FDA 510(k) Application Details - K182515

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K182515
Device Name	Mask, Surgical
Applicant	Wuhan Dymex Healthcare Co., Ltd Room 1701, Unit 2, Building 5, Jingsegangwan Phase 5, Dongfeng Avenus Wuhan 430000 CN Other 510(k) Applications for this Company
Contact	Ada Liu Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	FXX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/12/2018
Decision Date	05/27/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review