FDA 510(k) Application Details - K142775

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K142775
Device Name	Dressing, Wound, Drug
Applicant	Vigilenz Medical Devices 2A, LPBM 2, Taman Perindustrian Bukit Minyak Bukit Minyak 14100 MY Other 510(k) Applications for this Company
Contact	Shudipta Choudhury 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	09/26/2014
Decision Date	02/13/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review