510(k) K982337

CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER by Haidylena Medical Egypt — Product Code FJI

K982337 is an FDA 510(k) premarket notification submitted by Haidylena Medical Egypt for the device "CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER". The FDA issued a decision of Substantially Equivalent on December 29, 1998. The device falls under product code FJI (Dialyzer, Capillary, Hollow Fiber), a Class II device regulated under 21 CFR 876.5820. Haidylena Medical Egypt has at least 1 other 510(k) clearance on record.