510(k) K161413

Low Profile Balloon Feeding Device by Applied Medical Technology, Inc. — Product Code KNT

K161413 is an FDA 510(k) premarket notification submitted by Applied Medical Technology, Inc. for the device "Low Profile Balloon Feeding Device". The FDA issued a decision of Substantially Equivalent on February 9, 2017. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Applied Medical Technology, Inc. has at least 10 other 510(k) clearances on record.