510(k) K811292

PARALLEL PLATE DIALYZER HOLDER by Extracorporeal Medical Specialities, Inc. — Product Code FKI

K811292 is an FDA 510(k) premarket notification submitted by Extracorporeal Medical Specialities, Inc. for the device "PARALLEL PLATE DIALYZER HOLDER". The FDA issued a decision of Substantially Equivalent on June 2, 1981. The device falls under product code FKI (Set, Dialyzer Holder), a Class II device regulated under 21 CFR 876.5820. Extracorporeal Medical Specialities, Inc. has at least 10 other 510(k) clearances on record.