510(k) K892523

GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY by Gambro, Inc. — Product Code FJI

K892523 is an FDA 510(k) premarket notification submitted by Gambro, Inc. for the device "GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY". The FDA issued a decision of Substantially Equivalent on May 11, 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.