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Biomerix Corporation
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BIOMERIX SURGICAL MESH, MODEL: RCR-01 is an FDA 510(k)-cleared medical device (K070961) manufactured by Biomerix Corporation. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 24, 2008. Regulation: 8.