ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM

ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM is an FDA 510(k)-cleared medical device (K080838) manufactured by Alveolus, 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 April 23, 2008. Regulation: 8.