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Coapt Systems, Inc.
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ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE is an FDA 510(k)-cleared medical device (K042796) manufactured by Coapt Systems, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 4, 2004. Regulation: 8.