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Mle, Inc.
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SUTURE FIXATION DEVICE; MESH FIXATION DEVICE is an FDA 510(k)-cleared medical device (K021834) manufactured by Mle, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 27, 2002. Regulation: 8.