
Intec Medical, Inc.
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AMCATH URETERAL DILATORS MODELS 7100,7110,7120 is an FDA 510(k)-cleared medical device (K894925) manufactured by Intec Medical, 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 December 12, 1989. Regulation: 8.