FDA 510(k) Application Details - K201625

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K201625
Device Name	Mask, Surgical
Applicant	Tianjin Saiyuan Technology CO., LTD 8 DongJiu Street, Zhongxin Road, Pilot Free Trade Zone (Airport Economic Area) Tianjin 300308 CN Other 510(k) Applications for this Company
Contact	Hong Cai 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	06/15/2020
Decision Date	01/12/2021
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