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U.S. Department of Health and Human Services

510(K) Premarket Notification
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kls martin individual patient solutions KLS Martin LP k163579 11/21/2017
pain therapy device Guangzhou Xinbo Electronic Co., Ltd. k163611 09/19/2017
modified bencox hip system Corentec Co., Ltd k150007 05/04/2015
st aia-pack 25-oh vitamin d, st aia-pack 25-oh vitamin d calibrator set, aia-pack 25-oh vitamin d control set, and st aia-pack 25-oh vitamin d pretreatment set TOSOH BIOSCIENCE, INC. k150270 10/26/2015
oxyless blood tubing set Oxyless Ltd k150304 02/24/2016
is4000 small clip applier, is4000 long bipolar forceps INTUITIVE SURGICAL, INC. k150837 04/29/2015
starband, starlight ORTHOMERICA PRODUCTS, INC. k151147 07/01/2015
caretaker continuous non-invasive blood pressure monitor, caretaker wireless vital signs monitor CARETAKER MEDICAL, LLC k151499 03/18/2016
gmate origin blood glucose monitoring system Philosys Inc. k151658 12/01/2015
aries hsv 1&2 assay cassettes - carton of 24 (ivd), aries hsv 1&2 assay protocol file kit (ivd), aries hsv 1&2 assay cassette (ivd) LUMINEX CORPORATION k151906 10/06/2015

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