OCU-GUARD AND OCU-GUARD SUPPLE

OCU-GUARD AND OCU-GUARD SUPPLE is an FDA 510(k)-cleared medical device (K983581) manufactured by Bio-Vascular, 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 November 5, 1998. Regulation: 8.