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Polyvue Distribution, Inc.
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POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR is an FDA 510(k)-cleared medical device (K080794) manufactured by Polyvue Distribution, 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 December 16, 2008. Regulation: 8.