FDA 510(k) Application Details - K213068

Device Classification Name	Apparatus, Exhaust, Surgical   More FDA Info for this Device
510(K) Number	K213068
Device Name	Apparatus, Exhaust, Surgical
Applicant	Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 US Other 510(k) Applications for this Company
Contact	Matt Clausen Other 510(k) Applications for this Contact
Regulation Number	878.5070   More FDA Info for this Regulation Number
Classification Product Code	FYD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/23/2021
Decision Date	01/03/2022
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