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U.S. Department of Health and Human Services

510(K) Premarket Notification
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elecsys cortisol ii, cortisol ii calset ROCHE DIAGNOSTICS k152227 04/27/2016
flash mini ostial system - 3.0mm x 8mm x 135cm, flash mini ostial system - 3.5mm x 8mm x 135cm, flash mini ostial system - 4.0mm x 8mm x 135cm, flash mini ostial system - 4.5mm x 8mm x 135cm OSTIAL CORPORATION k152485 02/16/2016
olea sphere v3.0 OLEA MEDICAL k152602 03/03/2016
terumo capiox sx18 oxygenator/ hardshell reservoir, terumo capiox sx18 oxygenator/ hardshell reservoir with xcoating, terumo capiox sx25 oxygenator/hardshell reservoir, terumo capiox sx25 oxygenator/hardshell reservoir with xcoating TERUMO CARDIOVASCULAR SYSTEMS CORP. k153140 12/02/2015
nmi port, nmi port ii NAVILYST MEDICAL, INC. k153228 12/04/2015
bladder scanner Caresono Technology Co., Ltd. k153581 04/08/2016
amiplivue hsv 1&2 assay QUIDEL CORPORATION k140029 03/26/2014
electrode for urinary incontinence GUANGZHOU FINECURE MEDICAL EQUIPMENT CO., LTD k140265 01/23/2015
integra external fixation system ASCENSION ORTHOPEDIC k140463 10/10/2014
starceram H.C. STARCK CERAMICS GMBH k140924 06/05/2014

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