FDA 510(k) Application Details - K042858

Device Classification Name	Catheter, Hemodialysis, Implanted   More FDA Info for this Device
510(K) Number	K042858
Device Name	Catheter, Hemodialysis, Implanted
Applicant	SPIRE BIOMEDICAL, INC. ONE PATRIOTS PARK BEDFORD, MA 01730-2396 US Other 510(k) Applications for this Company
Contact	DONALD FICKETT 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	10/15/2004
Decision Date	12/03/2004
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