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U.S. Department of Health and Human Services

510(K) Premarket Notification
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altivate anatomic to reverse conversion module Encore Medical, L.P. k173073 12/26/2017
endoskeleton® tas interbody fusion device, endoskeleton® tas hyperlordotic interbody fusion device and endoskeleton® tcs interbody fusion device Titan Spine, LLC k173535 02/13/2018
ultrasound system 1300 BK Medical ApS k173569 02/23/2018
ez3d-i /e3 Ewoo Soft Co., Ltd. k173863 02/23/2018
anatomical shoulder system, anatomical shoulder domelock system, anatomical shoulder fracture system ZIMMER GMBH k160085 03/08/2016
chaorum implant system MEDIMECCA CO., LTD. k160536 01/05/2017
rockwell medical citrapure acid concetrate ROCKWELL MEDICAL k160847 10/20/2016
latex powder free polymer coated examination glove with protein labeling claim of 50 microgram or less per gram of glove HARTALEGA SDN. BHD. k161006 08/04/2016
endocam flex hd camera system 5521 RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION k161204 01/11/2017
liaison ebv igm serum control set DiaSorin Inc. k161522 06/30/2016

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