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Hayes Medical, Inc.
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36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT is an FDA 510(k)-cleared medical device (K070061) manufactured by Hayes Medical, 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 January 30, 2007. Regulation: 8.