510(k) K944937

SYNTHETIC ABSORBABLE SUTURE by Johnson & Johnson International — Product Code GAM

K944937 is an FDA 510(k) premarket notification submitted by Johnson & Johnson International for the device "SYNTHETIC ABSORBABLE SUTURE". The FDA issued a decision of Substantially Equivalent on May 19, 1995. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. Johnson & Johnson International has at least 9 other 510(k) clearances on record.