FDA 510(k) Application Details - K152533

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K152533
Device Name	Dressing, Wound, Drug
Applicant	Helsinn Healthcare SA Via Pain Scairolo 9 Lugano 6912 CH Other 510(k) Applications for this Company
Contact	Valentina Tombolini Bossi 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	09/03/2015
Decision Date	10/28/2016
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