FDA 510(k) Application Details - K203078

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K203078
Device Name	Mask, Surgical
Applicant	HuiZhou TianChang Industrial Co., Ltd No.2 XingDe East Road, DongJiang Hi-Tech Industrial Park, ZhongKai Hi-Tech Industrial Park, Shuikou Town, Huicheng Dis Huizhou 516005 CN Other 510(k) Applications for this Company
Contact	Johnny Chan 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	10/13/2020
Decision Date	08/19/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review