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U.S. Department of Health and Human Services

510(K) Premarket Notification
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trovita health science safe-t feed ready-to-feed pouch with enfit connector TrovRx, Inc. dba Trovita Health Science k163586 03/17/2017
advance capsule endoscope delivery device United States Endoscopy Group, Inc. k163495 03/10/2017
magnetos XPAND BIOTECHNOLOGY BV k161859 02/24/2017
scopis hybrid navigation system em Scopis GmbH k161491 02/09/2017
certa dose pd epinephrine 1mg/ml im/sc syringe CERTA DOSE, INC. k160589 01/19/2017
liquichek tumor marker control-level 1; liquichek tumor marker control-level 2; liquichek tumor marker control-level 3; liquichek tumor marker control- trilevel minipak BIO-RAD LABORATORIES k163015 01/10/2017
s-clean oneq-sl narrow implant system Dentis Co., Ltd. k161244 12/07/2016
single use curved cutters, single use circular staplers, single use linear cutters and reloads, single use endoscopic linear cutters and reloads, single use hemorrhoidal staplers, single use linear staplers and reloads VICTOR MEDICAL INSTRUMENTS CO.,LTD. k161757 12/05/2016
fastouch fixation system VIA SURGICAL LTD. k162252 11/14/2016
bd max vaginal panel, bd max instrument GENEOHM SCIENCES CANADA , INC (BD DIAGNOSTICS) den160001 10/28/2016

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