STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS

STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS is an FDA 510(k)-cleared medical device (K981497) manufactured by Steritec Products Mfg Co, Inc.. 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 October 28, 1998. Regulation: 8.