FDA 510(k) Application Details - K202277

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K202277
Device Name	Mask, Surgical
Applicant	Jiangxi 3L Medical Products Group Co., Ltd No.599, Huoju Street, High-tech Development Zone Nanchang City 330029 CN Other 510(k) Applications for this Company
Contact	Ge Zhang 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	08/11/2020
Decision Date	09/25/2020
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