510(k) K884714

BILIARY DIALATOR by Primrose Medical, Inc. — Product Code FGE

K884714 is an FDA 510(k) premarket notification submitted by Primrose Medical, Inc. for the device "BILIARY DIALATOR". The FDA issued a decision of Substantially Equivalent on September 29, 1989. 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. Primrose Medical, Inc. has at least 10 other 510(k) clearances on record.