FDA 510(k) Application Details - K240916

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K240916
Device Name	Mask, Surgical
Applicant	Xiantao Daoqi Plastic Co., Ltd. No.83, Wagou New District Pengchang Town Xiantao 433018 CN Other 510(k) Applications for this Company
Contact	Honghong Bie 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	04/03/2024
Decision Date	10/18/2024
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