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U.S. Department of Health and Human Services

510(K) Premarket Notification

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ips e.max® press abutment solutions for viteo base ti IVOCLAR VIVADENT AG k160798 12/15/2016
powder free latex examination glove with protein labeling claim of 50ug/dm2 or less Viet Glove Corporation k162175 11/21/2016
hyperband GE Medical Systems, LLC k162403 11/18/2016
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
fingertip pulse oximeter md300cg11/md300cg51 BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. k160268 10/14/2016
isr'obot mri-us fusion BIOBOT SURGICAL PTE LTD k161109 10/06/2016
rts flexible 1 mpj implant w/grommets In2BonesUSA, LLC k153609 09/08/2016
nanovis intervertebral body fusion system and forticore(r) NANOVIS LLC k161485 09/06/2016
modified trevo provue retriever, trevo xp provue retriever 4x20mm, trevo xp provue retriever 3x20mm, trevo xp provue retriever 6x25mm, trevo xp provue retriever 4x30mm CONCENTRIC MEDICAL, INC. den150049 09/02/2016
xpert tv, xpert urine specimen collection kit, genexpert dx systems (gx-i, gx-ii, gx-iv, gx-xvi), genexpert infinity-48, genxpert infinity-48s and genexpert infinity-80 systems Cepheid k161619 08/29/2016

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