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U.S. Department of Health and Human Services

510(K) Premarket Notification

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trinidad im thyroid stimulating hormone (tsh) assay, trinidad im tsh calibrators, trinidad immunoassay (im) system Siemens Healthcare Diagnostics,Inc. k151792 11/20/2015
k-y marilyn pleasure gel Reckitt Benckiser LLC k151884 01/11/2016
kvue encompass srs insert (encompass insert), encompass srs standalone (encompass device), encompass srs mri immobilization device (encompass mri device, encompass intracranial fibreplast variable perf head only open view system, encompass intracranial fibreplast variable perf head only open view w QFIX k152321 12/04/2015
eclipse treatment planning system VARIAN MEDICAL SYSTEMS, INC. k152393 09/18/2015
diode laser therapy systems BEIJING SINCOHEREN SCIENCE AND TECH. DEVELOPMENT CO., LTD k152898 02/09/2016
nerbridge TOYOBO CO., LTD. k152967 06/22/2016
careview 1800l CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. k153492 12/24/2015
rts flexible 1 mpj implant w/grommets In2BonesUSA, LLC k153609 09/08/2016
s9 elouera RESMED CORP k140124 05/12/2014
medline neuro sponge MEDLINE INDUSTRIES, INC. k140369 09/26/2014

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