510(k) K063567

EZ-MIO STERNAL by Vidacare Corporation — Product Code FMI

K063567 is an FDA 510(k) premarket notification submitted by Vidacare Corporation for the device "EZ-MIO STERNAL". The FDA issued a decision of Substantially Equivalent on January 26, 2007. 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.