EXTRA SENSORY PAK-DISPOS. ACCESS

EXTRA SENSORY PAK-DISPOS. ACCESS is an FDA 510(k)-cleared medical device (K833697) manufactured by American Surgical Co., Inc.. 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 27, 1983. Regulation: 8.