
Shiley, Inc.
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SHILEY LOW PRESSURE THIN-CUFFED TRACH. is an FDA 510(k)-cleared medical device (K792222) manufactured by Shiley, 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 17, 1979. Regulation: 8.

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