FDA 510(k) Application Details - K220512

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K220512
Device Name	Mask, Surgical
Applicant	Fomed Industries Inc. 20 Han Sha Road, Houhu District, Qianjiang City, Hubei Province, China Qianjiang 433115 CN Other 510(k) Applications for this Company
Contact	He Xing 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	02/22/2022
Decision Date	04/25/2022
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	N
Expedited Review