
Applied Urology, Inc.
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UROLOGICAL CATHETER AND ACCESSORIES is an FDA 510(k)-cleared medical device (K925282) manufactured by Applied Urology, 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 January 12, 1993. Regulation: 8.