510(k) K013274

MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE by Cp Medical — Product Code NEW

K013274 is an FDA 510(k) premarket notification submitted by Cp Medical for the device "MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE". The FDA issued a decision of Substantially Equivalent on November 16, 2001. The device falls under product code NEW (Suture, Surgical, Absorbable, Polydioxanone), a Class II device regulated under 21 CFR 878.4840. Cp Medical has at least 10 other 510(k) clearances on record.