
Kinetic Concepts, Inc.
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TRACH-COLLAR is an FDA 510(k)-cleared medical device (K782002) manufactured by Kinetic Concepts, 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 14, 1978. Regulation: 8.

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