510(k) K811439

EXP 200 PARALLEL PLATE DIALYZER by Extracorporeal Medical Specialities, Inc. — Product Code FJG

K811439 is an FDA 510(k) premarket notification submitted by Extracorporeal Medical Specialities, Inc. for the device "EXP 200 PARALLEL PLATE DIALYZER". The FDA issued a decision of Substantially Equivalent on Jun 12, 1981. The device falls under product code FJG (Dialyzer, Parallel Flow), a Class II device regulated under 21 CFR 876.5820. Extracorporeal Medical Specialities, Inc. has 68 other 510(k) clearances on record.