FDA 510(k) Application Details - K171618

Device Classification Name	Catheter, Hemodialysis, Implanted   More FDA Info for this Device
510(K) Number	K171618
Device Name	Catheter, Hemodialysis, Implanted
Applicant	Medcomp (DBA Medical Components, Inc.) 1499 Delp Drive Harleysville, PA 19438 US Other 510(k) Applications for this Company
Contact	Courtney Nix Other 510(k) Applications for this Contact
Regulation Number	876.5540   More FDA Info for this Regulation Number
Classification Product Code	MSD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/02/2017
Decision Date	11/16/2017
Decision	SESK - SUBST EQUIV - KIT
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