DISETRONIC PENFINE INJECTION PEN NEEDLE

DISETRONIC PENFINE INJECTION PEN NEEDLE is an FDA 510(k)-cleared medical device (K982399) 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 August 5, 1998. Regulation: 8.