510(k) K112863

ENTERAL ADMINISTRATION SET WITH SOLUTION CONTAINER, ENTERAL ADMINISTRATION SET, ENTERAL EXTENSION SET WITH MINITUBE CONN by Acta Medical, LLC — Product Code KNT

K112863 is an FDA 510(k) premarket notification submitted by Acta Medical, LLC for the device "ENTERAL ADMINISTRATION SET WITH SOLUTION CONTAINER, ENTERAL ADMINISTRATION SET, ENTERAL EXTENSION SET WITH MINITUBE CONN". The FDA issued a decision of Substantially Equivalent on March 29, 2012. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Acta Medical, LLC has at least 2 other 510(k) clearances on record.