510(k) K961345

DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE by Applied Medical Technologies — Product Code KNT

K961345 is an FDA 510(k) premarket notification submitted by Applied Medical Technologies for the device "DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE". The FDA issued a decision of Substantially Equivalent on September 17, 1996. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Applied Medical Technologies has at least 10 other 510(k) clearances on record.