FDA 510(k) Application Details - K063446

Device Classification Name	Kit, Repair, Catheter, Hemodialysis   More FDA Info for this Device
510(K) Number	K063446
Device Name	Kit, Repair, Catheter, Hemodialysis
Applicant	C.R. BARD, INC. 5425 WEST AMELIA EARHART DR. SALT LAKE CITY, UT 84116 US Other 510(k) Applications for this Company
Contact	PEGGY KEIFFER Other 510(k) Applications for this Contact
Regulation Number	876.5540   More FDA Info for this Regulation Number
Classification Product Code	NFK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/15/2006
Decision Date	12/15/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review