FDA 510(k) Application Details - K140313

Device Classification Name	More FDA Info for this Device
510(K) Number	K140313
Device Name	STOPSBLEEDING TOPICAL HEMOSTAT POWDER AND FOAM
Applicant	COAG MEDICAL LLC 4486 TIMBERLINE CT. VADNAIS HEIGHTS, MN 55127 US Other 510(k) Applications for this Company
Contact	BERNARD HORWATH Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/10/2014
Decision Date	07/28/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review