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Cryolife, Inc.
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CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH is an FDA 510(k)-cleared medical device (K101866) manufactured by Cryolife, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 22, 2010. Regulation: 8.