
Medical Engineering Corp.
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SURGITEK (R) UROFLOW SYSTEM is an FDA 510(k)-cleared medical device (K883274) manufactured by Medical Engineering 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 February 7, 1989. Regulation: 8.