FDA 510(k) Application Details - K083113

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K083113
Device Name	Dressing, Wound, Drug
Applicant	SMITH & NEPHEW, INC. 970 LAKE CARILLON DR. SUITE 110 ST. PETERSBURG, FL 33716 US Other 510(k) Applications for this Company
Contact	TERRY MCMAHON 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	10/21/2008
Decision Date	07/22/2009
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