FDA 510(k) Application Details - K250082

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K250082
Device Name	Mask, Surgical
Applicant	Winner Medical Co., Ltd. Winner Industrial Park, No.660 Bulong Road, Longhua District 42nd Floor Building No 2, Huilong Business Center Shenzhen 518109 CN Other 510(k) Applications for this Company
Contact	Jiali Liu 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	01/13/2025
Decision Date	06/18/2025
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