510(k) K021732

DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT by Dideco S.P.A. — Product Code KDI

K021732 is an FDA 510(k) premarket notification submitted by Dideco S.P.A. for the device "DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT". The FDA issued a decision of Substantially Equivalent on Nov 4, 2002. 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. Dideco S.P.A. has 32 other 510(k) clearances on record.