FDA 510(k) Application Details - K153723

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K153723
Device Name	Dressing, Wound, Drug
Applicant	Smith & Nephew Medical Limited 101 Hessle Road Hull HU3 2BN GB Other 510(k) Applications for this Company
Contact	Samantha Neilson 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	12/28/2015
Decision Date	09/14/2016
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