GRAMSORB SYNTHETIC ABSORBABLE SUTURE

GRAMSORB SYNTHETIC ABSORBABLE SUTURE is an FDA 510(k)-cleared medical device (K003017) manufactured by Gramsmed, LLC. 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 12, 2001. Regulation: 8.