
Tiara Medical Systems, Inc.
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ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520, TMS 2530 is an FDA 510(k)-cleared medical device (K012207) manufactured by Tiara Medical Systems, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 22, 2001. Regulation: 8.