FDA 510(k) Application Details - K173005

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K173005
Device Name	Dressing, Wound, Drug
Applicant	Jiangsu Newvalue Medical Producst Co.,Ltd Building G35.the east of KouTai Road and the north of Xin Yang Road.CMC. TaiZhou 225300 CN Other 510(k) Applications for this Company
Contact	Julie Chen 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	09/27/2017
Decision Date	05/25/2018
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