
Abco Dist.
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TYMPANOSTOMY TUBES (VARIOUS MODELS is an FDA 510(k)-cleared medical device (K820510) manufactured by Abco Dist.. 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 March 18, 1982. Regulation: 8.

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