510(k) K834413

DILATION BALLOON CATHETER by Hobbs Medical, Inc. — Product Code FGE

K834413 is an FDA 510(k) premarket notification submitted by Hobbs Medical, Inc. for the device "DILATION BALLOON CATHETER". The FDA issued a decision of Substantially Equivalent on May 22, 1984. 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. Hobbs Medical, Inc. has at least 10 other 510(k) clearances on record.