510(k) K181582

DemeTECH DemeDIOX absorbable surgical suture by Demetech Corporation — Product Code NEW

K181582 is an FDA 510(k) premarket notification submitted by Demetech Corporation for the device "DemeTECH DemeDIOX absorbable surgical suture". The FDA issued a decision of Substantially Equivalent on August 27, 2018. The device falls under product code NEW (Suture, Surgical, Absorbable, Polydioxanone), a Class II device regulated under 21 CFR 878.4840. Demetech Corporation has at least 4 other 510(k) clearances on record.