FDA 510(k) Application Details - K231741

Device Classification Name	More FDA Info for this Device
510(K) Number	K231741
Device Name	ProGear« Surgical Mask with Oxafence«, Model AV82030
Applicant	Prestige Ameritech 7201 Iron Horse Blvd. North Richland Hills, TX 76180 US Other 510(k) Applications for this Company
Contact	Hofheinz Danica Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/14/2023
Decision Date	09/05/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review