
W. L. Gore & Associates, Inc.
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GORE REVOX THYROPLASTY IMPLANT is an FDA 510(k)-cleared medical device (K983525) manufactured by W. L. Gore & Associates, Inc.. 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 December 9, 1998. Regulation: 8.

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