FDA 510(k) Application Details - K210815

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K210815
Device Name	Mask, Surgical
Applicant	Biobase Scientific (Shandong) Co., Ltd. No.1777 Dazheng Road, High-Tech District, Jinan City, Shandong Province, China Jinan 250000 CN Other 510(k) Applications for this Company
Contact	Qingxiang Hou 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	03/18/2021
Decision Date	05/13/2021
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