FDA 510(k) Application Details - K083675

Device Classification Name	Catheter, Hemodialysis, Triple Lumen, Non-Implanted   More FDA Info for this Device
510(K) Number	K083675
Device Name	Catheter, Hemodialysis, Triple Lumen, Non-Implanted
Applicant	C.R. BARD, INC. 605 NORTH 5600 WEST SALT LAKE CITY, UT 84116 US Other 510(k) Applications for this Company
Contact	JESSICA AGNELLO Other 510(k) Applications for this Contact
Regulation Number	876.5540   More FDA Info for this Regulation Number
Classification Product Code	NIE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/11/2008
Decision Date	03/19/2009
Decision	SESE - SUBST EQUIV
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