POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT

POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT is an FDA 510(k)-cleared medical device (K863946) manufactured by Porex Medical. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 26, 1987. Regulation: 8.