FDA 510(k) Application Details - K221038

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K221038
Device Name	Mask, Surgical
Applicant	Hantech Medical Device Co., Ltd. No 288, Sanheng Road Changhe Industridal Park, Cixi Ningbo 315326 CN Other 510(k) Applications for this Company
Contact	Arnold Yang 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	04/07/2022
Decision Date	09/01/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review