510(k) K012147

DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE by Zevex, Inc. — Product Code KNT

K012147 is an FDA 510(k) premarket notification submitted by Zevex, Inc. for the device "DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE". The FDA issued a decision of Substantially Equivalent on November 2, 2001. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Zevex, Inc. has at least 4 other 510(k) clearances on record.