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U.S. Department of Health and Human Services

510(K) Premarket Notification
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tremoflo c-100 airwave oscillometry system THORASYS Thoracic Medical Systems, Inc. k170185 09/12/2017
tao brush i.u.m.c. endometrial sampler Cook Incorporated k170603 05/24/2017
single use arthroscopic electrode (with pencil) Modern Medical Equipment Manufacturing Limited k170703 05/31/2018
dentis dental implant system Dentis Co.,Ltd. k171027 09/06/2017
non-sterile, single use, powder-free examination glove tested for use with chemotherapy drugs SEMPERIT INVESTMENTS ASIA PTE. LTD. k171378 09/14/2017
archflo ct midline Medcomp (dba Medical Components, Inc.) k171483 12/15/2017
pico 7 single use negative pressure wound therapy system Smith & Nephew Medical Limited k172005 02/02/2018
hysteroscopy system Chongquin Jinshan Science & Technology (Group) Co., Ltd. k172151 04/09/2018
bacterioscan 216dx system BacterioScan, Inc. k172412 05/01/2018
enseal x1 tissue sealer, straight jaw, 25 cm shaft length, enseal x1 tissue sealer, straight jaw, 37 cm shaft length, enseal x1 tissue sealer, curved jaw, 25 cm shaft length,enseal x1 tissue sealer, curved jaw, 37 cm shaft length,enseal x1 tissue sealer, curved jaw, 45 cm shaft length Ethicon Endo-Surgery, LLC k172580 11/20/2017

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