TITAN AIR SPECTACLE FRAME

TITAN AIR SPECTACLE FRAME is an FDA 510(k)-cleared medical device (K896350) manufactured by Acces Intl. Eyewear. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 17, 1989. Regulation: 8.