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Surgical Devices, A Global Business Unit Tyco
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AUTOSUTURE EEA ORVIL is an FDA 510(k)-cleared medical device (K093402) manufactured by Surgical Devices, A Global Business Unit Tyco. 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 November 11, 2009. Regulation: 8.