
Rastronics USA, Inc.
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RASTRONICS CCI 8 is an FDA 510(k)-cleared medical device (K902244) manufactured by Rastronics USA, 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 October 4, 1990. Regulation: 8.

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