FDA 510(k) Application Details - K190819

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K190819
Device Name	Dressing, Wound, Drug
Applicant	Advanced Medical Solutions Ltd. Premier Park, 33 Road One, Winsford Industrial Estate Winsford CW7 3RT GB Other 510(k) Applications for this Company
Contact	Adam Gregory 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	04/01/2019
Decision Date	07/25/2019
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