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Accufix Research Institute
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FIXATION STYLETS, MODELS 335-287 AND 335-288 is an FDA 510(k)-cleared medical device (K000366) manufactured by Accufix Research Institute. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 13, 2000. Regulation: 8.