510(k) K193101

Omnifix Low Dead Space Luer Lock Syringe by B.Braun Medical, Inc. — Product Code FMF

K193101 is an FDA 510(k) premarket notification submitted by B.Braun Medical, Inc. for the device "Omnifix Low Dead Space Luer Lock Syringe". The FDA issued a decision of Substantially Equivalent on Mar 5, 2020. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. B.Braun Medical, Inc. has 149 other 510(k) clearances on record.