FDA 510(k) Application Details - K211861

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K211861
Device Name	Mask, Surgical
Applicant	Taiji Medical Supplies, Inc. 3211 Progress Drive Lincolnton, NC 28092 US Other 510(k) Applications for this Company
Contact	Katherine Giannamore 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	06/16/2021
Decision Date	07/28/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	Y
Expedited Review