510(k) K050548

CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS by Surgical Specialties Corp — Product Code GAW

K050548 is an FDA 510(k) premarket notification submitted by Surgical Specialties Corp for the device "CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS". The FDA issued a decision of Substantially Equivalent on April 1, 2005. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. Surgical Specialties Corp has at least 10 other 510(k) clearances on record.