510(k) K062090

PRISMA SYSTEM R03.10A by Gambro Renal Products — Product Code KDI

K062090 is an FDA 510(k) premarket notification submitted by Gambro Renal Products for the device "PRISMA SYSTEM R03.10A". The FDA issued a decision of Substantially Equivalent on October 18, 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.