ATI DISP. BIOLOGICAL TEST PACK FOR ETHYLENE OXIDE

ATI DISP. BIOLOGICAL TEST PACK FOR ETHYLENE OXIDE is an FDA 510(k)-cleared medical device (K895704) manufactured by Pymah Corp., Ati Div.. 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 March 7, 1990. Regulation: 8.