510(k) K060195

GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE by Gambro Renal Products — Product Code KDI

K060195 is an FDA 510(k) premarket notification submitted by Gambro Renal Products for the device "GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE". The FDA issued a decision of Substantially Equivalent on April 24, 2006. 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.