
Colon Therapeutics
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JIMMY JOHN III RECTAL NOZZEL, MODEL CIT is an FDA 510(k)-cleared medical device (K972455) manufactured by Colon Therapeutics. 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 September 8, 1997. Regulation: 8.