510(k) K911459

GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING by Fresenius USA, Inc. — Product Code KPO

K911459 is an FDA 510(k) premarket notification submitted by Fresenius USA, Inc. for the device "GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING". The FDA issued a decision of Substantially Equivalent on July 17, 1991. The device falls under product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)), a Class II device regulated under 21 CFR 876.5820. Fresenius USA, Inc. has at least 10 other 510(k) clearances on record.