BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIE

BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIE is an FDA 510(k)-cleared medical device (K924753) manufactured by Bioenterics Corp.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 14, 1992. Regulation: 8.