510(k) K970708

CLIRANS T-SERIES HOLLOW FIBER DIALYZERS by Terumo Medical Corp. — Product Code FJI

K970708 is an FDA 510(k) premarket notification submitted by Terumo Medical Corp. for the device "CLIRANS T-SERIES HOLLOW FIBER DIALYZERS". The FDA issued a decision of Substantially Equivalent on December 19, 1997. The device falls under product code FJI (Dialyzer, Capillary, Hollow Fiber), a Class II device regulated under 21 CFR 876.5820. Terumo Medical Corp. has at least 10 other 510(k) clearances on record.