FLUOROTEX II SURGICAL MESH

FLUOROTEX II SURGICAL MESH is an FDA 510(k)-cleared medical device (K002351) manufactured by Bridger Biomed, 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 August 25, 2000. Regulation: 8.