510(k) K010672

MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE by Gramsmed, LLC — Product Code GAM

K010672 is an FDA 510(k) premarket notification submitted by Gramsmed, LLC for the device "MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE". The FDA issued a decision of Substantially Equivalent on May 18, 2001. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. Gramsmed, LLC has at least 6 other 510(k) clearances on record.