FDA 510(k) Application Details - K191378

Device Classification Name	Saline, Vascular Access Flush   More FDA Info for this Device
510(K) Number	K191378
Device Name	Saline, Vascular Access Flush
Applicant	Medline Industries, Inc. Three Lake Drive Northfield, IL 60093 US Other 510(k) Applications for this Company
Contact	Stephanie Augsburg Other 510(k) Applications for this Contact
Regulation Number	880.5200   More FDA Info for this Regulation Number
Classification Product Code	NGT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/23/2019
Decision Date	09/15/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review