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A-Med Systems, Inc.
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HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H is an FDA 510(k)-cleared medical device (K013393) manufactured by A-Med Systems, 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 November 8, 2001. Regulation: 8.