
CooperVision, Inc.
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FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS is an FDA 510(k)-cleared medical device (K042824) manufactured by CooperVision, 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 15, 2004. Regulation: 8.