MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE

MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE is an FDA 510(k)-cleared medical device (K030212) manufactured by Genzyme Biosurgery. 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 March 26, 2003. Regulation: 8.