
SurGenTec, LLC
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ALARA Neuro Access Kit is an FDA 510(k)-cleared medical device (K190163) manufactured by SurGenTec, 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 July 15, 2019. Regulation: 8.

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