ATI ETHYLENE OXIDE STERILIZATION INDICATOR

ATI ETHYLENE OXIDE STERILIZATION INDICATOR is an FDA 510(k)-cleared medical device (K952995) manufactured by Pymah Corp.. 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 21, 1996. Regulation: 8.