510(k) K962309

ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS by Althin Medical AB an Affiliate of Baxter Intl — Product Code FJI

K962309 is an FDA 510(k) premarket notification submitted by Althin Medical AB an Affiliate of Baxter Intl for the device "ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS". The FDA issued a decision of Substantially Equivalent on December 27, 1996. The device falls under product code FJI (Dialyzer, Capillary, Hollow Fiber), a Class II device regulated under 21 CFR 876.5820. Althin Medical AB an Affiliate of Baxter Intl has at least 10 other 510(k) clearances on record.