FDA 510(k) Application Details - K201691

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K201691
Device Name	Mask, Surgical
Applicant	Qiqihar Hengxin Medical Supplies, Ltd. 10th Beijiang Road in Tiefeng Industrial Park, North Shuguang Ave. Tiefeng District Qiqihar 161000 CN Other 510(k) Applications for this Company
Contact	Sihui Xiong 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	06/22/2020
Decision Date	09/17/2020
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