ATI-PYMAH DISPOSABLE STEAM BIOLOGICAL TEST PACK

ATI-PYMAH DISPOSABLE STEAM BIOLOGICAL TEST PACK is an FDA 510(k)-cleared medical device (K884615) 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 January 18, 1989. Regulation: 8.