510(k) K201286

0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch by Nurse Assist, LLC — Product Code NGT

K201286 is an FDA 510(k) premarket notification submitted by Nurse Assist, LLC for the device "0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch". The FDA issued a decision of Substantially Equivalent on August 11, 2020. The device falls under product code NGT (Saline, Vascular Access Flush), a Class II device regulated under 21 CFR 880.5200. Nurse Assist, LLC has at least 3 other 510(k) clearances on record.