510(k) K023615

GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR by Gambro Renal Products — Product Code MSF

K023615 is an FDA 510(k) premarket notification submitted by Gambro Renal Products for the device "GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR". The FDA issued a decision of Substantially Equivalent on May 6, 2003. The device falls under product code MSF (Hemodialyzer, Re-Use, High Flux), a Class II device regulated under 21 CFR 876.5860. Gambro Renal Products has at least 10 other 510(k) clearances on record.