GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL

GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL is an FDA 510(k)-cleared medical device (K032865) manufactured by W. L. Gore & Associates, 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 27, 2003. Regulation: 8.