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Paragon Vision Sciences
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FLUOROPERM 151-OK, PARAGON HDS 100-OK is an FDA 510(k)-cleared medical device (K010109) manufactured by Paragon Vision Sciences. 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 27, 2001. Regulation: 8.