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Tei Biosciences, Inc.
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XENFORM SOFT TISSUE REPAIR MATRIX is an FDA 510(k)-cleared medical device (K051190) manufactured by Tei Biosciences, Inc.. 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 June 9, 2005. Regulation: 8.