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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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Decision
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precice stryde system NuVasive Specialized Orthopedics, Inc. k180503 04/03/2018
safety wire guide introducer COOK Incorporated k180756 05/24/2018
atellica im brahms procalcitonin (pct) Siemens Healthcare Diagnostics Inc. k181002 07/16/2018
magnetom sola Siemens Medical Solutions USA, Inc. k181322 10/05/2018
fingertip pulse oximeter Beijing Choice Electronic Technology Co., Ltd. k181503 10/11/2018
alphenix, infx-8000v/b, v8.0 Canon Medical Systems Corporation k181670 07/25/2018
muscle trainer Shenzhen Kentro Medical Electronics Co., Ltd k181728 10/17/2018
elekta unity Elekta Limited k182076 12/04/2018
mis lockit abutments system, ot-equators and ball attachments MIS Implants Technologies Ltd. k182228 01/28/2019
exactech alteon highly polished femoral stem Exactech, Inc. k182462 11/08/2018

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