FLUORO-TEX SURGICAL MEMBRANE

FLUORO-TEX SURGICAL MEMBRANE is an FDA 510(k)-cleared medical device (K973178) manufactured by Bridger Biomed, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 23, 1997. Regulation: 8.