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U.S. Department of Health and Human Services

510(K) Premarket Notification

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dual output digital therapy massager Shenzhen OSTO Technology Co., Ltd. k172834 09/06/2018
seaspine spacer system (nanometalene)- hollywood, hollywood vi, ventura, pacifica; seaspine spacer system -hollywood, hollywood vi, ventura, pacifica; seaspine vu e·pod system SeaSpine Orthopedics Corporation k173260 12/04/2017
artas system Restoration Robotics, Inc. k173358 03/16/2018
parietex surgical mesh (modified into parietex hydrophilic 2d, 3d, anatomical mesh), parietex composite mesh (pco and pco-os references), parietex optimized composite mesh (pco-x, pco-fx and pco-osx references) Sofradim Production k173796 03/09/2018
logiq s7 expert GE Healthcare k160182 02/26/2016
single use sphincterotome v (distal wireguided) kd-vc412q-0215 OLYMPUS MEDICAL SYSTEMS CORP. k160241 03/02/2016
fingertip pulse oximeter md300cg11/md300cg51 BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. k160268 10/14/2016
cascadia interbody system K2M k160547 03/24/2016
ips e.max® press abutment solutions for viteo base ti IVOCLAR VIVADENT AG k160798 12/15/2016
cs-medical td 100 disinfector with td-5 and td-8 high level disinfectants, cs medical td-5 high level disinfectant, cs medical td-8 high level disinfectant CS Medical LLC k160921 11/03/2016

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