
E-Z-Em, Inc.
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EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 is an FDA 510(k)-cleared medical device (K031571) manufactured by E-Z-Em, 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 June 18, 2003. Regulation: 8.