Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel

Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel is an FDA 510(k)-cleared medical device (K180720) manufactured by Medibio USA, 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 June 26, 2018. Regulation: 8.