510(k) K053380

CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE by Surgical Specialties Corp — Product Code NEW

K053380 is an FDA 510(k) premarket notification submitted by Surgical Specialties Corp for the device "CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE". The FDA issued a decision of Substantially Equivalent on January 18, 2006. The device falls under product code NEW (Suture, Surgical, Absorbable, Polydioxanone), a Class II device regulated under 21 CFR 878.4840. Surgical Specialties Corp has at least 10 other 510(k) clearances on record.