FDA 510(k) Application Details - K063517

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K063517
Device Name	Dressing, Wound, Drug
Applicant	HEALAGENICS, INC. 800 WEST CUMMINGS PARK SUITE 2900 WOBURN, MA 01801 US Other 510(k) Applications for this Company
Contact	PAUL STRATI Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	FRO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2006
Decision Date	02/16/2007
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