FDA 510(k) Application Details - K202128

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K202128
Device Name	Mask, Surgical
Applicant	Allmed Medical Products Co., LTD No. 180 Gongyuan Road Majiadian Town Zhijiang 443200 CN Other 510(k) Applications for this Company
Contact	Vince Tian 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	07/31/2020
Decision Date	06/03/2021
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