510(k) K872458

AN3200 DOUBILET DRAIN by H.W. Andersen Products, Inc. — Product Code FGE

K872458 is an FDA 510(k) premarket notification submitted by H.W. Andersen Products, Inc. for the device "AN3200 DOUBILET DRAIN". The FDA issued a decision of Substantially Equivalent on September 21, 1987. The device falls under product code FGE (Stents, Drains And Dilators For The Biliary Ducts), a Class II device regulated under 21 CFR 876.5010. H.W. Andersen Products, Inc. has at least 4 other 510(k) clearances on record.