
Covidien, LLC
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SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH is an FDA 510(k)-cleared medical device (K130357) manufactured by Covidien, LLC. 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 November 5, 2013. Regulation: 8.

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