510(k) K933818

GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER by C.G.H. Medical, Inc. — Product Code KDI

K933818 is an FDA 510(k) premarket notification submitted by C.G.H. Medical, Inc. for the device "GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER". The FDA issued a decision of Substantially Equivalent on January 25, 1995. 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. C.G.H. Medical, Inc. has at least 10 other 510(k) clearances on record.