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Prescient Surgical
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CleanCisionTM Wound Retraction and Protection System is an FDA 510(k)-cleared medical device (DEN150038) manufactured by Prescient Surgical. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 15, 2016. Regulation: 8.