510(k) K082097

DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE by Demetech Corp. — Product Code NEW

K082097 is an FDA 510(k) premarket notification submitted by Demetech Corp. for the device "DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE". The FDA issued a decision of Substantially Equivalent on January 8, 2010. The device falls under product code NEW (Suture, Surgical, Absorbable, Polydioxanone), a Class II device regulated under 21 CFR 878.4840. Demetech Corp. has at least 10 other 510(k) clearances on record.