
Sandhill Scientific, Inc.
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INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300 is an FDA 510(k)-cleared medical device (K990441) manufactured by Sandhill Scientific, 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 May 11, 1999. Regulation: 8.