510(k) K072028

QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM by Surgical Specialties Corp — Product Code GAM

K072028 is an FDA 510(k) premarket notification submitted by Surgical Specialties Corp for the device "QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM". The FDA issued a decision of Substantially Equivalent on August 3, 2007. 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.