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Dornier Medtech America, Inc.
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TCA 5R / 5S is an FDA 510(k)-cleared medical device (K070123) manufactured by Dornier Medtech America, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 8, 2007. Regulation: 8.