FDA 510(k) Application Details - K173675

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K173675
Device Name	Dressing, Wound, Drug
Applicant	ConvaTec Limited First Avenue, Deeside Industrial Park Deeside CH5 2NU GB Other 510(k) Applications for this Company
Contact	Justin Lovelace 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	11/30/2017
Decision Date	07/20/2018
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