510(k) K120333

PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY by Gambro Renal Products — Product Code KPO

K120333 is an FDA 510(k) premarket notification submitted by Gambro Renal Products for the device "PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY". The FDA issued a decision of Substantially Equivalent on May 25, 2012. The device falls under product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)), a Class II device regulated under 21 CFR 876.5820. Gambro Renal Products has at least 10 other 510(k) clearances on record.