About This 510(k) Submission
K130083 is an FDA 510(k) clearance for the DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE, a Suture, Absorbable, Synthetic, Polyglycolic Acid (Class II — Special Controls, product code GAM), submitted by Demetech Corp. (Miami Lakes, US). The FDA issued a Cleared decision on July 17, 2013, 184 days after receiving the submission on January 14, 2013. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4493.