
E-Z-Em, Inc.
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E-Z-FLATE is an FDA 510(k)-cleared medical device (K930581) manufactured by E-Z-Em, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 30, 1994. Regulation: 8.