FDA 510(k) Application Details - K110793

Device Classification Name	Catheter, Hemodialysis, Non-Implanted   More FDA Info for this Device
510(K) Number	K110793
Device Name	Catheter, Hemodialysis, Non-Implanted
Applicant	AMECO MEDICAL INDUSTRIES 79 BROOKLINE ROAD MASON, NH 03048 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	MPB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/22/2011
Decision Date	12/16/2011
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