510(k) K063680

SHARPOINT PDO (POLYDIOXANONE) SUTURES by Surgical Specialties Corp — Product Code NEW

K063680 is an FDA 510(k) premarket notification submitted by Surgical Specialties Corp for the device "SHARPOINT PDO (POLYDIOXANONE) SUTURES". The FDA issued a decision of Substantially Equivalent on May 9, 2007. 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.