BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX

BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX is an FDA 510(k)-cleared medical device (K021835) manufactured by Brennen Medical, 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 October 16, 2002. Regulation: 8.