
Medi-Tech, Inc.
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T-FASTENER is an FDA 510(k)-cleared medical device (K861599) manufactured by Medi-Tech, 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 October 1, 1986. Regulation: 8.