510(k) K965162

LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P. by Lukens Medical Corp. — Product Code GAM

K965162 is an FDA 510(k) premarket notification submitted by Lukens Medical Corp. for the device "LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P.". The FDA issued a decision of Substantially Equivalent on February 12, 1997. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. Lukens Medical Corp. has at least 7 other 510(k) clearances on record.