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U.S. Department of Health and Human Services

510(K) Premarket Notification

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isr'obot mri-us fusion BIOBOT SURGICAL PTE LTD k161109 10/06/2016
dual top screw system JEIL MEDICAL CORPORATION k161335 02/23/2017
nanovis intervertebral body fusion system and forticore(r) NANOVIS LLC k161485 09/06/2016
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
curasite IZUN PHARMACEUTICALS k161991 03/03/2017
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
winback back 3se WINBACK USA CORP k162828 09/18/2017
nitrile powder free examination glove tested for use with chemotherapy drugs - aqua blue; nitrile powder free examination glove tested for use with chemotherapy drugs - violet blue; nitrile powder free examination glove tested for use with chemotherapy drugs - dark blue; nitrile powder free examina HARTALEGA NGC SDN. BHD. k162923 02/06/2017
rp lite 760r Mego Afek AC Ltd. k163280 01/27/2017

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