510(k) K843392

GAUDERER GASTROSTOMY BUTTON by American V. Mueller — Product Code KNT

K843392 is an FDA 510(k) premarket notification submitted by American V. Mueller for the device "GAUDERER GASTROSTOMY BUTTON". The FDA issued a decision of Substantially Equivalent on October 11, 1984. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. American V. Mueller has at least 10 other 510(k) clearances on record.