510(k) K955592

COBE CENTRYSYSTEM 14 PES HEMODIALYZERS by Cobe Renal Care, Inc. — Product Code KDI

K955592 is an FDA 510(k) premarket notification submitted by Cobe Renal Care, Inc. for the device "COBE CENTRYSYSTEM 14 PES HEMODIALYZERS". The FDA issued a decision of Substantially Equivalent on April 30, 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.