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Kontur Kontact Lens Co., Inc.
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KONTUR 55 SOFT LENS is an FDA 510(k)-cleared medical device (K001908) manufactured by Kontur Kontact Lens Co., 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 August 17, 2000. Regulation: 8.