FDA 510(k) Application Details - K122502

Device Classification Name	Dressing, Wound, Collagen   More FDA Info for this Device
510(K) Number	K122502
Device Name	Dressing, Wound, Collagen
Applicant	HARBOR MEDTECH, INC. 4 JENNER SUITE 190 IRVINE, CA 92618 US Other 510(k) Applications for this Company
Contact	JERRY MEZGER Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	KGN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/16/2012
Decision Date	02/26/2013
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