
Smithkline Diagnostics, Inc.
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SIGMOIDOSCOPE/ DISPOSABLE is an FDA 510(k)-cleared medical device (K761180) manufactured by Smithkline Diagnostics, 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 4, 1977. Regulation: 8.