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Novalung GmbH
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NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG is an FDA 510(k)-cleared medical device (K072362) manufactured by Novalung GmbH. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 22, 2007. Regulation: 8.