
Richard Wolf Medical Instruments Corp.
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URS-HYDRO-DILATOR MODEL NUMBER 2164.00 is an FDA 510(k)-cleared medical device (K912331) manufactured by Richard Wolf Medical Instruments Corp.. 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 29, 1991. Regulation: 8.