
Princeton Regulatory Assoc.
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UROSURGE ACUTRAINER is an FDA 510(k)-cleared medical device (K962770) manufactured by Princeton Regulatory Assoc.. 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 July 31, 1996. Regulation: 8.