SECURE-WRAP (TM) STERILIZATION WRAP

SECURE-WRAP (TM) STERILIZATION WRAP is an FDA 510(k)-cleared medical device (K971483) manufactured by American Threshold Industries, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 23, 1997. Regulation: 8.