FDA 510(k) Application Details - K110757

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K110757
Device Name	Dressing, Wound, Drug
Applicant	TRIGEN LABORATORIES, INC. 248 LATITUDE LANE SUITE 104 LAKE WYLIE, SC 29710 US Other 510(k) Applications for this Company
Contact	GEORGE MCCAULEY 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	03/18/2011
Decision Date	08/19/2011
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