BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE

BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE is an FDA 510(k)-cleared medical device (K934084) 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 15, 1993. Regulation: 8.