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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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nerbridge TOYOBO CO., LTD. k152967 06/22/2016
cascadia interbody system K2M k160547 03/24/2016
single use sphincterotome v (distal wireguided) kd-vc412q-0215 OLYMPUS MEDICAL SYSTEMS CORP. k160241 03/02/2016
logiq s7 expert GE Healthcare k160182 02/26/2016
diode laser therapy systems BEIJING SINCOHEREN SCIENCE AND TECH. DEVELOPMENT CO., LTD k152898 02/09/2016
k-y marilyn pleasure gel Reckitt Benckiser LLC k151884 01/11/2016
careview 1800l CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. k153492 12/24/2015
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
trinidad im thyroid stimulating hormone (tsh) assay, trinidad im tsh calibrators, trinidad immunoassay (im) system Siemens Healthcare Diagnostics,Inc. k151792 11/20/2015
erbe waterjet model erbejet® 2 system with hybridapc probe ERBE USA, INC. k143306 10/27/2015

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