
Advanced Uroscience, Inc.
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MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX is an FDA 510(k)-cleared medical device (K993459) manufactured by Advanced Uroscience, 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 November 4, 1999. Regulation: 8.