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Perry Baromedical Corp.
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SIGMA SERIES HYPERBARIC CHAMBER is an FDA 510(k)-cleared medical device (K072427) manufactured by Perry Baromedical Corp.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 10, 2008. Regulation: 8.