MODEL 8100 PRE-FILLED INTRAUTERINE

MODEL 8100 PRE-FILLED INTRAUTERINE is an FDA 510(k)-cleared medical device (K790418) manufactured by Ge Medical Systems Information Technologies. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 20, 1979. Regulation: 8.