FDA 510(k) Application Details - K023064

Device Classification Name	Disinfectant, Dialysate Delivery System   More FDA Info for this Device
510(K) Number	K023064
Device Name	Disinfectant, Dialysate Delivery System
Applicant	KRD CO., LTD ANDERSON CONSULTING INTL. 7307 GLOUCHESTER DRIVE EDINA, MN 55435 US Other 510(k) Applications for this Company
Contact	JEFFERY R SHIDEMAN Other 510(k) Applications for this Contact
Regulation Number	876.5860   More FDA Info for this Regulation Number
Classification Product Code	NII Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/16/2002
Decision Date	04/06/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review