FDA 510(k) Application Details - K192463

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K192463
Device Name	Dressing, Wound, Drug
Applicant	Winner Medical Co., Ltd. Winner Industrial Park, No. 660 Bulong Road, Longhua District Shenzhen 518109 CN Other 510(k) Applications for this Company
Contact	Dan Wang 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	09/09/2019
Decision Date	05/14/2020
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