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Menicon Co, Ltd.
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MENICON Z RIGID GAS PERMEABLE CONTACT LENS is an FDA 510(k)-cleared medical device (K081443) manufactured by Menicon Co, 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 September 22, 2008. Regulation: 8.