FDA 510(k) Application Details - K213358

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K213358
Device Name	Mask, Surgical
Applicant	Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd 6A01, Block 1, Ahoke Plaza, Daling Community, Minzhi Street, Longhua District Shenzhen 518109 CN Other 510(k) Applications for this Company
Contact	Patty Chen 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	10/12/2021
Decision Date	03/04/2022
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