
Diamed Division Ill. Tool Works, Inc.
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TOUCHLESS TM FOLEY CATHETER KIT is an FDA 510(k)-cleared medical device (K790728) manufactured by Diamed Division Ill. Tool Works, 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 May 31, 1979. Regulation: 8.