510(k) K062422

HUMERAL HEAD, MANUAL DRIVER by Vidacare Corporation — Product Code FMI

K062422 is an FDA 510(k) premarket notification submitted by Vidacare Corporation for the device "HUMERAL HEAD, MANUAL DRIVER". The FDA issued a decision of Substantially Equivalent on November 7, 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.