FDA 510(k) Application Details - K040301

Device Classification Name	Catheter, Hemodialysis, Non-Implanted   More FDA Info for this Device
510(K) Number	K040301
Device Name	Catheter, Hemodialysis, Non-Implanted
Applicant	GAMBRO RENAL PRODUCTS 10810 WEST COLLINS AVE. LAKEWOOD, CO 80215 US Other 510(k) Applications for this Company
Contact	THOMAS B DOWELL 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	02/09/2004
Decision Date	11/01/2004
Decision	SESK - SUBST EQUIV - KIT
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