FDA 510(k) Application Details - K191759

Device Classification Name	More FDA Info for this Device
510(K) Number	K191759
Device Name	Medline Quick Switch Valve with ENFit Connector
Applicant	Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 US Other 510(k) Applications for this Company
Contact	Dinah Rincones Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/2019
Decision Date	12/04/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review