510(k) K072232

GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL by Gambro Renal Products, Inc. — Product Code KDI

K072232 is an FDA 510(k) premarket notification submitted by Gambro Renal Products, Inc. for the device "GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL". The FDA issued a decision of Substantially Equivalent on September 7, 2007. 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, Inc. has at least 10 other 510(k) clearances on record.