DIAGNOSTIC DILATATION & MENSTRUAL KIT

DIAGNOSTIC DILATATION & MENSTRUAL KIT is an FDA 510(k)-cleared medical device (K840384) manufactured by Intl. Medical Technologies, Inc.. 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 April 29, 1984. Regulation: 8.