MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300

MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300 is an FDA 510(k)-cleared medical device (K970479) manufactured by Medtronic Minimed. 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 March 30, 1997. Regulation: 8.