510(k) K980738

PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION by Byron Medical — Product Code FRN

K980738 is an FDA 510(k) premarket notification submitted by Byron Medical for the device "PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION". The FDA issued a decision of Substantially Equivalent on June 16, 1998. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Byron Medical has at least 10 other 510(k) clearances on record.