510(k) K850654

TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID by Erika, Inc. — Product Code FJI

K850654 is an FDA 510(k) premarket notification submitted by Erika, Inc. for the device "TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID". The FDA issued a decision of Substantially Equivalent on March 7, 1985. The device falls under product code FJI (Dialyzer, Capillary, Hollow Fiber), a Class II device regulated under 21 CFR 876.5820. Erika, Inc. has at least 10 other 510(k) clearances on record.