FDA 510(k) Application Details - K223823

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K223823
Device Name	Mask, Surgical
Applicant	Efofex, Inc. 1300 North Dixieland Road Rogers, AR 72756 US Other 510(k) Applications for this Company
Contact	Siddhant Doshi 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	12/21/2022
Decision Date	03/27/2023
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