510(k) K760781

TRIEX-1 HOLLOW FIBER DIALYZER by Extracorporeal Medical Specialities, Inc. — Product Code FJT

K760781 is an FDA 510(k) premarket notification submitted by Extracorporeal Medical Specialities, Inc. for the device "TRIEX-1 HOLLOW FIBER DIALYZER". The FDA issued a decision of Substantially Equivalent on December 6, 1976. The device falls under product code FJT (Intracatheter, Dialysis), a Class II device regulated under 21 CFR 876.5820. Extracorporeal Medical Specialities, Inc. has at least 10 other 510(k) clearances on record.