K-number	K160679
Device name	WoundClot9
Applicant	Core Scientific Creation , Ltd.
Product code	QSY
Device class	Class U
Decision date	Aug 8, 2016
Decision	Substantially Equivalent
Regulation	—

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View the full FDA submission: accessdata.fda.gov

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WoundClot9

Everything you need for a 510(k) submission. Nothing you don't.