FDA 510(k) Application Details - K191355

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K191355
Device Name	Mask, Surgical
Applicant	3M Health Care 3M Center, 2510 Conway Ave., Building 275-5W-06 St. Paul, MN 55144 US Other 510(k) Applications for this Company
Contact	Angie Draper 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	05/21/2019
Decision Date	09/11/2019
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