510(k) K043539

DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES by Demetech Corp. — Product Code GAM

K043539 is an FDA 510(k) premarket notification submitted by Demetech Corp. for the device "DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES". The FDA issued a decision of Substantially Equivalent on April 6, 2005. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. Demetech Corp. has at least 10 other 510(k) clearances on record.