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Horizons Intl. Corp.
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HORIZONS PAPILLOTOME is an FDA 510(k)-cleared medical device (K002236) manufactured by Horizons Intl. 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 January 22, 2001. Regulation: 8.

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