OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS

OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS is an FDA 510(k)-cleared medical device (K911110) manufactured by G.W.B. Intl., Ltd.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 17, 1991. Regulation: 8.