510(k) K062956

EZ-MIO, EZ-IO DISTAL TIBIA by Vidacare Corporation — Product Code FMI

K062956 is an FDA 510(k) premarket notification submitted by Vidacare Corporation for the device "EZ-MIO, EZ-IO DISTAL TIBIA". The FDA issued a decision of Substantially Equivalent on December 5, 2006. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Vidacare Corporation has at least 10 other 510(k) clearances on record.