CAREFINE PEN NEEDLE WITH QUINTAPOINT AND SUPERPOINT

CAREFINE PEN NEEDLE WITH QUINTAPOINT AND SUPERPOINT is an FDA 510(k)-cleared medical device (K140568) manufactured by Facet Technologies, LLC. 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 May 12, 2014. Regulation: 8.