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Carl Zeiss Surgical GmbH
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INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS is an FDA 510(k)-cleared medical device (K090584) manufactured by Carl Zeiss Surgical GmbH. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 23, 2009. Regulation: 8.