FDA 510(k) Application Details - K093156

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K093156
Device Name	Dressing, Wound, Drug
Applicant	PRUGEN IP HOLDINGS, INC 8711 E PINNACLE PEAK ROAD SUITE C-201, PMB 225 SCOTTSDALE, AZ 85255 US Other 510(k) Applications for this Company
Contact	ROBERT L KNECHTEL 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	10/06/2009
Decision Date	06/24/2010
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