
International Medical Industries, Inc.
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Tamper Evident Cap For use with ENFit Syringes is an FDA 510(k)-cleared medical device (K170672) manufactured by International Medical Industries, 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 October 5, 2017. Regulation: 8.