510(k) K043027

MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20 by Applied Medical Technology, Inc. — Product Code KNT

K043027 is an FDA 510(k) premarket notification submitted by Applied Medical Technology, Inc. for the device "MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20". The FDA issued a decision of Substantially Equivalent (kit) on December 2, 2004. 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.