
Tusker Medical
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TULA Tube Delivery System is an FDA 510(k)-cleared medical device (K171239) manufactured by Tusker Medical. 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 June 27, 2017. Regulation: 8.

Ansell
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