FDA 510(k) Application Details - K183577

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K183577
Device Name	Tubes, Gastrointestinal (And Accessories)
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	876.5980   More FDA Info for this Regulation Number
Classification Product Code	KNT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2018
Decision Date	05/04/2019
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