510(k) K032431

PRISMA M60/M100 SETS by Gambro, Inc. — Product Code KDI

K032431 is an FDA 510(k) premarket notification submitted by Gambro, Inc. for the device "PRISMA M60/M100 SETS". The FDA issued a decision of Substantially Equivalent on September 15, 2003. 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, Inc. has at least 10 other 510(k) clearances on record.