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U.S. Department of Health and Human Services

510(K) Premarket Notification
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reusable nibp cuff Orantech Inc. k173197 08/21/2018
radspeed fit SHIMADZU corporation k173517 03/30/2018
k2 zirkon blank white classic; k2 zirkon blank translucent; k2 blanks extreme translucent Yeti Dentalprodukte Gmbh k173971 11/15/2018
patriot spinal fixation system Valorus Spine k180324 04/06/2018
light based hair removal device Shenzhen GSD Tech Co., Ltd k180383 05/11/2018
contec oxygen concentrator Contec Medical System Co., Ltd. k180837 01/10/2019
evol spinal interbody system, evos lumbar interbody system Cutting Edge Spine, LLC k180891 05/04/2018
liaison helicobacter antigen, liaison helicobacter antigen control set DiaSorin Inc. k181464 08/31/2018
dc-70/dc-70t/dc-70 pro/dc-70 exp/dc-75/dc-78/dc-70s diagnostic ultrasound system Shenzhen Mindray Bio-Medical Electronics Co., LTD k181637 01/09/2019
adapt for gamma3, gamma3 Stryker GMBH k181848 10/12/2018

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