CUTALON NYLON POLYAMIDE SURGICAL SUTURE

CUTALON NYLON POLYAMIDE SURGICAL SUTURE is an FDA 510(k)-cleared medical device (K981322) manufactured by Genzyme Surgical Product (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 July 6, 1998. Regulation: 8.