EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.)

EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.) is an FDA 510(k)-cleared medical device (K041702) manufactured by Ibt SA. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 15, 2004. Regulation: 8.