510(k) K080985

QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO) by Surgical Specialties Corp — Product Code NEW

K080985 is an FDA 510(k) premarket notification submitted by Surgical Specialties Corp for the device "QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO)". The FDA issued a decision of Substantially Equivalent on Apr 23, 2008. The device falls under product code NEW (Suture, Surgical, Absorbable, Polydioxanone), a Class II device regulated under 21 CFR 878.4840. Surgical Specialties Corp has at least 10 other 510(k) clearances on record.