FDA 510(k) Application Details - K172155

Device Classification Name	More FDA Info for this Device
510(K) Number	K172155
Device Name	StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing
Applicant	StatGuard, LLC 7555 Cason Lane Gladstone, OR 97027 US Other 510(k) Applications for this Company
Contact	Gary Mills 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	07/17/2017
Decision Date	04/12/2018
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