MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385

MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385 is an FDA 510(k)-cleared medical device (K010377) manufactured by Minimed, 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 April 4, 2001. Regulation: 8.