FDA 510(k) Application Details - K220487

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K220487
Device Name	Mask, Surgical
Applicant	Hubei Mediunion Medical Products Co., Ltd. No.1 ChuangYe Road, Zhongling Industrial Zone, Pengchang Town Xiantao 433000 CN Other 510(k) Applications for this Company
Contact	Jason Sheen 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	04/26/2022
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