SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH

SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH is an FDA 510(k)-cleared medical device (K053066) manufactured by Genzyme Corporation. 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 18, 2005. Regulation: 8.