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American Biocurve, Inc.
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BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR & BLUE VISIBILITY TINT, LATHE is an FDA 510(k)-cleared medical device (K001585) manufactured by American Biocurve, 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 February 12, 2001. Regulation: 8.
