FDA 510(k) Application Details - K151628

Device Classification Name	More FDA Info for this Device
510(K) Number	K151628
Device Name	Medline ENFit Connectors
Applicant	MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE MUNDELEIN, IL 60060 US Other 510(k) Applications for this Company
Contact	STEPHANIE BLAIR Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PIO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/17/2015
Decision Date	07/24/2015
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