FDA 510(k) Application Details - K213347

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K213347
Device Name	Mask, Surgical
Applicant	Asia Dynamics Inc., d/b/a ADI Medical 1565 South Shields Drive Waukegan, IL 60085 US Other 510(k) Applications for this Company
Contact	Jonathan Zhu 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	10/08/2021
Decision Date	01/25/2022
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