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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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powder free vinyl patient examination glove, colored (yellow) KAIXING PLASTIC PRODUCTS CO., LITD. k160675 08/02/2016
cardiac trigger monitor, cardiac & regulatory synchronization monitor IVY BIOMEDICAL SYSTEMS INC. k151781 05/27/2016
esophyx® z device with serosafuse fasteners and accessories ENDOGASTRIC SOLUTIONS, INC. k160960 05/01/2016
elecsys cortisol ii, cortisol ii calset ROCHE DIAGNOSTICS k152227 04/27/2016
bladder scanner Caresono Technology Co., Ltd. k153581 04/08/2016
full automatic (nibp) blood pressure monitor Health & Life Co., Ltd. k160336 03/29/2016
olea sphere v3.0 OLEA MEDICAL k152602 03/03/2016
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
nmi port, nmi port ii NAVILYST MEDICAL, INC. k153228 12/04/2015
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

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