
Conmed Integrated Systems, Canada, Ulc
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SERVICE MANAGER SM40SE is an FDA 510(k)-cleared medical device (K053464) manufactured by Conmed Integrated Systems, Canada, Ulc. 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 June 5, 2006. Regulation: 8.