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Poly Vue Technolgies, Inc.
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HD/HDT, PV/PVT (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS) is an FDA 510(k)-cleared medical device (K013220) manufactured by Poly Vue Technolgies, 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 19, 2001. Regulation: 8.