510(k) K051520

GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H by Gambro Renal Products — Product Code KDI

K051520 is an FDA 510(k) premarket notification submitted by Gambro Renal Products for the device "GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H". The FDA issued a decision of Substantially Equivalent on December 9, 2005. The device falls under product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System), a Class II device regulated under 21 CFR 876.5860. Gambro Renal Products has at least 10 other 510(k) clearances on record.