
Berkeley Advanced Biomaterials, Inc.
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BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY is an FDA 510(k)-cleared medical device (K092046) 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 23, 2010. Regulation: 8.