Tyvek Sterilization Pouches with Chevron Seal

Tyvek Sterilization Pouches with Chevron Seal is an FDA 510(k)-cleared medical device (K170429) manufactured by Andersen Sterilizers, 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 26, 2017. Regulation: 8.