510(k) K955487

GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS by Cobe Renal Care, Inc. — Product Code KDI

K955487 is an FDA 510(k) premarket notification submitted by Cobe Renal Care, Inc. for the device "GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS". The FDA issued a decision of Substantially Equivalent on April 18, 1997. 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. Cobe Renal Care, Inc. has at least 10 other 510(k) clearances on record.