
Sutura, Inc.
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SUPERSTITCH 5F, 12F, AND EL is an FDA 510(k)-cleared medical device (K062125) manufactured by Sutura, 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 October 18, 2006. Regulation: 8.