FDA 510(k) Application Details - K202628

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K202628
Device Name	Mask, Surgical
Applicant	Qinghai Zhong Dao Win-win Medical Protective Equipment Co., No.36 Jingsan Road, Biological Park Xining 810000 CN Other 510(k) Applications for this Company
Contact	Zhaochu 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	09/11/2020
Decision Date	03/19/2021
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