
Demetech Corp.
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DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES is an FDA 510(k)-cleared medical device (K043539) manufactured by Demetech 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 April 5, 2005. Regulation: 8.