510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD May 2021
DEVICE: Neuro-IOM system with Neuro-IOM.NET software
Neurosoft Ltd 510(k) NO: K190703(Traditional)
ATTN: Eugene Polezhaev PHONE NO : 7 4932 240434
5, Voronin str. SE DECISION MADE: 22-MAY-21
Ivanovo RU 153032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Solax Electric Scooter (Models: S204311M, S204161, S204143)
Dongguan Prestige Sporting Goods C510(k) NO: K190737(Traditional)
ATTN: Zhang Zhao PHONE NO : 86 137 63128800
3rd Ind. District, Qiaotou Area, HSE DECISION MADE: 10-MAY-21
Dongguan CN 523950 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Yumizen C1200 Creatinine PAP
Horiba ABX SAS 510(k) NO: K193649(Traditional)
ATTN: Caroline Ferrer PHONE NO : 33 467 0144516
Parc Euromedecine SE DECISION MADE: 10-MAY-21
Montpellier Cedex 4 FR 341184 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)
Prevest Denpro Limited 510(k) NO: K200555(Traditional)
ATTN: Atul Modi PHONE NO : 941 9194280
Export Promotion Industrial Park SE DECISION MADE: 13-MAY-21
Bari Brahmana IN 181133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BoneTrust Mini Implant System
Medical Instinct Deutschland GmbH 510(k) NO: K200573(Abbreviated)
ATTN: Jan Worlitz PHONE NO : 49 5593 95196
Graseweg 24 SE DECISION MADE: 14-MAY-21
Bovenden DE 37120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters
Waldemar Link GmbH & Co. KG 510(k) NO: K200607(Traditional)
ATTN: Stafanie Fuchs PHONE NO :
Ostsraße 4-10 SE DECISION MADE: 28-MAY-21
Norderstedt DE 22844 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZedView
Lexi Co., Ltd. 510(k) NO: K200704(Traditional)
ATTN: Takao Kusunoki PHONE NO : 81 03 53944833
2-11-1 Sugamo, Toshima-Ku SE DECISION MADE: 27-MAY-21
Tokyo JP 170-0002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Genius / Genuin Total Knee System
Biorad Medisys PVT LTD 510(k) NO: K200765(Traditional)
ATTN: Sudhakar Saxena PHONE NO :
Survey No 48/3 & 48/7, Pashan Sus SE DECISION MADE: 05-MAY-21
Pune IN 411021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rebellion, Phantom Multi-Bite Kerrison Rongeur
Morpheus AG 510(k) NO: K200768(Traditional)
ATTN: Timo Rack PHONE NO : 49 7461703820
Bahnhofstraße 20 SE DECISION MADE: 04-MAY-21
Spaichingen DE 78549 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProntoPump Sterile Tube Set
IPAX, Inc 510(k) NO: K200893(Traditional)
ATTN: Jeff Baldwin PHONE NO : 303 9752444
2700 S Raritan St SE DECISION MADE: 04-MAY-21
Englewood CO 80110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electric Breast Pump
Guangdong Horigen Mother & Baby Pr510(k) NO: K201152(Traditional)
ATTN: Jun Deng PHONE NO : 086 0754 83613668
Block A&B&C, NCBC Industrial Park,SE DECISION MADE: 04-MAY-21
Shantou CN 515100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Impla-NX (Model: ISE-270M)
MICRO-NX Co., Ltd. 510(k) NO: K201192(Traditional)
ATTN: Jong-Kun Lee PHONE NO : 82 53 6110071
37, Dalseong2chadong 3-ro, Guji-mySE DECISION MADE: 21-MAY-21
Daegu KR 711-891 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Manual Wheelchair, Model A011
Ningbo Shenyu Medical Equipment Co510(k) NO: K201461(Traditional)
ATTN: Zhou Yuefeng PHONE NO : 86 574 62517777
No. 1318 West of Tanjialing Road SE DECISION MADE: 21-MAY-21
Yuyao CN 315408 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single-use medical poly (vinyl chloride) examination glove
Anhui Bytech Medical Supplies Co.,510(k) NO: K201504(Traditional)
ATTN: Cheng Wang PHONE NO : 86 0557 6602888
LingBi Economic Development Zone(NSE DECISION MADE: 10-MAY-21
SuZhou CN 234200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUVIS-spine
Curexo, Inc. 510(k) NO: K201569(Traditional)
ATTN: Jungeun Park PHONE NO : 82 31788 7935
577, Gangnam-Daero, Seocho-Gu SE DECISION MADE: 19-MAY-21
Seoul KR 06530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Latex Powder Free Examination Gloves (Non-sterile)
PT. Universal Gloves 510(k) NO: K201576(Traditional)
ATTN: Sutopo Sutopo PHONE NO : 62 61 7883055
JL. Pertahanan No.17 Patumbak SE DECISION MADE: 19-MAY-21
Medan ID 20361 510(k) STATEMENT
DEVICE: Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads
Beijing Biosis Healing Biological 510(k) NO: K201639(Traditional)
ATTN: Ting Jiang PHONE NO : 86 10 61252660
Valley No.1 Bio-medicine Industry SE DECISION MADE: 27-MAY-21
Beijing CN 102600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A-Link Z
Acuity Surgical Devices, LLC 510(k) NO: K201671(Traditional)
ATTN: Bryan Cowan PHONE NO : 1 844 2284890
8710 N Royal Lane SE DECISION MADE: 04-MAY-21
Irving TX 75063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Umbilical Vessels Catheter
Haolang Medical USA Corporation 510(k) NO: K201697(Traditional)
ATTN: Lisa Xu PHONE NO : 1 425 5036325
1100 Bellevue Way NE 8A-533 SE DECISION MADE: 06-MAY-21
Bellevue WA 98004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KDL Angiography Catheter
Shanghai Kindly Medical Instrument510(k) NO: K201929(Traditional)
ATTN: Xu Jianhai PHONE NO : 86 21 59140056 8870
No. 925 Jinyuan yi Road SE DECISION MADE: 14-MAY-21
Shanghai CN 201803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL
Gilero, LLC 510(k) NO: K201936(Third Party - Traditional)
ATTN: Kristin Benokraitis PHONE NO : 919 5995599
635 Davis Drive, Suite 100 SE DECISION MADE: 06-MAY-21
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series
Nihon Kohden Corporation 510(k) NO: K201949(Traditional)
ATTN: Sandra Gadeyne PHONE NO : 949 2687708
1-31-4 Nishiochiai, Shinjuki-Ku SE DECISION MADE: 02-MAY-21
Tokyo JP 161-8560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Talent-Pro Electromagnetic Stimulator
Remed Co., Ltd 510(k) NO: K202031(Traditional)
ATTN: Yoonsoo Nam PHONE NO : 82 42 9345580
#301-#303 Migun Techno World II, 1SE DECISION MADE: 06-MAY-21
Daejeon KR 34025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cardiac Trigger Monitor
Ivy Biomedical Systems, Inc. 510(k) NO: K202138(Traditional)
ATTN: Alejandra Aceves PHONE NO : 203 4814183
11 Business Park Drive SE DECISION MADE: 14-MAY-21
Branford CT 06405 510(k) STATEMENT
DEVICE: Bigfoot Unity Diabetes Management System
Bigfoot Biomedical, Inc. 510(k) NO: K202145(Traditional)
ATTN: Kate Lee PHONE NO : 650 2691992
1820 McCarthy Blvd SE DECISION MADE: 07-MAY-21
Milpitas CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HD Mediastinoscope
Karl Storz Endoscopy America, Inc.510(k) NO: K202272(Traditional)
ATTN: Winkie Wong PHONE NO : 424 2188379
2151 E. Grand Ave SE DECISION MADE: 11-MAY-21
El Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultrasonic Surgical Aspirator System
SMTP Technology Co., Ltd 510(k) NO: K202299(Traditional)
ATTN: Songtao Zhan PHONE NO : 0086 0512 82508100
1F&4F, Building A, Emerging IndustSE DECISION MADE: 21-MAY-21
Zhangjiagang CN 215634 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zio Monitor
iRhythm Technologies, Inc. 510(k) NO: K202359(Traditional)
ATTN: Rich Laguna PHONE NO : 415 6325700
699 8th Street SE DECISION MADE: 21-MAY-21
San Francisco CA 94103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL)
Beckman Coulter, Inc. 510(k) NO: K202423(Special)
ATTN: Elaine Duncan PHONE NO : 916 3743279
1584 Enterprise Blvd. SE DECISION MADE: 18-MAY-21
West Sacramento CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kerecis Reconstruct
Kerecis Limited 510(k) NO: K202430(Traditional)
ATTN: Gudmundur Fertram SigurjonssPHONE NO : 3 54 5622601
Eyrargata 2 – PO Box 151 SE DECISION MADE: 02-MAY-21
Isafjordur IS 400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BonOs Inject, Pedicle screw kits, Cement pusher
Osartis GmbH 510(k) NO: K202458(Traditional)
ATTN: Volker Stirnal PHONE NO : 49 6071 9290
Auf der Beune 101 SE DECISION MADE: 18-MAY-21
Munster DE 64839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PtoleMedic System
Lento Medical Innovation, Inc. 510(k) NO: K202521(Traditional)
ATTN: David W. Schlerf PHONE NO : 925 7680247
15110 Northwest Freeway, Suite 150SE DECISION MADE: 04-MAY-21
Houston TX 77040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zio ECG Utilization Software (ZEUS) System
iRhythm Technologies, Inc. 510(k) NO: K202527(Traditional)
ATTN: Gabrielle Logan PHONE NO : 4404 7904538
699 8th Street SE DECISION MADE: 21-MAY-21
San Francisco CA 94103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KardiFlex NC Coronary Dilatation Catheter
Medcaptain Life Science Co., Ltd. 510(k) NO: K202578(Traditional)
ATTN: David Xia PHONE NO : 86 755 28380626
601, Building C, Jinweiyuan IndustSE DECISION MADE: 06-MAY-21
Shenzhen CN 518118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Turbett Instrument Pod
Turbett Surgical Inc. 510(k) NO: K202593(Traditional)
ATTN: Rob Turbett PHONE NO : 587 7550133
125 Tech Park Drive SE DECISION MADE: 19-MAY-21
Rochester NY 14625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Level 3
3A Medical Products Co., Ltd 510(k) NO: K202598(Traditional)
ATTN: Slinda Ma PHONE NO : 86 564 3611700
Yu An Industrial Park 230001 SE DECISION MADE: 06-MAY-21
Liu An CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Personal Lubricant Jelly
Nantong Health & Beyond Hygienic P510(k) NO: K202667(Traditional)
ATTN: Michael Zhu PHONE NO : 86 512 57108262
No. 118, Yuxian road, North Town SSE DECISION MADE: 18-MAY-21
Rugao CN 226575 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask
United Sewing Automation Inc. 510(k) NO: K202697(Abbreviated)
ATTN: Benjamin Webb PHONE NO : 336 7102404
1772 N. Andy Griffith Parkway SE DECISION MADE: 13-MAY-21
Mount Airy NC 27030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges
Ningbo Verykind Medical Device Co.510(k) NO: K202709(Traditional)
ATTN: Hong Pengfei PHONE NO : 86 574 87910279
#100 Jinghua Road, Hi-tech industrSE DECISION MADE: 18-MAY-21
Ningbo CN 315040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ignite Anatomic Shoulder System
Ignite Orthopedics LLC 510(k) NO: K202716(Traditional)
ATTN: Matt Purdy PHONE NO : 612 2145361
700 Park Avenue Suite F SE DECISION MADE: 20-MAY-21
Winona Lake IN 46590 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Klarity Bolus
Klarity Medical & Equipment (GZ) C510(k) NO: K202747(Traditional)
ATTN: Lucy Li PHONE NO : 86 20 82226380
No. 14 3rd St., Shawan GETDD SE DECISION MADE: 14-MAY-21
Guangzhou CN 510730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs
Careplus (M) SDN BHD 510(k) NO: K202765(Traditional)
ATTN: Lim Kwee Shyan PHONE NO : 60 66 772781
Lot 120 & 121, Jalan Senawang 3, SSE DECISION MADE: 27-MAY-21
Seremban MY 70450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cercare Medical Neurosuite
Cercare Medical ApS 510(k) NO: K202793(Traditional)
ATTN: Mikkel Bo Hansen PHONE NO : 45 22 890125
10 Inge Lehmanns Gade SE DECISION MADE: 17-MAY-21
Aarhus DK DK-8000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Implacil Implant System
Implacil de Bortoli Material Odont510(k) NO: K202832(Traditional)
ATTN: Thiago Toni PHONE NO : 55 11 33425100
Rua Vicente de Carvalho 178-182 SE DECISION MADE: 26-MAY-21
Sao Paulo BR 01521020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax V Kone (VK) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A)
Valley Contax, Inc. 510(k) NO: K202860(Traditional)
ATTN: Josh Adams PHONE NO : 800 5478815
200 S Mill St. SE DECISION MADE: 11-MAY-21
Springfield OR 97477 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gx-IVF, Gx-TL, Gx-MOPS PLUS
Vitrolife Sweden AB 510(k) NO: K202862(Traditional)
ATTN: Sarah Hood Hagberg PHONE NO : 46 31 7218000
Gustaf Werners gata 2 SE DECISION MADE: 14-MAY-21
Vastra Frolunda SE 42132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENS & EMS Device
SHenzhen Jianfeng Electronic Techn510(k) NO: K202866(Traditional)
ATTN: Feng Wen PHONE NO : 86 755 33858361
#902,903 Jialingyu Industry BuildiSE DECISION MADE: 19-MAY-21
Baoan District, Shenzhen City CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Procedure Mask, Surgical Mask
Kenpax International Limited 510(k) NO: K202899(Traditional)
ATTN: Solomon Chen PHONE NO : 852 909 5915168
Flat 5, 5/F, Wing On Plaza, 62 ModSE DECISION MADE: 20-MAY-21
Hong Kong CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATS 5000 Automatic Tourniquet Instrument
McEwen and Associates Consulting L510(k) NO: K202919(Traditional)
ATTN: Julie Kerr PHONE NO : 1 604 7420600
207-1099 West 8th Avenue SE DECISION MADE: 20-MAY-21
Vancouver CA V6H 1C3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Uro-G Cystoscope
UroViu Corporation 510(k) NO: K202921(Traditional)
ATTN: Thomas Lawson PHONE NO : 510 2061794
5337 - 14th Place SE SE DECISION MADE: 04-MAY-21
Bellevue WA 98006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LinkSymphoKnee System
Waldemar Link GmbH & Co. KG 510(k) NO: K202924(Traditional)
ATTN: Stefanie Fuchs PHONE NO : 49 40 53995530
Oststrasse 4-10 SE DECISION MADE: 13-MAY-21
Norderstedt DE 22844 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABT12 multi-purpose solution
Bausch & Lomb Incorporated 510(k) NO: K202932(Traditional)
ATTN: Melissa Thomas PHONE NO : 585 3386045
1400 North Goodman Street SE DECISION MADE: 28-MAY-21
Rochester NY 14609 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Contour Light CL-100
Contour Research, LLC 510(k) NO: K202955(Traditional)
ATTN: Doug Dreier PHONE NO : 855 9326686
200 S Virginia St #8 SE DECISION MADE: 19-MAY-21
Reno NV 89501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRPx Locking Distal Radius Plate System
Orthopaedic Implant Company 510(k) NO: K202971(Traditional)
ATTN: Douglas Fulton PHONE NO : 775 6368281
770 Smithridge Dr. #400 SE DECISION MADE: 06-MAY-21
Reno NV 89502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HANAROSTENT Benefit Biliary (NNN)
M.I.Tech Co., Ltd. 510(k) NO: K202973(Traditional)
ATTN: Inae Kim PHONE NO : 82 70 43047450
174, Habuk 2-gil, Jinwi-myeon SE DECISION MADE: 11-MAY-21
Pyeongtaek-si KR 17706 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)
Central Medicare Sdn Bhd 510(k) NO: K203036(Traditional)
ATTN: Fatin Nor Irdina Bt Ahmad FaPHONE NO : 60 562 90000
PT 2609-2620, Batu 8, Jalan ChangkSE DECISION MADE: 07-MAY-21
Teluk Intan MY 36000 510(k) STATEMENT
DEVICE: Medline Vacu-line Suction Aspirator
Medline Industries, Inc. 510(k) NO: K203135(Traditional)
ATTN: Kelsey Closen PHONE NO : 847 6434071
Three Lake Drive SE DECISION MADE: 04-MAY-21
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MicroPen EVO
Eclipse MedCorp, LLC 510(k) NO: K203144(Traditional)
ATTN: Julie Summerville PHONE NO : 972 3802911 2405
5916 Stone Creek Drive SE DECISION MADE: 25-MAY-21
The Colony TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)
Bolder Surgical, LLC 510(k) NO: K203183(Traditional)
ATTN: Nicholas Wong PHONE NO : 720 2877130
331 S. 104th Street, Suite 200 SE DECISION MADE: 06-MAY-21
Louisville CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NaviCam Xpress Stomach System
AnX Robotica Corp 510(k) NO: K203192(Traditional)
ATTN: Shoshana (Shosh) Friedman PHONE NO : 704 4308695
1047 Serpentine Lane SE DECISION MADE: 04-MAY-21
Pleasanton CA 94566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Peak flow meter
Shanghai Sonmol Medical Equipment 510(k) NO: K203196(Traditional)
ATTN: Li Yong Xu PHONE NO : 86 159 27686299
Room 116-118, Building 21,No.500 JSE DECISION MADE: 26-MAY-21
Shanghai CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CaP Spheres Pellet Pack
Zimmer Biomet Spine Inc. 510(k) NO: K203218(Traditional)
ATTN: Leo Su PHONE NO : 303 2294374
10225 Westmoor Drive SE DECISION MADE: 04-MAY-21
Westminster CO 80021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MM
Richard Wolf Medical Instruments C510(k) NO: K203226(Traditional)
ATTN: Michael Loiterman PHONE NO : 847 9131113
353 Corporate Woods Parkway SE DECISION MADE: 14-MAY-21
Vernon Hills IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DART-FIRE EDGE Cannulated Screw System
Wright Medical 510(k) NO: K203228(Traditional)
ATTN: Michael Mullins PHONE NO : 901 8674142
1023 Cherry Road SE DECISION MADE: 11-MAY-21
Memphis TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TECHFIT Patient-Specific Maxillofacial System
Industrias Medicas Sampedro S.A.S.510(k) NO: K203282(Traditional)
ATTN: Leidy Johanna Toro Gonzalez PHONE NO : 574 322 3375 200
Carrera 47 N 100 Sur 40 Centro IndSE DECISION MADE: 19-MAY-21
La Estrella CO 055468 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ChoiceSpine Blackhawk Ti Cervical Spacer System
ChoiceSpine, LLC 510(k) NO: K203311(Traditional)
ATTN: Kim Finch PHONE NO : 865 2433969
400 Erin Drive SE DECISION MADE: 10-MAY-21
Knoxville TN 37919 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endo Motor
Guilin Woodpecker Medical Instrume510(k) NO: K203320(Traditional)
ATTN: Alex Wang PHONE NO : 0086 773 2350532
Information Industrial Park, GuiliSE DECISION MADE: 10-MAY-21
Guilin CN 541004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SpyGlass Discover Retrieval Basket
Boston Scientific Corporation 510(k) NO: K203322(Traditional)
ATTN: Lindsay Forys PHONE NO : 508 6836317
100 Boston Scientific Way SE DECISION MADE: 26-MAY-21
Marlborough MA 01749 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quick-20m
CGX, LLC 510(k) NO: K203331(Third Party - Traditional)
ATTN: Spencer Linton PHONE NO : 858 8649400
8445 Camino Sante Fe, Suite 104 SE DECISION MADE: 20-MAY-21
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VR101 Lubricating Intravaginal Ring
J3 Bioscience, Inc. 510(k) NO: K203377(Traditional)
ATTN: R. Tyler McCabe PHONE NO : 801 5509956
825 North 300 West, Suite N231 SE DECISION MADE: 20-MAY-21
Salt Lake City UT 84103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MC3 Crescent Jugular Dual Lumen Catheter
MC3, Inc. 510(k) NO: K203409(Traditional)
ATTN: Martha Rumford PHONE NO : 734 9959089 232
2555 Bishop Circle West SE DECISION MADE: 03-MAY-21
Dexter MI 48130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Isolation Gown
Yanbian Pacific Textile Co., LTD 510(k) NO: K203415(Traditional)
ATTN: Juan Zhuang PHONE NO : 86 138 63977758
Longjing industry concentration arSE DECISION MADE: 20-MAY-21
Longjing city CN 133400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Penumbra System (Reperfusion Catheter RED 62)
Penumbra, Inc. 510(k) NO: K203440(Traditional)
ATTN: Aditi Kolla PHONE NO : 510 9952010
One Penumbra Place SE DECISION MADE: 20-MAY-21
Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)
CapNostics, LLC 510(k) NO: K203450(Traditional)
ATTN: Martin von Dyck PHONE NO : 610___ 4421363
9724 Colts Neck Lane SE DECISION MADE: 04-MAY-21
Concord NC 28027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CryoVIVE
Recens Medical Inc. 510(k) NO: K203481(Traditional)
ATTN: Yeonui Lee PHONE NO : 82 31 80433064
908, SK V1 center, 830 DongtansunhSE DECISION MADE: 13-MAY-21
Hwaseong-si KR 18468 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D function
ITO CO., LTD. 510(k) NO: K203525(Traditional)
ATTN: Takeshi Kobayashi PHONE NO : 81 48 2525015
3-1-8 Sakae-cho SE DECISION MADE: 05-MAY-21
Kawaguchi-shi JP 332-0017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASSALLO GT Hybrid
Filmecc Co., Ltd. 510(k) NO: K203529(Traditional)
ATTN: Toshiya Osawa PHONE NO : 81 52 7681212
1703 Wakita-cho, Moriyama-ku SE DECISION MADE: 04-MAY-21
Nagoya JP 463-0024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tablet Application
Smith & Nephew 510(k) NO: K203566(Traditional)
ATTN: Sean Reynolds PHONE NO : 978 2892639
150 Minuteman Rd SE DECISION MADE: 13-MAY-21
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Karl Storz Radel Sterilization Trays
Karl Storz Endoscopy America Inc 510(k) NO: K203572(Traditional)
ATTN: Leigh Spotten PHONE NO : 424 2188376
2151 E Grand Ave SE DECISION MADE: 07-MAY-21
El Segundo CA 90245-5017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YUWELL infrared ear thermometer: YHT101, YHT200
Jiangsu Yuyue Medical Equipment & 510(k) NO: K203583(Traditional)
ATTN: Yuzhuo Wang PHONE NO : 0511 86 900827
Yunyang Industrial Park, Danyang, SE DECISION MADE: 20-MAY-21
Jiangsu CN 212300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoolSeal Reveal
Bolder Surgical, LLC 510(k) NO: K203640(Traditional)
ATTN: Nicholas Wong PHONE NO : 720 2877130
331 S. 104th Street, Suite 200 SE DECISION MADE: 06-MAY-21
Louisville CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)
Innovative Health, LLC. 510(k) NO: K203655(Traditional)
ATTN: Rick Ferreira PHONE NO : 877 4003740
1435 North Hayden Road, Suite 100 SE DECISION MADE: 04-MAY-21
Scottsdale AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action
Olympus Winter & Ibe GmbH 510(k) NO: K203682(Traditional)
ATTN: Katharina Campbell PHONE NO : 49 40 669662997
Kuehnstr. 61 SE DECISION MADE: 17-MAY-21
Hamburg DE 22045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index
Edwards lifesciences, LLC 510(k) NO: K203687(Traditional)
ATTN: Varad Raghuwanshi PHONE NO : 949 7564502
1 Edwards Way SE DECISION MADE: 28-MAY-21
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoLink Sfx Implant System
In2Bones USA, LLC 510(k) NO: K203698(Traditional)
ATTN: Christine Scifert PHONE NO : 901 8318053
6000 Poplar Ave, Suite 115 SE DECISION MADE: 04-MAY-21
Memphis TN 38119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Storz Medical MAGNETOLITH Muscle Stimulator
Storz Medical AG 510(k) NO: K203710(Traditional)
ATTN: Pavel Novak PHONE NO : 41 716 774513
Lohstampfestrasse 8 SE DECISION MADE: 03-MAY-21
Tägerwilen CH CH-8274 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HeRO Graft, HeRO Adapter
Merit Medical Systems, Inc. 510(k) NO: K203724(Traditional)
ATTN: Susan Christensen PHONE NO : 801 2084789
1600 West Merit Parkway SE DECISION MADE: 25-MAY-21
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable
Ambu A/S 510(k) NO: K203749(Traditional)
ATTN: Karina Matthiesen PHONE NO : 45 2775 2000
Baltorpbakken 13 SE DECISION MADE: 03-MAY-21
Ballerup DK 2750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tokuyama Universal Bond II
Tokuyama Dental Corporation 510(k) NO: K203760(Traditional)
ATTN: Keith A. Barritt PHONE NO : 011 81 338352261
38-9 Taitou 1-chome, Taitou-ku SE DECISION MADE: 25-MAY-21
Tokyo JP 110-0016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JWX-1 Plus (Navigo 16"/Navigo 24")
Yamaha Motor CO., LTD. 510(k) NO: K203806(Traditional)
ATTN: Michiyo Yamazaki PHONE NO : 81 538 322106
2500 Shingai SE DECISION MADE: 21-MAY-21
Iwata JP 438-8501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FuseForce™ Flex Dynamic Compression System
Wright Medical 510(k) NO: K203832(Traditional)
ATTN: Jonathan DiMotta PHONE NO : 901 8674121
1023 Cherry Road SE DECISION MADE: 07-MAY-21
Memphis TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed Tri Pulse Compression Garment
RENU Medical, Inc 510(k) NO: K203847(Traditional)
ATTN: Darren DeMerritt PHONE NO : 425 3531110
830 80th ST SW Suite 100 SE DECISION MADE: 07-MAY-21
Everett WA 98203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INVU by Nuvo
Nuvo-Group Ltd. 510(k) NO: K210025(Traditional)
ATTN: Chen Rubinstein PHONE NO : 972 54 3063996
Yigal Alon 94. St, Alon Tower 1 SE DECISION MADE: 28-MAY-21
Tel Aviv IL 6789155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OTE MPS 045 Multi-purpose Lens Care Solution
OTE North America LLC 510(k) NO: K210051(Traditional)
ATTN: Nathan Rosenberg PHONE NO : 516 3710225
40 Bayview Ave SE DECISION MADE: 26-MAY-21
Inwood NY 11096 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ImagePilot
Konica Minolta, Inc. 510(k) NO: K210066(Special)
ATTN: Tsutomu Fukui PHONE NO : 81 42 5898429
1 Sakura-machi SE DECISION MADE: 06-MAY-21
Hino-shi JP 191-8511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOLOSCOPE-i
Real View Imaging Ltd. 510(k) NO: K210072(Traditional)
ATTN: Yehudit Kraizer PHONE NO : 972 72 2200177
4 Hatnufa St. SE DECISION MADE: 14-MAY-21
Yokneam IL 2069202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vitals360 Multi-Vitals Mobile Monitor
VoCare, Inc. 510(k) NO: K210086(Traditional)
ATTN: Steve Peabody PHONE NO : 317 6580005
4950 Turkey Foot Road SE DECISION MADE: 20-MAY-21
Zionsville IN 46077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Hair Removal Device (Model: KCA423)
Shenzhen Boyuan Intelligent Electr510(k) NO: K210119(Traditional)
ATTN: Cheryl Yang PHONE NO : 86 075 589373426
RM202-203, Y2 Building, Chuangyi PSE DECISION MADE: 21-MAY-21
Shenzhen CN 510(k) STATEMENT
DEVICE: NextAR RSA Platform
Medacta International SA 510(k) NO: K210153(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 12-MAY-21
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diode Laser Therapy Systems
Beijing Kes Biology Technology CO.510(k) NO: K210168(Traditional)
ATTN: Wei Meng Meng PHONE NO : 86 10 60998698
PingguyuanZhongguancun Science AndSE DECISION MADE: 10-MAY-21
Beijing CN 101204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Overjet Dental Assist
Overjet, Inc. 510(k) NO: K210187(Traditional)
ATTN: Adam Heroux PHONE NO : 617 8230515
560 Harrison Ave, Unit 403 SE DECISION MADE: 19-MAY-21
Boston MA 02118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: coraCross
Reflow Medical 510(k) NO: K210188(Special)
ATTN: Krystal Santiago PHONE NO : 949 4810399
208 Avenida Fabricante #100 SE DECISION MADE: 28-MAY-21
San Clemente CA 92672 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Identity Imprint Knee Replacement System
Conformis Inc. 510(k) NO: K210191(Traditional)
ATTN: Kara Johnson PHONE NO : 781 8325402
600 Technology Park Drive SE DECISION MADE: 06-MAY-21
Billerica MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock
Set Medikal Sanayi Ve Ticaret Anon510(k) NO: K210200(Special)
ATTN: Mehice Ozturk PHONE NO : 90 212 6894828
Osmangazi Mahallesi Maresal Fevzi SE DECISION MADE: 14-MAY-21
Istanbul TR 34522 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System
NuVasive, Incorporated 510(k) NO: K210214(Traditional)
ATTN: Olga Lewis PHONE NO : 858 3866456
7475 Lusk Blvd. SE DECISION MADE: 24-MAY-21
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Needleless Connector
Jiangsu Caina Medical Co.,Ltd 510(k) NO: K210217(Traditional)
ATTN: Jianwei Pan PHONE NO : 86 0510 86866666 8027
No.23, Huanxi Rd, Zhutang Town SE DECISION MADE: 17-MAY-21
Jiangyin CN 214415 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGICAL MASK, Model Name:C015
Qingdao Hainuo Biological Engineer510(k) NO: K210218(Traditional)
ATTN: Raphael Wang PHONE NO :
Industrial Park, Jiangshan Town, LSE DECISION MADE: 07-MAY-21
Qingdao CN 266000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CINA CHEST
Avicenna.AI 510(k) NO: K210237(Traditional)
ATTN: Stephane Berger PHONE NO : 33 6 12122813
93 avenue du Sorbiers, Zone AtheliSE DECISION MADE: 19-MAY-21
La Ciotat FR 13600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xoran Workstation, Model 10050
Xoran Technologies LLC 510(k) NO: K210257(Traditional)
ATTN: Mark McGarrow PHONE NO : 734 418 5125
5210 S. State Rd. SE DECISION MADE: 20-MAY-21
Ann Arbor MI 48108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infant Phototherapy Equipment
Bistos Co., Ltd. 510(k) NO: K210289(Third Party - Traditional)
ATTN: Dae Eun Kim PHONE NO : 82 31 7500340
7th Fl. A Bldg., Woolim Lions VallSE DECISION MADE: 28-MAY-21
Seongnam-si KR 13201 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GR-14 Resin System
Pro3dure Medical GmbH 510(k) NO: K210298(Traditional)
ATTN: Frank Gischer PHONE NO : 49 02374 92005014
Am Burgberg 13 SE DECISION MADE: 05-MAY-21
Iserlohn DE 58642 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical mask
Anhui JBH Medical Apparatus Co., L510(k) NO: K210302(Traditional)
ATTN: Dandan Yang PHONE NO : 0086 550 8108866
No. 116 Qicang Road, Mingguang CitSE DECISION MADE: 14-MAY-21
Chuzhou CN 239400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Mask
Jin Pin Electrical CO., LTD. Zhuha510(k) NO: K210304(Traditional)
ATTN: Rongfeng Yu PHONE NO : 0086 756 6829666
No. 1 Shuanglin East Road, Da Lin SE DECISION MADE: 04-MAY-21
Zhuhai CN 519090 510(k) STATEMENT
DEVICE: GII Spinal Fixation System
Coligne AG 510(k) NO: K210306(Special)
ATTN: Robert B Lange PHONE NO : 41 43 3438000
Utoquai 43 SE DECISION MADE: 19-MAY-21
Zurich CH 8008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AutoCap RX
Boston Scientific Corporation 510(k) NO: K210353(Traditional)
ATTN: Kyra McNamara PHONE NO : 508 6834449
100 Boston Scientific Way SE DECISION MADE: 06-MAY-21
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neurescue device
Neurescue Aps 510(k) NO: K210358(Traditional)
ATTN: Habib Forest PHONE NO : 43 53 536760
Kobmagergade 53, 2 SE DECISION MADE: 21-MAY-21
Copenhagen DK 1150 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blue Nitrile Powder Free Patient Examination Glove, Non Sterile
Onetexx SDN BHD 510(k) NO: K210366(Traditional)
ATTN: Freddy Low PHONE NO : 605 8070666
No 73-86, Jalan Logam 5, PerindustSE DECISION MADE: 07-MAY-21
Kamunting MY 34600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Glove
Pastel Glove Sdn Bhd 510(k) NO: K210369(Traditional)
ATTN: Siou Wei Law PHONE NO : 60 195 525000
PT285724, Jalan Pusing, Taman PeriSE DECISION MADE: 13-MAY-21
Pusing MY 31550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electrosurgical accessory
Dornier MedTech America Inc. 510(k) NO: K210394(Traditional)
ATTN: John Hoffer PHONE NO : 770 5146163
1155 Roberts Blvd, Suite 100 SE DECISION MADE: 19-MAY-21
Kennesaw GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
Bio Compression Systems, Inc. 510(k) NO: K210417(Traditional)
ATTN: Marc Somelofski PHONE NO : 201 9390716
120 West Commercial Ave SE DECISION MADE: 14-MAY-21
Moonachie NJ 07074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Catalyft PL Expandable Interbody System
Medtronic Sofamor Danek, USA Inc. 510(k) NO: K210425(Traditional)
ATTN: Alex Underberg PHONE NO : 901 3441443
1800 Pyramid Place SE DECISION MADE: 24-MAY-21
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HS40 Diagnostic Ultrasound System
Samsung Medison CO., LTD. 510(k) NO: K210426(Traditional)
ATTN: Ju Jee Young PHONE NO : 82 2 21940861
3366, Hanseo-ro, Nam-myeon SE DECISION MADE: 13-MAY-21
Hongcheon-gun KR 25108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Automatic Arm Electronic Blood Pressure Monitor
Shenzhen LEPU Intelligent Medical 510(k) NO: K210435(Traditional)
ATTN: Aaron Lin PHONE NO : 86 755 86952278
North side of floor 3, BLD 9 BaiWaSE DECISION MADE: 12-MAY-21
Shenzhen CN 518055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive MOD-EX XLIF Interbody System
NuVasive, Incorporated 510(k) NO: K210439(Traditional)
ATTN: Manthan J. Damani PHONE NO : 858 4582272
7475 Lusk Blvd. SE DECISION MADE: 12-MAY-21
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OrthoGold 100
Tissue Regeneration Technologies, 510(k) NO: K210451(Traditional)
ATTN: John Warlick PHONE NO :
251 Heritage Walk SE DECISION MADE: 05-MAY-21
Woodstock GA 30188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NitriTec Vinyl Glove Powder Free Blue
Zhonghong Pulin Medical Products C510(k) NO: K210460(Traditional)
ATTN: Jia Yongmin PHONE NO : 86 137 84613997
West Industrial Park, Luannan CounSE DECISION MADE: 17-MAY-21
Tangshan CN 063500 510(k) STATEMENT
DEVICE: EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle
Cook Ireland Ltd. 510(k) NO: K210476(Traditional)
ATTN: Fay Dalton PHONE NO : 011 353 61334440
O'Halloran Road, National TechnoloSE DECISION MADE: 20-MAY-21
Limerick IE V94N8X2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family)
PENTAX of America, Inc. 510(k) NO: K210485(Traditional)
ATTN: William Goeller PHONE NO : 201 5712300 2318
3 Paragon Drive SE DECISION MADE: 13-MAY-21
Montvale NJ 07645-1782 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nautilus Nitrile Exam Gloves, Nautilus Nitrile Chemo-Rated Exam Gloves
Nautilus Gloves LLC 510(k) NO: K210496(Abbreviated)
ATTN: Mesh Gelman PHONE NO : 646 2836334
767 5th Avenue 15th Floor SE DECISION MADE: 26-MAY-21
Manhattan NY 10153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Synthetic Examination Gloves
Shandong Shengshixincheng Medical 510(k) NO: K210520(Traditional)
ATTN: Ping Wang PHONE NO : 86 155 50323002
No.28 Aluminum Deep Processing IndSE DECISION MADE: 26-MAY-21
Binzhou CN 256200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dr. Yglo Wart Remover
The OTC Lab Healthcare B.V. 510(k) NO: K210529(Traditional)
ATTN: Albert Swane PHONE NO : 0031 85 4444202
Fred. Roeskestraat 115 SE DECISION MADE: 06-MAY-21
Amsterdam NL 1076EE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UltraLight LED System
Rohrer Aesthetics, LLC 510(k) NO: K210535(Traditional)
ATTN: Mark Rohrer PHONE NO : 205 3561172
105 Citation Court SE DECISION MADE: 24-MAY-21
Birmingham AL 35209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Irrisept Antimicrobial Wound Lavage
Irrimax Corporation 510(k) NO: K210536(Traditional)
ATTN: Christy Coleman PHONE NO : 770 8073355
1665 Lakes Parkway, Suite 102 SE DECISION MADE: 28-MAY-21
Lawrenceville GA 30043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ohlendorf Clear Aligner
Ohlendorf Appliance Laboratory 510(k) NO: K210540(Traditional)
ATTN: Kevin Ohlendorf PHONE NO : 800 3258921
2840 Clark Avenue SE DECISION MADE: 19-MAY-21
St. Louis MO 63103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Steam-Dot Process Indicator
Propper Manufacturing Co., Inc. 510(k) NO: K210553(Abbreviated)
ATTN: Andrew Sharavara PHONE NO : 1 718 8691252
36-04 Skillman Avenue SE DECISION MADE: 19-MAY-21
Long Island City NY 11101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Symbia VA10A Family
Siemens Medical Solutions USA, Inc510(k) NO: K210557(Traditional)
ATTN: Tabitha Estes PHONE NO : 865 8044553
810 Innovation Drive SE DECISION MADE: 12-MAY-21
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neurodyn V2.0, Neurodyn Aussie V2.0
Ibramed Equipamentos Medicos 510(k) NO: K210572(Traditional)
ATTN: Fabio Alexandre Pinto PHONE NO : 55 19 38179636
Av. Dr. Carlos Burgos, 2800 - JardSE DECISION MADE: 11-MAY-21
Amparo BR 13901-080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Actis DuoFix Hip Prosthesis- Collarless
DePuy Ireland UC 510(k) NO: K210581(Traditional)
ATTN: Elaine Pears PHONE NO : 44 7795 389956
Loughbeg SE DECISION MADE: 20-MAY-21
Ringaskiddy IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUX-Dx Insertable Cardiac Monitor
Boston Scientific Corporation 510(k) NO: K210608(Special)
ATTN: Melissa Klamerus PHONE NO : 612 2476878
4100 Hamline Ave North SE DECISION MADE: 25-MAY-21
St. Paul MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantum Mini Ventilation Module
Spectrum Medical Ltd. 510(k) NO: K210669(Traditional)
ATTN: Colleen Powell PHONE NO : 44 01242 387082
Harrier 4, Meteor Business Park, CSE DECISION MADE: 04-MAY-21
Gloucestershire GB GL29QL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EasyWhip
Winter Innovations, Inc. 510(k) NO: K210675(Traditional)
ATTN: Lia Winter PHONE NO : 412 5510248
2450 EJ Chapman Drive, Suite 114 SE DECISION MADE: 03-MAY-21
Knoxville TN 37996 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOTA Cloud Imaging
Sota Precision Optics, Inc. dba SO510(k) NO: K210682(Traditional)
ATTN: Edward Johansen PHONE NO : 1 714 5326100
1073 North Batavia Street, Suite BSE DECISION MADE: 04-MAY-21
Orange CA 90404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClotTriever Thrombectomy System
Inari Medical, Inc. 510(k) NO: K210689(Traditional)
ATTN: Larry Boucher PHONE NO : 949 6008433
9 Parker, Suite 100 SE DECISION MADE: 12-MAY-21
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3
Defender Safety Inc. 510(k) NO: K210705(Abbreviated)
ATTN: Nahal Islam PHONE NO : 1 855 6433336
30 Skyline Drive SE DECISION MADE: 06-MAY-21
Plainview NY 11803 510(k) STATEMENT
DEVICE: CONDUIT Instruments
Medos International, SARL 510(k) NO: K210728(Traditional)
ATTN: Christine Cahillane PHONE NO : 508 8283064
Chemin-Blanc 38 SE DECISION MADE: 06-MAY-21
Le Locle CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
STERIS Corporation 510(k) NO: K210737(Special)
ATTN: Jennifer Nalepka PHONE NO : 440 3927458
5960 Heisley Road SE DECISION MADE: 12-MAY-21
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)
Meditech Gloves SDN BHD 510(k) NO: K210755(Traditional)
ATTN: Effendi Tenang PHONE NO : 606 7997742
PT 3345, Jalan Permata 1/3, Arab MSE DECISION MADE: 07-MAY-21
Nilai MY 71800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Shandong Jieshi Medical Products C510(k) NO: K210774(Traditional)
ATTN: Li Biao PHONE NO : 86 530 2061157
North Road, Fumin Avenue, Qinghe SSE DECISION MADE: 14-MAY-21
Heze CN 274400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Shandong Shangwei Medical Products510(k) NO: K210780(Traditional)
ATTN: Li Hua PHONE NO : 86 530 2069778
North Road, Fumin Avenue, Qinghe SSE DECISION MADE: 14-MAY-21
Heze CN 274400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Vinyl Patient Examination Gloves
Yunnan Huazhiyuan Medical Technolo510(k) NO: K210799(Traditional)
ATTN: Yun Gao PHONE NO : 86 18 252909158
Yangjie Industrial Park, Jianshui SE DECISION MADE: 14-MAY-21
Honghe Hani and Yi Autonomous Pref510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)
Conformis, Inc. 510(k) NO: K210809(Traditional)
ATTN: Mary Kruitwagen PHONE NO : 781 3459038
600 Technology Park Drive, Fourth SE DECISION MADE: 12-MAY-21
Billerica MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Face Mask
Biobase Scientific (Shandong) Co.,510(k) NO: K210815(Traditional)
ATTN: Qingxiang Hou PHONE NO : 86 531 81219858
No.1777 Dazheng Road, High-Tech DiSE DECISION MADE: 13-MAY-21
Jinan CN 250000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: True Tulip, True M.I.S.
Innovative Surgical Designs, Inc. 510(k) NO: K210816(Special)
ATTN: Jon Rinehart PHONE NO : 217 8368522 103
3903 S. Walnut St. SE DECISION MADE: 18-MAY-21
Bloomington IN 47401 510(k) STATEMENT
DEVICE: Persona Revision Knee System Femoral Metaphyseal Cones
Zimmer, Inc. 510(k) NO: K210829(Traditional)
ATTN: Romil Sheth PHONE NO : 574 2688196
1800 W. Center Street SE DECISION MADE: 18-MAY-21
Warsaw IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reliance Spinal Screw System
Reliance Medical Systems, LLC 510(k) NO: K210874(Special)
ATTN: Bret M Berry PHONE NO : 801 7187467
545 West 500 South, Suite 100 SE DECISION MADE: 13-MAY-21
Bountiful UT 84010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vereos PET/CT
Philips Medical Systems Nederland 510(k) NO: K210880(Traditional)
ATTN: Nimit Shah PHONE NO : 440 8694409
Veenpluis 4-6 SE DECISION MADE: 19-MAY-21
Best NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pathfinder Endoscope Cap
Neptune Medical, Inc. 510(k) NO: K210915(Traditional)
ATTN: Alex Tilson PHONE NO : 650 3072176
1828 El Camino Real, Suite 508 SE DECISION MADE: 25-MAY-21
Burlingame CA 94010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single Use Injection Needle
Anrei Medical (Hangzhou) Co., Ltd.510(k) NO: K210917(Traditional)
ATTN: Huibing Yang PHONE NO : 86 571 86913333 8658
No.3 Ave.8, HEDA SE DECISION MADE: 28-MAY-21
Hangzhou CN 310018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MicroFrance Monopolar and Bipolar Electrosurgical Instruments
Integra MicroFrance 510(k) NO: K210942(Traditional)
ATTN: Malena Zammetti PHONE NO : 717 8188774
Le Pavillon SE DECISION MADE: 14-MAY-21
Saint Aubin Le Monial Allier FR 0510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Air Pressure Therapy System: VU-IPC06
Xiamen Weiyou Intelligent Technolo510(k) NO: K210967(Traditional)
ATTN: Yong Sun PHONE NO : 86 0592 6251545
Unit 101-401, No.6 Xianghong Road,SE DECISION MADE: 11-MAY-21
Xiamen CN 361021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: High Performance Antimicrobial Gelling Fiber with Silver
Advanced Medical Solutions Ltd. 510(k) NO: K210974(Special)
ATTN: Kay McGrath PHONE NO : 44 1606 863500
Premier Park, 33, Winsford IndustrSE DECISION MADE: 12-MAY-21
Winsford GB CW7 3RT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
Bausch & Lomb Incorporated 510(k) NO: K210975(Traditional)
ATTN: Barbara Klube-Falso PHONE NO : 585 3388503
1400 North Goodman Street SE DECISION MADE: 24-MAY-21
Rochester NY 14609 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-Dent 1000
EnvisionTEC GmbH 510(k) NO: K210977(Traditional)
ATTN: Ruediger van Bernum PHONE NO : 49 2043 987545
Brusseler Strabe 51 SE DECISION MADE: 25-MAY-21
Gladbeck DE D-45968 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Prelivia
Rehabtronics Inc. 510(k) NO: K210979(Traditional)
ATTN: Mike Pearson PHONE NO : 1 780 7015167 704
#4352, 10230 Jasper Avenue SE DECISION MADE: 13-MAY-21
Edmonton CA T5J 4P6 510(k) STATEMENT
DEVICE: C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner
MEDTEC, Inc. dba CIVCO Medical Sol510(k) NO: K211001(Traditional)
ATTN: Alena Newgren PHONE NO : 319 2486650
Radiotherapy 1401 8th Street SE SE DECISION MADE: 20-MAY-21
Orange City IA 51041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GMK Spherika Femurs and Fixed Tibial Trays Plus
Medacta International SA 510(k) NO: K211004(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 13-MAY-21
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bose SoundControl Hearing Aids
Bose Corporation 510(k) NO: K211008(Special)
ATTN: Bryn Kieras PHONE NO : 978 4572972
The Mountain SE DECISION MADE: 05-MAY-21
Framingham MA 01701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Corvus Radiation Therapy Planning System
Best Nomos 510(k) NO: K211034(Special)
ATTN: Vineet Gupta PHONE NO : 412 3126700
One Best Drive SE DECISION MADE: 06-MAY-21
Pittsburgh PA 15202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation 510(k) NO: K211037(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoshigami SE DECISION MADE: 17-MAY-21
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LigaPASS® Spinal System, CD Horizon™ Spinal System
Medtronic, Inc. 510(k) NO: K211057(Traditional)
ATTN: Taylor Gold West PHONE NO : 720 8902322
1800 Pyramid Place SE DECISION MADE: 27-MAY-21
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Breast Volume Navigator (BVN) Model G-2000
MetriTrack, Inc. 510(k) NO: K211098(Third Party - Traditional)
ATTN: Mirela Wohlford PHONE NO : 708 4983578
4415 W. Harrison Street Suite 243 SE DECISION MADE: 26-MAY-21
Hillside IL 60162 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AcQGuide MAX Steerable Sheath
Acutus Medical, Inc. 510(k) NO: K211100(Third Party - Traditional)
ATTN: Serena Sanginthirath PHONE NO : 442 2326178
2210 Faraday Ave., Suite 100 SE DECISION MADE: 14-MAY-21
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Ear-Friendly Mask
Ray Co., Ltd. 510(k) NO: K211105(Third Party - Traditional)
ATTN: Changhwan Lee PHONE NO : 82 31 6051000
38, Simin-daero, Manan-gu SE DECISION MADE: 17-MAY-21
Anyang-si KR 14098 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: OIC External Fixation System
Orthopaedic Implant Company 510(k) NO: K211112(Special)
ATTN: Douglas Fulton PHONE NO : 775 6368281
770 Smithridge Dr. #400 SE DECISION MADE: 05-MAY-21
Reno NV 89502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A1AT Genotyping Test
Progenika Biopharma S.A., a Grifol510(k) NO: K211115(Special)
ATTN: Diego Tejedor PHONE NO : 34 944 064525
Ibaizabal bidea, Edificio 504, ParSE DECISION MADE: 13-MAY-21
Derio ES 48160 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGNA 7.0T
GE Medical Systems, LLC 510(k) NO: K211118(Special)
ATTN: Brian R. Zielski PHONE NO : 262 2273596
3200 Grandview Blvd SE DECISION MADE: 13-MAY-21
Waukesha WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NPseal
Guard Medical Inc. 510(k) NO: K211130(Special)
ATTN: Machiel Van Der Leest PHONE NO : 888 4173644
1221 Brickell Avenue, Suite 900 SE DECISION MADE: 14-MAY-21
Miami FL 33131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIB Stent Placement Catheter
NuMED, Inc 510(k) NO: K211134(Special)
ATTN: Nichelle LaFlesh PHONE NO : 315 3284491
2880 Main Street SE DECISION MADE: 27-MAY-21
Hopkinton NY 12965 510(k) STATEMENT
DEVICE: LEGION CR Porous Plus HA Femoral Components
Smith & Nephew, Inc. 510(k) NO: K211246(Special)
ATTN: Leah Hawkins PHONE NO : 901 4638447
7135 Goodlett Farms Parkway SE DECISION MADE: 24-MAY-21
Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ViperCath XC Peripheral Exchange Catheter
Cardiovascular Systems, Inc. 510(k) NO: K211251(Special)
ATTN: Erika Huffman PHONE NO : 651 2591608
1225 Old Hwy 8 NW SE DECISION MADE: 26-MAY-21
St. Paul MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PlasmaWave
ManaMed, Inc. 510(k) NO: K211253(Special)
ATTN: Trevor Theriot PHONE NO : 702 7811117
5240 W. Charleston Blvd. SE DECISION MADE: 26-MAY-21
Las Vegas NV 89146 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, Endoskeleton TT Interbody System
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K211258(Special)
ATTN: Kelly McDonnell PHONE NO : 651 2699806
1800 Pyramid Place SE DECISION MADE: 26-MAY-21
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Axis Charcot Fixation System
Extremity Medical, LLC. 510(k) NO: K211261(Special)
ATTN: Mary Hoffman PHONE NO : 973 5888980
300 Interpace Parkway, Suite 410 SE DECISION MADE: 28-MAY-21
Parsippany NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray
Ethicon Endo-Surgery, LLC 510(k) NO: K211273(Special)
ATTN: Nathan Anderson PHONE NO : 787 2726144
475 Calle C SE DECISION MADE: 21-MAY-21
Guaynabo PR 00969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AirMax Procedure Mask
PremiumEStore, LLC 510(k) NO: K211275(Third Party - Traditional)
ATTN: Brent Dillie PHONE NO : 888 2671801
2601 Reliance Drive, Suite 102 SE DECISION MADE: 25-MAY-21
Virginia Beach VA 23452 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: Aqua Medical RF Vapor System
Aqua Medical, Inc. 510(k) NO: K211282(Special)
ATTN: Lloyd Mencinger PHONE NO : 469 2361895
191 West Second St. SE DECISION MADE: 27-MAY-21
Santa Ana CA 92701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fassier-Duval Telescopic IM System
Pega Medical Inc. 510(k) NO: K211292(Special)
ATTN: Enrique Garcia PHONE NO : 450 6885144
1111 Autoroute Chomedey SE DECISION MADE: 26-MAY-21
Laval CA H7W 5J8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pathfinder Endoscope Overtube
Neptune Medical, Inc. 510(k) NO: K211301(Special)
ATTN: Alex Tilson PHONE NO : 1 650 3072176
1828 El Camino Real SE DECISION MADE: 28-MAY-21
Burlingame CA 94010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LINQ II Insertable Cardiac Monitor
Medtronic, Inc. 510(k) NO: K211304(Special)
ATTN: Andrea Artman PHONE NO : 419 7084172
8200 Coral Sea Street NE SE DECISION MADE: 28-MAY-21
Mounds View MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GalaSTITCH Absorbable Monofilament Suture
Tepha, Inc. 510(k) NO: K211307(Special)
ATTN: Jodie Giordano PHONE NO : 781 4758849
99 Hayden Avenue, Suite 360 SE DECISION MADE: 27-MAY-21
Lexington MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AtriCure Isolator® Synergy™ Surgical Ablation System
AtriCure, Inc. 510(k) NO: K211311(Special)
ATTN: Jon McElwee PHONE NO : 513 7959127
7555 Innovation Way SE DECISION MADE: 28-MAY-21
Mason OH 45040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Universal Viewer
GE Healthcare 510(k) NO: K211312(Special)
ATTN: John Braam PHONE NO : 262 3478240
500 W. Monroe Street SE DECISION MADE: 21-MAY-21
Chicago IL 60661-3671 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAXFRAME Multi-Axial Correction System (aka MAXFRAME)
Synthes (USA) Products, LLC 510(k) NO: K211313(Special)
ATTN: Suchitra Basu PHONE NO : 610 8361581
1301 Goshen Parkway SE DECISION MADE: 25-MAY-21
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems
Medos International SARL 510(k) NO: K211344(Special)
ATTN: Ariell Joiner PHONE NO : 908 2490182
Chemin-Blanc 38 SE DECISION MADE: 28-MAY-21
Le Locle CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rover
Micro-X Limited 510(k) NO: K211423(Special)
ATTN: Derek Rogers PHONE NO : 61 8 70993966
A14 6 Tonsley Boulevard SE DECISION MADE: 21-MAY-21
Cloverly Park AU 5042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Air Relax Plus Model AR-3.0
Diode Art Engineering doing busine510(k) NO: K211460(Third Party - Traditional)
ATTN: Beomjoon Lee PHONE NO : 1 323 2854231
9535 Brasher St SE DECISION MADE: 25-MAY-21
Pico Rivera CA 90660 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
TOTAL 510(k)s THIS PERIOD 196
TOTAL WITH SUMMARIES 185
TOTAL WITH STATEMENTS 11
