510(k) K990808

PBN DILATORS by Medical Device Technologies, Inc. — Product Code FGE

K990808 is an FDA 510(k) premarket notification submitted by Medical Device Technologies, Inc. for the device "PBN DILATORS". The FDA issued a decision of Substantially Equivalent on November 26, 1999. 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. Medical Device Technologies, Inc. has at least 10 other 510(k) clearances on record.