
Convatec, A Division of E.R. Squibb & Sons
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FLEXI-TRAK(TM) ANCHORING DEVICE is an FDA 510(k)-cleared medical device (K905128) manufactured by Convatec, A Division of E.R. Squibb & Sons. 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 November 28, 1990. Regulation: 8.