510(k) K052437

MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE by Surgical Specialties Corp — Product Code GAM

K052437 is an FDA 510(k) premarket notification submitted by Surgical Specialties Corp for the device "MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE". The FDA issued a decision of Substantially Equivalent on November 7, 2005. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. Surgical Specialties Corp has at least 10 other 510(k) clearances on record.