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Boston Scientific Corporation
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WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730 is an FDA 510(k)-cleared medical device (K091510) manufactured by Boston Scientific Corporation. 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 June 25, 2009. Regulation: 8.