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Superdimension, Ltd.
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SUPERDIMENSION/BRONCHUS PREMIUM 2 is an FDA 510(k)-cleared medical device (K062315) manufactured by Superdimension, Ltd.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 7, 2006. Regulation: 8.