510(k) K890111

GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER by Gambro, Inc. — Product Code FJI

K890111 is an FDA 510(k) premarket notification submitted by Gambro, Inc. for the device "GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER". The FDA issued a decision of Substantially Equivalent on February 8, 1989. 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.