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Merit Medical Systems, Inc.
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ENDOMAXX FULLY COVERED ESOPHAGEAL STENT is an FDA 510(k)-cleared medical device (K111611) manufactured by Merit Medical Systems, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 28, 2011. Regulation: 8.