FDA 510(k) Application Details - K162508

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K162508
Device Name	Dressing, Wound, Drug
Applicant	Exciton Technologies Inc. 10230 Jasper Ave., Suite 4147 Edmonton T5J 4P6 CA Other 510(k) Applications for this Company
Contact	Melanie Ussyk 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	09/08/2016
Decision Date	02/13/2017
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