ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109

ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109 is an FDA 510(k)-cleared medical device (K033099) manufactured by Applied Diabetes Research, Incorporated. 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 October 15, 2003. Regulation: 8.