ELPH INJECTION SYSTEM

ELPH INJECTION SYSTEM is an FDA 510(k)-cleared medical device (K022116) manufactured by Mallinckrodt Inc., Liebel-Flarsheim Business. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 25, 2002. Regulation: 8.