettenbach GmbH & Co. KG          510(k) NO: K191527(Traditional)
ATTN: Katja  Simon                PHONE NO : 49 2774 7050 
Im Heerfeld 7                     SE DECISION MADE: 08-NOV-19
Eschenburg  DE 35713              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Progenikine   Concentrating System 25 mL System
Emcyte Corporation                510(k) NO: K191564(Traditional)
ATTN: Patrick  Pennie             PHONE NO : 239 4817725 
4331 Veronica S. Shoemaker Blvd, SSE DECISION MADE: 07-NOV-19
Fort Meyers FL  33916             510(k) STATEMENT
                                                    

DEVICE: Infrared Thermometer Model MD-H30
Guangzhou Berrcom Medical Device C510(k) NO: K191570(Traditional)
ATTN: Zhigang  Du                 PHONE NO : 86 20 34938449 
No.38 Huanzhen Xi Road, Dagang TowSE DECISION MADE: 13-NOV-19
Guangzhou  CN 511470              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stealth Autoguide System, Midas Rex Legend Depth Stop System
Medtronic Navigation, Inc.        510(k) NO: K191597(Traditional)
ATTN: Jason  Woehrle              PHONE NO : 949 3991509 
826 Coal Creek Circle             SE DECISION MADE: 01-NOV-19
Louisville CO  80027              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Delta Multihole TT Pro Acetabular System
Limacorporate S.p.A.              510(k) NO: K191622(Traditional)
ATTN: Roberto  Gabetta            PHONE NO : 39 04 32945511 
Via Nazionale 52                  SE DECISION MADE: 01-NOV-19
Villanova di San Daniele del Friul510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZMAXX Dental Zirconia Blanks
ZMAXX Bioceramics LLC             510(k) NO: K191631(Traditional)
ATTN: Josef  Wu                   PHONE NO : 1 510 7741317 
231 Pelican Ct.                   SE DECISION MADE: 01-NOV-19
Foster CA  94404                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Scan Abutments and Comfort Caps
Dentium Co., Ltd.                 510(k) NO: K191634(Traditional)
ATTN: Byung-sun  Kim              PHONE NO : 82 70 70988806 
150, Eondong-ro, Giheung-gu       SE DECISION MADE: 04-NOV-19
Yongin-si  KR 446-914             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LEGION System
Alcon Research, LLC               510(k) NO: K191650(Traditional)
ATTN: Nickerson  Hill             PHONE NO : 817 3025700 
6201 South Freeway                SE DECISION MADE: 01-NOV-19
Fort Worth TX  76134              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex Nano SwiveLock Suture Anchor
Arthrex Inc.                      510(k) NO: K191651(Traditional)
ATTN: Rebecca R. Homan            PHONE NO : 239 6435553 73429
1370 Creekside Boulevard          SE DECISION MADE: 06-NOV-19
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Upper Arm Blood Pressure Monitor
Famidoc Technology Company Limited510(k) NO: K191673(Traditional)
ATTN: Leon  Cao                   PHONE NO : 86 769 89272488 
No. 212 Yilong Road, Hexi IndustriSE DECISION MADE: 27-NOV-19
Dongguan  CN 523853               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BC-5
Reveallux, Corp                   510(k) NO: K191693(Abbreviated)
ATTN: Justin D Linn               PHONE NO : 402 7503535 
4508 38th, Suite 230              SE DECISION MADE: 01-NOV-19
Columbus NE  68601                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arcus Head Fixation Frame
MRI Interventions, Inc.           510(k) NO: K191701(Traditional)
ATTN: Pete  Piferi                PHONE NO : 949 9006833 
5 Musick                          SE DECISION MADE: 15-NOV-19
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MatriStem UBM Pericardial Patch
Acell, Inc.                       510(k) NO: K191734(Traditional)
ATTN: Michelle  Huettner          PHONE NO : 765 4648198 135
6640 Eli Whitney Drive Suite 200  SE DECISION MADE: 22-NOV-19
Columbia MD  21046                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SMR TT Augmented Glenoid System
Limacorporate S.p.A               510(k) NO: K191746(Traditional)
ATTN: Michela  Zanotto            PHONE NO : 39 043 2945511 
via Nazionale 52                  SE DECISION MADE: 22-NOV-19
Villanova di San Daniele del Friul510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hair Growth System
Kunshan Bella Optical technology C510(k) NO: K191754(Traditional)
ATTN: Wu  Xuefeng                 PHONE NO : 86 512 36852252 
Plant 2, Kunshan Development Zone,SE DECISION MADE: 22-NOV-19
Kunshan  CN 215300                510(k) STATEMENT
                                                    

DEVICE: Gabriel Feeding Tube with Balloon, and EnFit Connector
Syncro Medical Innovations, Inc.  510(k) NO: K191784(Traditional)
ATTN: Sabry  Gabriel              PHONE NO : 478 3358311 
515 Mulberry St Suite 200         SE DECISION MADE: 15-NOV-19
Macon GA  31201-6308              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VS3-IR
Medtronic                         510(k) NO: K191851(Traditional)
ATTN: Alex  Chanin                PHONE NO : 972 3 9244339 
20 Hamagshimim St                 SE DECISION MADE: 25-NOV-19
Petach Tikva, Hamerkaz  IL 49348  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SmartLite Pro Modular LED Curing Light
Dentsply Sirona                   510(k) NO: K191865(Traditional)
ATTN: Karl  Nittinger             PHONE NO : 717 849 4424
221 West Philadelphia Street, SuitSE DECISION MADE: 20-NOV-19
York PA  17401                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SOMATOM X.cite
Siemens Medical Solutions USA, Inc510(k) NO: K191891(Traditional)
ATTN: Tabitha  Estes              PHONE NO : 865 8044553 
810 Innovation Drive              SE DECISION MADE: 06-NOV-19
Knoxville TN  37932               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BruxZir GT (Gum Tissue) Color
Prismatik Dentalcraft, Inc.       510(k) NO: K191903(Traditional)
ATTN: Mythili  Reguraman          PHONE NO : 949 4402739 
2212 Dupont Dr.                   SE DECISION MADE: 22-NOV-19
Irvine CA  92612                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3Shape Splint Design
3Shape A/S                        510(k) NO: K191911(Traditional)
ATTN: Shreyosi  Chakraborty       PHONE NO : 45 702 72620 
                                  SE DECISION MADE: 27-NOV-19
Copenhagen  DK 1060               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Thermo Scientific Sensititre ARIS HiQ System
Thermo Fisher Scientific          510(k) NO: K191914(Traditional)
ATTN: Cynthia  Knapp              PHONE NO : 800 87189093 224117
1 Thermo Fisher Way               SE DECISION MADE: 06-NOV-19
Oakwood Village OH  440146        510(k) STATEMENT
                                                    

DEVICE: Thermo Scientific Sensititre ARIS HiQ System
Thermo Fisher Scientific          510(k) NO: K191918(Traditional)
ATTN: Cynthia  Knapp              PHONE NO : 800 8718909 322411
1 Thermo Fisher Way               SE DECISION MADE: 06-NOV-19
Oakwood Village OH  440146        510(k) STATEMENT
                                                    

DEVICE: Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments
Cochlear Americas                 510(k) NO: K191921(Traditional)
ATTN: Chinda  Hemmavanh           PHONE NO : 303 2642752 
13059 E Peakview Avenue           SE DECISION MADE: 15-NOV-19
Centennial CO  80111              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QuantX Breast MRI Biopsy Guidance Plugin
Qlarity Imaging                   510(k) NO: K191959(Traditional)
ATTN: Robert  Tomek               PHONE NO : 773 9604670 
222 W Merchndise Mart Plaza Suite SE DECISION MADE: 08-NOV-19
Chicago IL  60654                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OrthoGold
Tissue Regeneration Technologies  510(k) NO: K191961(Traditional)
ATTN: John  Warlick               PHONE NO : 404 4026844 
251 Heritage Walk                 SE DECISION MADE: 26-NOV-19
Woodstock GA  30188               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARIX Wrist System
Jeil Medical Corporation          510(k) NO: K191972(Traditional)
ATTN: Ahhyeon  Woo                PHONE NO : 82 2 8503591 
702,703,704,705,706,804,805,807,81SE DECISION MADE: 12-NOV-19
Seoul  KR 08378                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive AttraX Putty
NuVasive, Incorporated            510(k) NO: K191974(Traditional)
ATTN: Jessica  LeBlanc            PHONE NO : 858 9093302 
7475 Lusk Blvd.                   SE DECISION MADE: 03-NOV-19
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Piper GO-IO Intraosseous Infusion System
Piper Access, LLC                 510(k) NO: K191976(Third Party - Traditional)
ATTN: Jacob  Lee                  PHONE NO : 801 5225823 
3981 South 700 East Suite #15     SE DECISION MADE: 13-NOV-19
Salt Lake City UT  84107          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CLEARFIL MAJESTY ES Flow
Kuraray Noritake Dental Inc.      510(k) NO: K191980(Traditional)
ATTN: Yasujiro  Ohara             PHONE NO : 81 3 67011736 
Ote Center Bldg. 7F, 1-1-3, OtemacSE DECISION MADE: 18-NOV-19
Chiyoda-ku  JP 100-0004           510(k) STATEMENT
                                                    

DEVICE: DESS Dental Smart Solutions
Terrats Medical SL                510(k) NO: K191986(Traditional)
ATTN: Roger  Terrats              PHONE NO : 34 935 646006 
Carrer Mogoda 75-99               SE DECISION MADE: 10-NOV-19
Barbera del Valles  ES 08210      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Orapeutic
Forward Science                   510(k) NO: K191987(Traditional)
ATTN: Brian  Pikkula              PHONE NO : 855 6967254 
10401 Greenbough, Ste 100         SE DECISION MADE: 27-NOV-19
Stafford TX  77477                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1
Abbott Medical                    510(k) NO: K192019(Traditional)
ATTN: Richard  DeMello            PHONE NO : 978 5773400 
4 Robbins Road                    SE DECISION MADE: 08-NOV-19
Westford MA  01886                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Peridot Intervertebral body fusion System
GBS Commonwealth Co., Ltd.        510(k) NO: K192026(Traditional)
ATTN: Jimmy  Kim                  PHONE NO : 82 2 69254469 
C-309, Woolim Lion's Valley, 168, SE DECISION MADE: 26-NOV-19
Geumcheon-gu  KR 08507            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ophthalmic Yag Laser System YC-200
Nidek Co., Ltd.                   510(k) NO: K192045(Traditional)
ATTN: Tsutomu  Sunada             PHONE NO : 81 553 678901 
34-14 Maehama, Hiroishicho        SE DECISION MADE: 15-NOV-19
Gamagori  JP 443-0038             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Oryx Cervical Plate System
Innovasis, Inc.                   510(k) NO: K192049(Traditional)
ATTN: Marshall  McCarty           PHONE NO : 801 2612236 
614 East 3900 South               SE DECISION MADE: 08-NOV-19
Salt Lake City UT  84107          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO
Siemens Medical Solutions USA, Inc510(k) NO: K192061(Traditional)
ATTN: Alaine  Medio               PHONE NO : 865 2060337 
810 Innovation Drive              SE DECISION MADE: 21-NOV-19
Knoxville TN  37932               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EOSedge
EOS imaging                       510(k) NO: K192079(Traditional)
ATTN: Bernard  Ismael             PHONE NO : 33 155 256060 
10 rue Mercoeur                   SE DECISION MADE: 27-NOV-19
Paris  FR 75011                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iASSIST Knee System
Orthosoft Inc. (d/b/a Zimmer CAS) 510(k) NO: K192080(Traditional)
ATTN: Eduardo  Mendoza            PHONE NO : 514 8614074 312
75 Queen St., Suite 3300          SE DECISION MADE: 05-NOV-19
Montreal  CA H3C 2N6              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Combo Electrotherapy Device
Shenzhen Roundwhale Technology Co.510(k) NO: K192087(Traditional)
ATTN: Kevin  Zhang                PHONE NO : 86 755 23212776 
202, 2/F, Building 27, Dafa IndustSE DECISION MADE: 01-NOV-19
Shenzhen  CN 518108               510(k) STATEMENT
                                                    

DEVICE: CAPI 3 Immunotyping, Capillarys 3 Tera
Sebia                             510(k) NO: K192095(Traditional)
ATTN: Karen  Anderson             PHONE NO : 1 800 8356497 3704
1705 Corporate Drive Suite 400    SE DECISION MADE: 01-NOV-19
Norcross GA  30093                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Innonix Antiviral Child's Face Mask
Innonix Technologies Limited      510(k) NO: K192105(Traditional)
ATTN: Tommy  Lui                  PHONE NO : 85 225 422401 
13/F LiFung Centre, 2 On Ping StreSE DECISION MADE: 29-NOV-19
Siu Lek Yuen,Shatin  HK           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KOALA
IB Lab GmbH                       510(k) NO: K192109(Traditional)
ATTN: Richard  Ljuhar             PHONE NO : 43 190 51206 
Hietzinger Hauptstrasse 50/10     SE DECISION MADE: 05-NOV-19
Vienna  AT 1130                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DRSplus
CenterVue SpA                     510(k) NO: K192113(Traditional)
ATTN: Roberto  Gabriotti          PHONE NO : 39 04 95018399 
Via S. Marco 9H                   SE DECISION MADE: 15-NOV-19
Padova  IT 35129                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Small VBR™
ulrich GmbH & Co. KG              510(k) NO: K192117(Traditional)
ATTN: Christoph  Ulrich           PHONE NO : 49 073 196541304 
Buchbrunnenweg 12                 SE DECISION MADE: 01-NOV-19
Ulm  DE 89081                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CRP Vario
Sentinel CH, Spa                  510(k) NO: K192118(Special)
ATTN: Patricia  Dupe              PHONE NO : 32 023 4551496 
Via Robert Koch, 2                SE DECISION MADE: 08-NOV-19
Milano  IT 20152                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trevo Trak 21 Microcatheter
Stryker                           510(k) NO: K192122(Traditional)
ATTN: Rhoda  Santos               PHONE NO : 510 4132269 
47900 Bayside Parkway             SE DECISION MADE: 22-NOV-19
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories
US Medical Innovations, LLC       510(k) NO: K192124(Special)
ATTN: David  Hinds                PHONE NO : 301 2700147 
6930 Carroll Ave                  SE DECISION MADE: 21-NOV-19
Takoma Park MD  20912             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen
AtriCure, Inc                     510(k) NO: K192125(Special)
ATTN: Johnathon  McElwee          PHONE NO : 513 6444249 
7555 Innovation Way               SE DECISION MADE: 04-NOV-19
Mason OH  45040                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AMIStem-P Short Neck
Medacta International SA          510(k) NO: K192126(Special)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 22-NOV-19
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 7D Surgical System
7D Surgical Inc.                  510(k) NO: K192140(Traditional)
ATTN: Daniel  Ziskind             PHONE NO : 647 4840079 
60 Scarsdale Road, Unit 118       SE DECISION MADE: 05-NOV-19
Toronto  CA M3B 2R7               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AMICUS Separator System
Fresenius Kabi AG                 510(k) NO: K192150(Traditional)
ATTN: Aunica  Jones               PHONE NO : 49 6172 6860 
                                  SE DECISION MADE: 13-NOV-19
Bad Homburg  DE 61346             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Portux CAD/CAM Disc
New Stetic S.A.                   510(k) NO: K192153(Traditional)
ATTN: Juan David Jaramillo G.     PHONE NO : 57 4 5500000 
Carrera 53 No. 50 - 09            SE DECISION MADE: 07-NOV-19
Guarne - Antioquia  CO            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 6450 Ultrasound system
Esaote, S.p.A.                    510(k) NO: K192157(Traditional)
ATTN: Piet  DeJong                PHONE NO : 39 055 4229319 
Via E Melen 77                    SE DECISION MADE: 22-NOV-19
Genoa  IT 16152                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Idys ALIF ZP 3DTi
CLARIANCE, SAS                    510(k) NO: K192168(Traditional)
ATTN: Fadwa  Bahr                 PHONE NO : 33 0321 161215 
18 rue Robespierre                SE DECISION MADE: 04-NOV-19
Beaurains  FR 62217               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPY Portable Handheld Imaging (SPY-PHI) System
Novadaq Technologies ULC. (now a p510(k) NO: K192174(Traditional)
ATTN: Agatha  Szeliga             PHONE NO : 604 4227516 
8329 Eastlake Drive, Unit 101     SE DECISION MADE: 15-NOV-19
Burnaby  CA V5A 4W2               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PRECICE Plating System
NuVasive Specialized Orthopedics, 510(k) NO: K192181(Traditional)
ATTN: Madison  Heffron            PHONE NO : 949 5327868 
101 Enterprise, Suite 100         SE DECISION MADE: 07-NOV-19
Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph
Neurolign USA, LLC                510(k) NO: K192186(Traditional)
ATTN: Aura  Kullmann              PHONE NO : 412 9636649 
128 Gamma Drive                   SE DECISION MADE: 29-NOV-19
Pittsburgh PA  15238              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Conformis Hip System
Conformis, Inc.                   510(k) NO: K192198(Special)
ATTN: Paul  Smolenski             PHONE NO : 781 3459164 
600 Technology Park               SE DECISION MADE: 06-NOV-19
Billerica MA  01821               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clear21
World Class Technology Corporation510(k) NO: K192202(Traditional)
ATTN: Alan  Kozlowski             PHONE NO : 503 4728320 
1300 NE Alpha Dr.                 SE DECISION MADE: 12-NOV-19
McMinnville OR  97128             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal Lubricant, Sensuva Butter Rum Personal Lubricant, Sensuva Orange Creamsicle Personal Lubricant, Sensuva Salted Caramel Personal Lubricant,
Valencia Naturals Inc.            510(k) NO: K192204(Traditional)
ATTN: Louie  Goryoka              PHONE NO : 877 4707578 
9731 Topanga Canyon PL.           SE DECISION MADE: 19-NOV-19
Chatsworth CA  91311              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trevo NXT ProVue Retriever
Stryker                           510(k) NO: K192207(Traditional)
ATTN: Rhoda M Santos              PHONE NO : 510 4132269 
47900 Bayside Parkway             SE DECISION MADE: 22-NOV-19
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White)
Hartalega NGC Sdn. Bhd.           510(k) NO: K192232(Traditional)
ATTN: Kuan Mun Leong              PHONE NO : 603 6277 1733 
No. 1, Persiaran Tanjung Kawasan PSE DECISION MADE: 08-NOV-19
Sepang  MY 43900                  510(k) STATEMENT
                                                    

DEVICE: Fitmore Hip Stem
Zimmer GmbH                       510(k) NO: K192236(Special)
ATTN: Roberto  Tommasini          PHONE NO : 41 5885 48264 
Sulzer Allee 8                    SE DECISION MADE: 05-NOV-19
Winterthur  CH 8404               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AC3 Series Intra-Aortic Balloon Pump (IABP)
Arrow International, Teleflex     510(k) NO: K192238(Special)
ATTN: Deb  Fleetham               PHONE NO : 612 4033806 
16 Elizabeth Drive                SE DECISION MADE: 12-NOV-19
Chelmsford MA  01824              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Synergy Platform, Synergy, Infinity, VersaHD
Elekta Limited                    510(k) NO: K192242(Traditional)
ATTN: Irina  Proutski             PHONE NO : 44 1293 654201 
Linac House Fleming Way           SE DECISION MADE: 22-NOV-19
Crawley  GB rh10 9rr              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pentax Medical Video Duodenoscope ED34-i10T2
PENTAX of America, Inc.           510(k) NO: K192245(Traditional)
ATTN: William  Goeller            PHONE NO : 201 5712300 2318
3 Paragon Drive                   SE DECISION MADE: 15-NOV-19
Montvale NJ  07645-1782           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cortina™ [MAX] Lumbar Cage System
NeuroStructures, Inc.             510(k) NO: K192248(Special)
ATTN: Moti  Altarac               PHONE NO : 800 3526103 
199 Technology Drive, Suite 110   SE DECISION MADE: 25-NOV-19
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: everX Flow
GC America Inc.                   510(k) NO: K192260(Traditional)
ATTN: Mark  Heiss                 PHONE NO : 708 9263090 
3737 W. 127th Street              SE DECISION MADE: 22-NOV-19
Alsip IL  60803                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HIVOX Spopad EMS SP-911, SP-921
Hivox Biotek Inc.                 510(k) NO: K192264(Special)
ATTN: Marx  Lee                   PHONE NO : 886 2 85112668 
5F., No. 123, Xinde Rd. Sanchong DSE DECISION MADE: 08-NOV-19
New Taipei City  TW 24158         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: M. Blue Adjustable Shunt System
Aesculap, Inc.                    510(k) NO: K192266(Traditional)
ATTN: Kathy A Racosky             PHONE NO : 610 9849291 
3773 Corporate Parkway            SE DECISION MADE: 21-NOV-19
Center Valley PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TwinScan 808/755 Laser System
GME German Medical Engineering Gmb510(k) NO: K192269(Traditional)
ATTN: Stefan  Schulze             PHONE NO : 49 9131 93415910 
Grimmstrasse 23                   SE DECISION MADE: 19-NOV-19
Nuremberg  DE 90491               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LEva Pelvic Digital Health System
Renovia Inc.                      510(k) NO: K192270(Traditional)
ATTN: Gina  Prochilo-Cawston      PHONE NO : 866 7358424 1024
263 Summer St., 5th Floor         SE DECISION MADE: 22-NOV-19
Boston MA  02210                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Access PCT, Access PCT Calibrators
Beckman Coulter, Inc.             510(k) NO: K192271(Traditional)
ATTN: Jennifer  Bennett           PHONE NO : 952 3682040 
1000 Lake Hazeltine Drive         SE DECISION MADE: 26-NOV-19
Chaska MN  55318-1084             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)
UVision360 Inc.                   510(k) NO: K192278(Special)
ATTN: Allison London Brown        PHONE NO : 888 8559360 
158 Wind Chime Ct. Ste. 201       SE DECISION MADE: 01-NOV-19
Raleigh NC  27615                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior Scoliosis System, KANEDA SR Anterior Spinal System, M-2 Anterior Plate System, MOUNTAINEER Laminoplasty System, PROFILE Anterior Thoracolumbar Plate System, UNIVERSITY PLATE Anterior System, VIPER F2 Facet Fixation System
Medos International SARL          510(k) NO: K192281(Traditional)
ATTN: Sergio M. Cordeiro          PHONE NO : 508 9772640 
Chemin-Blanc 38                   SE DECISION MADE: 20-NOV-19
Le Locle  CH 2400                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
IRRAS USA, Ltd.                   510(k) NO: K192289(Traditional)
ATTN: Vinny  Podichetty           PHONE NO : 1 949 3563094 
11975 El Camino Real, Suite 304   SE DECISION MADE: 15-NOV-19
San Diego CA  92130               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable
Stryker                           510(k) NO: K192292(Traditional)
ATTN: April  Malmborg             PHONE NO : 408 7542473 
5900 Optical Court                SE DECISION MADE: 19-NOV-19
San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: APTUS Wrist Arthrodesis Plates
Medartis AG                       510(k) NO: K192297(Traditional)
ATTN: Andrea  Kiefer-Schweizer    PHONE NO : 41 61 6333434 
Hochbergerstrasse 60E             SE DECISION MADE: 08-NOV-19
Basel  CH CH-4057                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LZI Cotinine II Enzyme Immunoassay
Lin-Zhi International, Inc.       510(k) NO: K192299(Traditional)
ATTN: Bernice  Lin                PHONE NO : 408 9709030 
2945 Oakmead Village Court        SE DECISION MADE: 21-NOV-19
Santa Clara CA  95051             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HealthCXR
Zebra Medical Vision, Ltd.        510(k) NO: K192320(Traditional)
ATTN: Flair  Bar                  PHONE NO : 972 9882 7795 
Shefayim Commercial Center PO Box SE DECISION MADE: 26-NOV-19
Shefayim  IL 6099000              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PolyLock Small Bone Plating System
Fusion Orthopedics, LLC           510(k) NO: K192323(Traditional)
ATTN: Eli  Jacobson               PHONE NO : 800 4036876 
4135 S. Power Rd. Suite 110       SE DECISION MADE: 18-NOV-19
Mesa AZ  85212                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile
Synthes (USA) Products LLC        510(k) NO: K192327(Special)
ATTN: Thomas  Shea                PHONE NO : 610 7195679 
1301 Goshen Parkway               SE DECISION MADE: 07-NOV-19
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Blue Latex Examination Powder Free Gloves
JR Engineering & Medical Technolog510(k) NO: K192329(Abbreviated)
ATTN: Ganesan  Surbramaniam       PHONE NO : 603 6057 2081 
Lot 8 &10, Jalan Zurah 3 & Lot 1 &SE DECISION MADE: 25-NOV-19
Hulu Selangor  MY 44200           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LaseMD LEO Laser System
Lutronic Global                   510(k) NO: K192331(Traditional)
ATTN: James  Childs               PHONE NO : 
19 Fortune Drive                  SE DECISION MADE: 12-NOV-19
Billerica MA  01821               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Navigated Anterolateral Disc Prep Instruments
Medtronic Sofamor Danek USA, INC. 510(k) NO: K192336(Traditional)
ATTN: Parwinder  Singh            PHONE NO : 901 3963133 
1800 Pyramid Place                SE DECISION MADE: 22-NOV-19
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ST Internal Implant System
Megagen Implant Co. Ltd           510(k) NO: K192347(Traditional)
ATTN: You Jung Kim                PHONE NO : 82 53222 2991 
45, Secheon-ro 7-gil, Dasa-eup, DaSE DECISION MADE: 14-NOV-19
Daegu  KR 42921                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL)
Beckman Coulter, Inc.             510(k) NO: K192355(Traditional)
ATTN: Elaine  Duncan              PHONE NO : 916 3743279 
1584 Enterprise Blvd.             SE DECISION MADE: 14-NOV-19
West Sacramento CA  95691         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Shoulder Innovations Total Shoulder System
Shoulder Innovations Inc          510(k) NO: K192365(Special)
ATTN: Don  Running                PHONE NO : 574 2531133 
13827 Port Sheldon Street         SE DECISION MADE: 29-NOV-19
Holland MI  49424                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ion Endoluminal System
Intuitive Surgical, Inc.          510(k) NO: K192367(Traditional)
ATTN: Jennifer  Siu               PHONE NO : 408 5235372 
1266 Kifer Rd.                    SE DECISION MADE: 26-NOV-19
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack
DiaSorin Molecular LLC            510(k) NO: K192376(Traditional)
ATTN: Sharon  Young               PHONE NO : 562 2406500 
11331 Valley View Street          SE DECISION MADE: 26-NOV-19
Cypress CA  90630                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hi-Fatigue G Bone Cement
OSARTIS GmbH                      510(k) NO: K192379(Traditional)
ATTN: Volker  Stirnal             PHONE NO : 49 6071 9290 
Lagerstrasse 11-15                SE DECISION MADE: 27-NOV-19
Dieburg  DE 64807                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Streamline MIS Spinal Fixation System
Pioneer Surgical Technology, Inc. 510(k) NO: K192396(Traditional)
ATTN: Michael  Mach               PHONE NO : 386 4188888 7936
(DBA RTI Surgical Inc.) 375 River SE DECISION MADE: 26-NOV-19
Marquette MI  49855               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VK100 Percutaneous Vertebral Augmentation System
BONWRx Ltd                        510(k) NO: K192403(Traditional)
ATTN: Ralph W Charmichael         PHONE NO : 917 6670623 
924 Terminal Road                 SE DECISION MADE: 08-NOV-19
Lansing MI  48906                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARIX Cannulated Screw System
Jeil Medical Corporation          510(k) NO: K192417(Traditional)
ATTN: Sejin  Ryu                  PHONE NO : 82 2 8503583 
702,703,704,705,706,804,805,807,81SE DECISION MADE: 26-NOV-19
Seoul  KR 38378                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130
Shenzhen Bosidin Technology Co., L510(k) NO: K192432(Traditional)
ATTN: Wang  Jiaoyan               PHONE NO : 86 755 33883239 
Rm. 101 & 201, Bldg. 4, Haoer JiasSE DECISION MADE: 08-NOV-19
Shenzhen  CN 518000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rhythmia HDxTM Mapping System
Boston Scientific Corporation     510(k) NO: K192438(Traditional)
ATTN: Lee  Margolin               PHONE NO : 617 2183823 
125 Cambridgepark Drive           SE DECISION MADE: 27-NOV-19
Cambridge MA  02140               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FDR SE Lite
Fujifilm Corporation              510(k) NO: K192440(Traditional)
ATTN: Randy  Vader                PHONE NO : 360 3566821 
798 Miyanodai Kaisei-Machi        SE DECISION MADE: 01-NOV-19
Ashigarakami-Gun Kanagawa  JP 258-510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter
Hangzhou Bever Medical Devices Co.510(k) NO: K192468(Traditional)
ATTN: Allyson  Zhou               PHONE NO : 86 571 88616630 
Building 2, No. 1-1, Houmuqiao, YoSE DECISION MADE: 27-NOV-19
Hangzhou  CN 311121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nox Sleep System
Nox Medical                       510(k) NO: K192469(Traditional)
ATTN: Kolburn E Ottosdottir       PHONE NO : 354 5707170 
Katrinartuni 2                    SE DECISION MADE: 13-NOV-19
Reykjavik  IS 105                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Torpedo Gelatin Foam
Biosphere Medical, S.A.           510(k) NO: K192480(Traditional)
ATTN: Alix  Fonlladosa            PHONE NO : 33 1 48172529 
Parc des Nations – Paris Nord 2, 3SE DECISION MADE: 21-NOV-19
Roissy-en-France  FR 95700        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medsynapse Ris Pacs & Medsynapse VNA
Medsynaptic Private Ltd           510(k) NO: K192508(Traditional)
ATTN: Ashish  Dhawad              PHONE NO : 91 20256 50411 
5th Floor, Mantri Galleria, Off S.SE DECISION MADE: 22-NOV-19
Shivaji Nagar  IN 411016          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Multi-modality workstation
Beijing Superlaser Technology Co.,510(k) NO: K192519(Traditional)
ATTN: Shi  Shuang                 PHONE NO : 86 10 81284899 806
No.2 Zhongfu Street, Economic and SE DECISION MADE: 27-NOV-19
Xihongmen Town, Daxing District, B510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dolphin Medical Imaging USB Ultrasound System
Dolphin Medical Imaging, LLC      510(k) NO: K192573(Third Party - Traditional)
ATTN: Brian S. Heaney             PHONE NO : 919 4507668 
161 Dawn River Way                SE DECISION MADE: 19-NOV-19
Folsom CA  95630                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: NuVasive CoRoent Small Interlock System
NuVasive, Incorporated            510(k) NO: K192582(Traditional)
ATTN: Jessica  LeBlanc            PHONE NO : 858 9093302 
7475 Lusk Blvd.                   SE DECISION MADE: 13-NOV-19
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Axis Plating System
Extremity Medical, LLC.           510(k) NO: K192592(Traditional)
ATTN: Brian  Smekal               PHONE NO : 973 5888980 
300 Interpace Parkway, Suite 410  SE DECISION MADE: 21-NOV-19
Parsippany NJ  07054              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spes Medica Subdermal Needle Electrodes
Spes Medica S.r.l.                510(k) NO: K192603(Traditional)
ATTN: Giorgio  Facco              PHONE NO : 39 0828 614191 
Via Europa - zona industriale     SE DECISION MADE: 22-NOV-19
Battipaglia (SA)  IT 84091        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PG Pro Microcatheter
MicroVention, Inc., A Terumo Group510(k) NO: K192625(Traditional)
ATTN: Ganesh  Balachandar         PHONE NO : 1 714 2478000 8201
35 Enterprise                     SE DECISION MADE: 21-NOV-19
Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless
Canon, Inc.                       510(k) NO: K192632(Special)
ATTN: Yamazaki  Tatsuya           PHONE NO : 81 3 37582111 
30-2 Shimomaruko, 3-Chrome, Ohta-KSE DECISION MADE: 07-NOV-19
Tokyo  JP 146-8501                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dannik Laparoscopic Suction Irrigation System
Dannik                            510(k) NO: K192643(Traditional)
ATTN: Olga  Haberlad              PHONE NO : 407 7451698 
941 W Morse Blvd. Suite 100       SE DECISION MADE: 19-NOV-19
Winter Park FL  32789             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LATERA Absorbable Nasal Implant System
Entellus Medical, Inc. (Aka Stryke510(k) NO: K192661(Special)
ATTN: Karen E. Peterson           PHONE NO : 763 4637076 
3600 Holly Lane North, Suite 40   SE DECISION MADE: 10-NOV-19
Plymouth MN  55447                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FUJIFILM Endoscope Model EC-760Z-V/L
FUJIFILM Corporation              510(k) NO: K192664(Traditional)
ATTN: Randy  Vader                PHONE NO : 360 3566821 
798 Miyanodai Kaisei-Machi        SE DECISION MADE: 20-NOV-19
Ashigarakami-Gun  JP 258-8538     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: uPMR 790
Shanghai United Imaging Healthcare510(k) NO: K192672(Traditional)
ATTN: Xin  Gao                    PHONE NO : 86 021670 768885386 
No. 2258 Chengbei Rd,             SE DECISION MADE: 20-NOV-19
Shanghai  CN 201807               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VariAx Foot
Stryker GmbH                      510(k) NO: K192675(Traditional)
ATTN: Jemin  Dedania              PHONE NO : 201 8316461 
325 Corporate Drive               SE DECISION MADE: 22-NOV-19
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml
Thermo Fisher Scientific          510(k) NO: K192729(Traditional)
ATTN: Cynthia  Knapp              PHONE NO : 1 800 8718909 
One Thermo Fisher Way             SE DECISION MADE: 06-NOV-19
Oakwood Village OH  44146         510(k) STATEMENT
                                                    

DEVICE: ETEST Delafloxacin (DFX) (0.002-32 µg/mL)
BioMerieux SA                     510(k) NO: K192738(Traditional)
ATTN: Sophie  Quiblier            PHONE NO : 33 047887 7571 
376, Chemin de L'Orme             SE DECISION MADE: 26-NOV-19
Marcy L'Etoile  FR 69280          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DePuy Synthes Trauma Screws
Synthes (USA) Products LLC / DePuy510(k) NO: K192745(Traditional)
ATTN: Keith  Knapp                PHONE NO : 610 7195000 
1301 Goshen Parkway               SE DECISION MADE: 26-NOV-19
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeuroOne Cortical Electrode
NeuroOne, Inc.                    510(k) NO: K192764(Traditional)
ATTN: Debra  Kridner              PHONE NO : 
10901 Red Circle Dr., Suite 150   SE DECISION MADE: 26-NOV-19
Minnetonka MN  55343              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Impella CP Introducer
Abiomed, Inc.                     510(k) NO: K192769(Traditional)
ATTN: Robert  Stewart             PHONE NO : 978 6461400 
22 Cherry Hill Drive              SE DECISION MADE: 18-NOV-19
Danvers MA  01923                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADVIA Centaur CA 15-3 assay
Siemens Healthcare Diagnostics, In510(k) NO: K192777(Traditional)
ATTN: Anoop  Joy                  PHONE NO : 914 5242273 
511 Benedict Avenue               SE DECISION MADE: 22-NOV-19
Tarrytown NY  10591               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ASAHI CROSSWALK Peripheral Support Catheter
Asahi Intecc Co., Ltd.            510(k) NO: K192782(Traditional)
ATTN: Yasuyuki  Kawuhara          PHONE NO : 81 561 561859 
3-100 Akatsuki-cho                SE DECISION MADE: 29-NOV-19
Seto  JP 489-0071                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADVIA Centaur Cortisol (COR)
Siemens Healthcare Diagnostics, In510(k) NO: K192788(Traditional)
ATTN: Ian  Thompson               PHONE NO : 914 5242296 
511 Benedict Avenue               SE DECISION MADE: 25-NOV-19
Tarrytown NY  10591               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diagnostic Ultrasound System
Edan Instruments, Inc.            510(k) NO: K192791(Traditional)
ATTN: Stella  Guo                 PHONE NO : 86 755 26858736 
#15 Jinhui Road, Jinsha Community,SE DECISION MADE: 27-NOV-19
Shenzhen  CN 518122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TranS1 AxiaLIF Plus System
TranS1                            510(k) NO: K192792(Traditional)
ATTN: Kristen  Allen              PHONE NO : 888 5261879 
3804 Park Avenue                  SE DECISION MADE: 20-NOV-19
Wilmington NC  28403              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OEC Elite
GE OEC Medical Systems, Inc.      510(k) NO: K192819(Special)
ATTN: Kenny M Bello               PHONE NO : 801 2013986 
384 N Wright Brothers Drive       SE DECISION MADE: 08-NOV-19
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Parcus Knotless AP Suture Anchors
Parcus Medical, LLC               510(k) NO: K192824(Special)
ATTN: Paul  Vagts                 PHONE NO : 941 7557965 
6423 Parkland Dr                  SE DECISION MADE: 02-NOV-19
Sarasota FL  34243                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High
Eurotrol B.V.                     510(k) NO: K192842(Traditional)
ATTN: Elisanne  Biemans           PHONE NO : 003 131 8695777 
Keplerlaan 20                     SE DECISION MADE: 15-NOV-19
EDE  NL 6716BS                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream
Innovita (Tangshan) Biological Tec510(k) NO: K192843(Traditional)
ATTN: Leo  Lee                    PHONE NO : 86 315 7612828 
No. 699 Juxin Street, High-tech InSE DECISION MADE: 22-NOV-19
Qian'an  CN 064400                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: A1AT Genotyping Test
Progenika Biopharma S.A., A Grifol510(k) NO: K192858(Special)
ATTN: Diego  Tejedor              PHONE NO : 34 944 064525 
Ibaizabal bidea, Edificio 504, ParSE DECISION MADE: 05-NOV-19
Derio  ES 48160                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: B. anthracis Real-time PCR Assay
Centers for Disease Control and Pr510(k) NO: K192871(Special)
ATTN: Yon  Yu                     PHONE NO : 404 6393046 
1600 Clifton Road NE, MS: H24-11  SE DECISION MADE: 07-NOV-19
Atlanta GA  30329                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Senhance Surgical System
TransEnterix, Inc.                510(k) NO: K192877(Special)
ATTN: Kaitlyn  Alexander          PHONE NO : 1 919 7658400 8505
635 Davis Drive, Suite 300        SE DECISION MADE: 22-NOV-19
Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Laparoscope Lens Shield Device (LENS)
Medeon Biodesign, Inc             510(k) NO: K192891(Special)
ATTN: Tsung-Yu  Hsieh             PHONE NO : 886 228 16686 130
7F, 116 Hougang St.,              SE DECISION MADE: 07-NOV-19
Taipei  TW 11170                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Advocate PTA Catheter
Merit Medical Systems Inc.        510(k) NO: K192907(Traditional)
ATTN: Mark  Mullaney              PHONE NO : 353 91 703700 3061
Parkmore Business Park West       SE DECISION MADE: 26-NOV-19
Galway  IE N-A                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes
Wilson-Cook Medical, Inc          510(k) NO: K192908(Special)
ATTN: Tiffanny A. Thomas          PHONE NO : 336 7440157 396680
4900 Bethania Station Road        SE DECISION MADE: 14-NOV-19
Winston-Salem NC  27105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Brainlab Compatible K2M Navigation Instruments
K2M, Inc.                         510(k) NO: K192911(Special)
ATTN: Oonagh  Lahiff              PHONE NO : 
600 Hope Parkway SE               SE DECISION MADE: 14-NOV-19
Leesburg VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GMA 2.0 Pedicle Screw System
Grafton Medical Alliance          510(k) NO: K192915(Special)
ATTN: James  Henry                PHONE NO : 630 5683061 
7416 Country Line Road Suite E    SE DECISION MADE: 13-NOV-19
Burr Ridge IL  60527              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pinnacle Duofix HA Acetabular Cup Prosthesis
DePuy Orthopaedics, Inc.          510(k) NO: K192919(Special)
ATTN: Kathy  Harris               PHONE NO : 508 9776448 
700 Orthopaedic Dr.               SE DECISION MADE: 26-NOV-19
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FDR D-EVO III flat panel detector system
FUJIFILM Corporation              510(k) NO: K192932(Special)
ATTN: Randy  Vader                PHONE NO : 360 3566821 
798 Miyanodai Kaisei-Machi        SE DECISION MADE: 12-NOV-19
Ashigarakami-Gun  JP 258-8538     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CAPERE Thrombectomy System
Vascular Medcure, Inc.            510(k) NO: K192935(Special)
ATTN: Jeffrey P DuMontelle        PHONE NO : 949 3784742 
1500 S. Sunkist St. - Suite H     SE DECISION MADE: 15-NOV-19
Anaheim CA  92806                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Soltus 500
Sedecal., SA.                     510(k) NO: K192936(Special)
ATTN: Ma Luisa  Gomez de Aguero   PHONE NO : 34 91 6280544 
C/ Pelaya, 9-13 Pol. Ind. Rio de JSE DECISION MADE: 15-NOV-19
Algete  ES 28110                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M Comply Hydrogen Peroxide Chemical Indicator
3M Company                        510(k) NO: K192937(Special)
ATTN: Mary  Fretland              PHONE NO : 651 7372296 
3M Center, Building 275-5W-06     SE DECISION MADE: 16-NOV-19
St. Paul MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CoolTone
Zimmer MedizinSysteme GmbH        510(k) NO: K192940(Special)
ATTN: Ute  Hauss                  PHONE NO : 49 731 9761216 
Junkerstrasse 9                   SE DECISION MADE: 15-NOV-19
Neu-Ulm  DE 89231                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application
7D Surgical Inc.                  510(k) NO: K192945(Special)
ATTN: Daniel  Zisind              PHONE NO : 647 4840079 
60 Scarsdale Road, Unit 118       SE DECISION MADE: 27-NOV-19
Toronto  CA M3B 2R7               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DePuy Corail AMT Hip Prosthesis
DePuy Orthopaedics, Inc.          510(k) NO: K192946(Special)
ATTN: Kathy  Harris               PHONE NO : 508 9776448 
700 Orthopaedic Drive             SE DECISION MADE: 26-NOV-19
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G
Bard Peripheral Vascular, Inc.    510(k) NO: K192948(Special)
ATTN: Meghan  McKelvey            PHONE NO : 480 3506153 
1625 West 3rd Street              SE DECISION MADE: 07-NOV-19
Tempe AZ  85281                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Penumbra LP Coil System
Penumbra, Inc.                    510(k) NO: K192955(Special)
ATTN: Anush  Puvvada              PHONE NO : 510 4405568 
One Penumbra Place                SE DECISION MADE: 20-NOV-19
Alameda CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Parcus Synd-EZ SS
Parcus Medical, LLC               510(k) NO: K192964(Special)
ATTN: Paul  Vagts                 PHONE NO : 941 7557965 
6423 Parkland Dr                  SE DECISION MADE: 22-NOV-19
Sarasota FL  34243                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IDENTIFY
Varian Medical Systems, Inc.      510(k) NO: K192968(Special)
ATTN: Peter J Coronado            PHONE NO : 650 4246320 
3100 Hansen Way                   SE DECISION MADE: 12-NOV-19
Palo Alto CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Suglue 3
3M Deutschland GMBH               510(k) NO: K192992(Third Party - Traditional)
ATTN: Desi W. Soegiarto           PHONE NO : 49 8152 7001169 
ESPE Platz, Seefeld               SE DECISION MADE: 05-NOV-19
Bavaria  DE 82229                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool
Biotronik, Inc                    510(k) NO: K192996(Special)
ATTN: Jon  Brumbaugh              PHONE NO : 888 3450374 
6024 Jean Road                    SE DECISION MADE: 21-NOV-19
Lake Oswego OR  97035             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP
DRTECH Corporation                510(k) NO: K193017(Special)
ATTN: Shin  Dongwook              PHONE NO : 82 31 7797783 
Suite No.1, 1 Floor / Suite No.2, SE DECISION MADE: 22-NOV-19
Jungwon-gu, Seongam-si  KR 13216  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EXPD 4343P, EXPD 3643P
DRTECH Corporation                510(k) NO: K193031(Special)
ATTN: Dongwook  Shin              PHONE NO : 82 31779 7783 
Suite No.1, 1 Floor / Suite No.2, SE DECISION MADE: 22-NOV-19
Jungwon-gu, Seongam-si  KR 13216  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AXS Infinity LS Plus Long Sheath
Stryker Neurovascular             510(k) NO: K193034(Special)
ATTN: Shivani H Patel             PHONE NO : 510 4132772 
47900 Bayside Parkway             SE DECISION MADE: 29-NOV-19
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: C2 CryoBalloon EndoGrip
PENTAX Medical, A Division of PENT510(k) NO: K193036(Special)
ATTN: Gurvinder Singh Nanda       PHONE NO : 650 3168601 
303 Convention Way, Suite 1       SE DECISION MADE: 22-NOV-19
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Resorbable Mesh Device
SeaSpine Orthopedics Corporation  510(k) NO: K193040(Special)
ATTN: Caryn  Sailor               PHONE NO : 949 8557174 
2 Goodyear                        SE DECISION MADE: 30-NOV-19
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hemochron Signature Elite
Accriva Diagnostics, Inc.         510(k) NO: K193041(Special)
ATTN: Brian  James                PHONE NO : 858 2632350 
6260 Sequence Drive               SE DECISION MADE: 22-NOV-19
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA

        TOTAL 510(k)s THIS PERIOD   258                                     
        TOTAL WITH SUMMARIES        244                                     
        TOTAL WITH STATEMENTS        14
 
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