510(k) K123034

VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED by Unilene Sac — Product Code GAR

K123034 is an FDA 510(k) premarket notification submitted by Unilene Sac for the device "VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED". The FDA issued a decision of Substantially Equivalent on May 28, 2013. The device falls under product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide), a Class II device regulated under 21 CFR 878.5020. Unilene Sac has at least 1 other 510(k) clearance on record.