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Eupalamus, LLC
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EUPALAMUS DEFLECTABLE STYLET, MODEL 01545 is an FDA 510(k)-cleared medical device (K002534) manufactured by Eupalamus, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 17, 2000. Regulation: 8.