FDA 510(k) Application Details - K211631

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K211631
Device Name	Mask, Surgical
Applicant	Macheng Thimble Technology Investment Co., Ltd Xiling 2nd Road, Douposhan Village, Macheng Economic Development Zone Huanggang 438000 CN Other 510(k) Applications for this Company
Contact	Donghong Sheng 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	05/27/2021
Decision Date	08/18/2021
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