45L CORE INSUFFLATOR, MODEL F114

45L CORE INSUFFLATOR, MODEL F114 is an FDA 510(k)-cleared medical device (K063367) manufactured by W.O.M. World of Medicine AG. 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 May 22, 2007. Regulation: 8.