510(k) K082863

DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML) by Dynarex Corporation — Product Code KNT

K082863 is an FDA 510(k) premarket notification submitted by Dynarex Corporation for the device "DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML)". The FDA issued a decision of Substantially Equivalent on January 9, 2009. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Dynarex Corporation has at least 7 other 510(k) clearances on record.