510(k) K871108

GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER by Gambro, Inc. — Product Code KDI

K871108 is an FDA 510(k) premarket notification submitted by Gambro, Inc. for the device "GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER". The FDA issued a decision of Substantially Equivalent on May 15, 1987. 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.