FDA 510(k) Application Details - K201514

Device Classification Name	More FDA Info for this Device
510(K) Number	K201514
Device Name	Child Face Mask
Applicant	Shandong Shengquan New Material Co., Ltd. Diaozhen Industrial Development Zone, Zhangqiu District, Jinan 250204 CN Other 510(k) Applications for this Company
Contact	Xiumei Zhang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OXZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/08/2020
Decision Date	10/10/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review