510(k) K951352

DEXON S, DEXON PLUS, AND DEXON II POLYGLYCOLIC ACID SUTURE by Davis & Geck, Inc. — Product Code GAM

K951352 is an FDA 510(k) premarket notification submitted by Davis & Geck, Inc. for the device "DEXON S, DEXON PLUS, AND DEXON II POLYGLYCOLIC ACID SUTURE". The FDA issued a decision of Substantially Equivalent on June 5, 1995. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. Davis & Geck, Inc. has at least 10 other 510(k) clearances on record.