510(k) K922005

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

K922005 is an FDA 510(k) premarket notification submitted by Fresenius USA, Inc. for the device "GRANULYTE DIALYSATE CONCENTRATE". The FDA issued a decision of Substantially Equivalent on March 30, 1994. 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.