STERRAAD 100NX EXPRESS CYCLE TEST PACK

STERRAAD 100NX EXPRESS CYCLE TEST PACK is an FDA 510(k)-cleared medical device (K092755) 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 February 24, 2011. Regulation: 8.