FDA 510(k) Application Details - K042672

Device Classification Name	Catheter, Hemodialysis, Implanted   More FDA Info for this Device
510(K) Number	K042672
Device Name	Catheter, Hemodialysis, Implanted
Applicant	CARDIOMED SUPPLIES, INC. 5 GORMLEY INDUSTRIAL AVENUE GORMLEY, ONTARIO L0H 1G0 CA Other 510(k) Applications for this Company
Contact	CHRISTIAN G DUBE 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	09/29/2004
Decision Date	03/23/2005
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