DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE

DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE is an FDA 510(k)-cleared medical device (K013782) manufactured by Disetronic Medical Systems. 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 November 19, 2001. Regulation: 8.