ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES

ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES is an FDA 510(k)-cleared medical device (K051783) manufactured by Artsana S.P.A. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 3, 2005. Regulation: 8.