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Contamac, Ltd.
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OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES is an FDA 510(k)-cleared medical device (K033594) manufactured by Contamac, 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 March 18, 2004. Regulation: 8.