FDA 510(k) Application Details - K955423

Device Classification Name	System, Dialysate Delivery, Single Patient   More FDA Info for this Device
510(K) Number	K955423
Device Name	System, Dialysate Delivery, Single Patient
Applicant	FRESENIUS USA, INC. 2637 SHADELANDS DR. WALNUT CREEK, CA 94598 US Other 510(k) Applications for this Company
Contact	TOM FOLDEN 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	11/28/1995
Decision Date	06/13/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review