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Implantech Associates, Inc.
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GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X is an FDA 510(k)-cleared medical device (K052504) manufactured by Implantech 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 November 3, 2005. Regulation: 8.

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