510(k) K895329

600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA by Delmed, Inc. — Product Code KNT

K895329 is an FDA 510(k) premarket notification submitted by Delmed, Inc. for the device "600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA". The FDA issued a decision of Substantially Equivalent on October 2, 1990. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Delmed, Inc. has at least 10 other 510(k) clearances on record.