FDA 510(k) Application Details - K140884

Device Classification Name	Catheter, Hemodialysis, Implanted   More FDA Info for this Device
510(K) Number	K140884
Device Name	Catheter, Hemodialysis, Implanted
Applicant	PHASE ONE MEDICAL 55 NORTHERN BLVD SUITE 200 GREAT NECK, NY 11021 US Other 510(k) Applications for this Company
Contact	ADITYA SUKTHANKAR 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	04/07/2014
Decision Date	11/26/2014
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