FDA 510(k) Application Details - K021060

Device Classification Name	System, Dialysate Delivery, Single Patient   More FDA Info for this Device
510(K) Number	K021060
Device Name	System, Dialysate Delivery, Single Patient
Applicant	FRESENIUS MEDICAL CARE NORTH AMERICA 95 HAYDEN AVE. LEXINGTON, MA 02420-9192 US Other 510(k) Applications for this Company
Contact	NICHOLE RIEK Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	FKP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/02/2002
Decision Date	11/13/2002
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