
Intl. Medical, Inc.
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AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVE is an FDA 510(k)-cleared medical device (K912927) manufactured by Intl. Medical, 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 September 18, 1991. Regulation: 8.