GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL

GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL is an FDA 510(k)-cleared medical device (K053202) manufactured by W.L. Gore & Associates. 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 December 6, 2005. Regulation: 8.