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Maquet Cardiopulmonary, AG
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JOSTRA QUADROX D SAFELINE DIFFUSION MEMBRANE OXYGENATOR, MODEL HMOD 2030 is an FDA 510(k)-cleared medical device (K061628) manufactured by Maquet Cardiopulmonary, AG. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 21, 2006. Regulation: 8.