MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE

MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE is an FDA 510(k)-cleared medical device (K040742) manufactured by Advanced Sterilization Products. 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 April 1, 2004. Regulation: 8.