FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000

FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000 is an FDA 510(k)-cleared medical device (K093065) manufactured by Calibra Medical, Inc.. 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 January 19, 2010. Regulation: 8.