510(k) K023028

DEMETECH NYLON NONABSORBABLE SUTURE by Demetech Corp. — Product Code GAR

K023028 is an FDA 510(k) premarket notification submitted by Demetech Corp. for the device "DEMETECH NYLON NONABSORBABLE SUTURE". The FDA issued a decision of Substantially Equivalent on June 18, 2003. The device falls under product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide), a Class II device regulated under 21 CFR 878.5020. Demetech Corp. has at least 10 other 510(k) clearances on record.