510(k) K954043

MANAN BILIARY DRAINAGE CATHETER by Manan Medical Products, Inc. — Product Code FGE

K954043 is an FDA 510(k) premarket notification submitted by Manan Medical Products, Inc. for the device "MANAN BILIARY DRAINAGE CATHETER". The FDA issued a decision of Substantially Equivalent on March 26, 1996. 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. Manan Medical Products, Inc. has at least 10 other 510(k) clearances on record.