
Tyco Intl. (Us), Inc.
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AUTO SUTURE* SOFT THORACOPORT** OBTURATOR AND SLEEVE is an FDA 510(k)-cleared medical device (K992288) manufactured by Tyco Intl. (Us), 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 July 29, 1999. Regulation: 8.