
Innovative Surgical Solutions, LLC ("Iss")
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SENTIO MMG is an FDA 510(k)-cleared medical device (K131304) manufactured by Innovative Surgical Solutions, LLC ("Iss"). This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 28, 2014. Regulation: 8.

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