
Medtronic Xomed, Inc.
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EM SINUS DILATION SYSTEM is an FDA 510(k)-cleared medical device (K132297) manufactured by Medtronic Xomed, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 4, 2013. Regulation: 8.

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