510(k) K972478

PRE-LOADED REPLACEMENT G-TUBES AND ACCESSORIES by Applied Medical Technologies — Product Code KNT

K972478 is an FDA 510(k) premarket notification submitted by Applied Medical Technologies for the device "PRE-LOADED REPLACEMENT G-TUBES AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on February 9, 1998. 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.