510(k) K880084

GF 120M, 120H, 180M & 180H HOLLOW FIBER DIALYZERS by Gambro, Inc. — Product Code FJI

K880084 is an FDA 510(k) premarket notification submitted by Gambro, Inc. for the device "GF 120M, 120H, 180M & 180H HOLLOW FIBER DIALYZERS". The FDA issued a decision of Substantially Equivalent on February 19, 1988. The device falls under product code FJI (Dialyzer, Capillary, Hollow Fiber), a Class II device regulated under 21 CFR 876.5820. Gambro, Inc. has at least 10 other 510(k) clearances on record.