WINNER SELF SEAL STERILIZATION POUCH

WINNER SELF SEAL STERILIZATION POUCH is an FDA 510(k)-cleared medical device (K051242) manufactured by Winner Medical (Usa), 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 December 12, 2005. Regulation: 8.