510(k) K945631

155 SCE(TM) HEMODIALYZER by Althin Medical AB an Affiliate of Baxter Intl — Product Code FJI

K945631 is an FDA 510(k) premarket notification submitted by Althin Medical AB an Affiliate of Baxter Intl for the device "155 SCE(TM) HEMODIALYZER". The FDA issued a decision of Substantially Equivalent on May 18, 1995. 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.