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Berkeley Advanced Biomaterials, Inc.
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B-GENIN, R-GENIN is an FDA 510(k)-cleared medical device (K113791) manufactured by Berkeley Advanced Biomaterials, 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 March 14, 2012. Regulation: 8.