FDA 510(k) Application Details - K123943

Device Classification Name	Catheter, Hemodialysis, Implanted   More FDA Info for this Device
510(K) Number	K123943
Device Name	Catheter, Hemodialysis, Implanted
Applicant	AMECO MEDICAL INDUSTRIES ARAZY GROUP 57 LAZY BROOK RD. MONROE, CT 03468 US Other 510(k) Applications for this Company
Contact	Ray Kelly 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	12/20/2012
Decision Date	04/02/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review