510(k) K050777

PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907 by Conmedcorp — Product Code FGE

K050777 is an FDA 510(k) premarket notification submitted by Conmedcorp for the device "PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907". The FDA issued a decision of Substantially Equivalent on April 22, 2005. 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. Conmedcorp has at least 10 other 510(k) clearances on record.