510(k) K150327

Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2 by Dunamis, LLC — Product Code GAT

K150327 is an FDA 510(k) premarket notification submitted by Dunamis, LLC for the device "Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2". The FDA issued a decision of Substantially Equivalent on Jun 29, 2015. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Dunamis, LLC has 5 other 510(k) clearances on record.