FDA 510(k) Application Details - K070572

Device Classification Name	Catheter, Hemodialysis, Implanted   More FDA Info for this Device
510(K) Number	K070572
Device Name	Catheter, Hemodialysis, Implanted
Applicant	ASH ACCESS TECHNOLOGY, INC. 3601 SAGAMORE PKWY N SUITE B LAFAYETTE, IN 47904 US Other 510(k) Applications for this Company
Contact	ROLAND WINGER 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	02/28/2007
Decision Date	06/26/2007
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