FDA 510(k) Application Details - K112215

Device Classification Name	More FDA Info for this Device
510(K) Number	K112215
Device Name	HEMCON HEMOSTATIC GEL
Applicant	HEMCON MEDICAL TECHNOLOGIES EUROPE, LTD. 10575 SW CASCADE AVENUE, SUITE 130 PORTLAND, OR 97223-4363 US Other 510(k) Applications for this Company
Contact	KENDRA RATHKEY 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	08/02/2011
Decision Date	04/12/2012
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