510(k) K963933

PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER by Baxter Healthcare Corp — Product Code FJI

K963933 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER". The FDA issued a decision of Substantially Equivalent on November 24, 1997. The device falls under product code FJI (Dialyzer, Capillary, Hollow Fiber), a Class II device regulated under 21 CFR 876.5820. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.