
Welch Allyn, Inc.
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SIGMOIDOSCOPE, DISPOSABLE, MODEL #53125 is an FDA 510(k)-cleared medical device (K770291) manufactured by Welch Allyn, 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 February 17, 1977. Regulation: 8.