FDA 510(k) Application Details - K211440

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K211440
Device Name	Mask, Surgical
Applicant	American Surgical Mask Company LLC 5508 N 50th Street Suite 1000 Tampa, FL 33610 US Other 510(k) Applications for this Company
Contact	Matt Brandman 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	05/10/2021
Decision Date	06/02/2021
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	Y
Expedited Review