510(k) K921680

E-Z PEG by Mill-Rose Laboratory — Product Code KNT

K921680 is an FDA 510(k) premarket notification submitted by Mill-Rose Laboratory for the device "E-Z PEG". The FDA issued a decision of Substantially Equivalent (kit, denovo) on May 6, 1994. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Mill-Rose Laboratory has at least 10 other 510(k) clearances on record.