FLEXIBLE SILICONE GELIHORN

FLEXIBLE SILICONE GELIHORN is an FDA 510(k)-cleared medical device (K920187) manufactured by Bioteque America, 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 October 22, 1992. Regulation: 8.