VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING

VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING is an FDA 510(k)-cleared medical device (K140487) manufactured by STERIS Corporation. 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 July 21, 2014. Regulation: 8.