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U.S. Department of Health and Human Services

510(K) Premarket Notification
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surgiseal topical skin adhesive Adhezion Biomedical, LLC k130329 12/03/2013
capiox sx18 hollow fiber oxygenator with detachable hardshell reservoir, capiox sx25 hollow fiber oxgenator with detacha TERUMO CARDIOVASCULAR SYSTEMS CORP. k130359 03/13/2013
emerge monorail ptca dilatation catheter, emerge push monorail ptca dilatation catheter, emerge over-the-wire ptca dilat BOSTON SCIENTIFIC CORP. k130391 07/10/2013
jr implant system LK Consulting Group USA, Inc. k130694 06/19/2014
aftamed mouthwash; aftamed gel; aftamed spray; aftamed shield; aftamed junior gel BIOPLAX LIMITED k130959 04/04/2014
digital radiography cxdi-701c wireless, digital radiography cxdi-70ig wireless, digital radiography cxdi-801c wireless, CANON INC. k131106 07/03/2013
cd horizon spinal system MEDTRONIC SOFAMOR DANEK USA k131321 06/05/2013
tattoostar effect combo ASCLEPION LASER TECHNOLOGIES GMBH k131757 07/17/2014
philips dxl 12/16-lead ecg algorithm PHILIPS MEDICAL SYSTEMS k132068 09/26/2013
dc-8/ dc-8 pro/ dc-8 cv/ dc-8 exp/ dc-8s diagnostic ultrasound systems SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD k132341 08/15/2013

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