SHELF LIFE CHANGE OF STERILE DEVICES

SHELF LIFE CHANGE OF STERILE DEVICES is an FDA 510(k)-cleared medical device (K864090) manufactured by Utah Medical Products, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 19, 1987. Regulation: 8.