
Aesculap, Inc.
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PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE is an FDA 510(k)-cleared medical device (K980703) manufactured by Aesculap, 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 May 3, 1998. Regulation: 8.