510(k) K052253

MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS by Gambro Renal Products — Product Code KPO

K052253 is an FDA 510(k) premarket notification submitted by Gambro Renal Products for the device "MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS". The FDA issued a decision of Substantially Equivalent on November 2, 2005. 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.