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B. Braun Avitum AG
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SOLCART B is an FDA 510(k)-cleared medical device (K102194) manufactured by B. Braun Avitum AG. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 24, 2011. Regulation: 8.

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