
Design Standards Corp.
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SURELINE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS is an FDA 510(k)-cleared medical device (K040602) manufactured by Design Standards Corp.. 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 May 9, 2004. Regulation: 8.