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 (K171144) manufactured by Medbio, 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 September 11, 2017. Regulation: 8.