510(k) K850655

TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2 by Erika, Inc. — Product Code FJI

K850655 is an FDA 510(k) premarket notification submitted by Erika, Inc. for the device "TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2". 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.