510(k) K090002

ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A by Baxter Healthcare Corp — Product Code KPO

K090002 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A". The FDA issued a decision of Substantially Equivalent on August 7, 2009. The device falls under product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)), a Class II device regulated under 21 CFR 876.5820. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.