510(k) K082241

THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751 by Dale Medical Products, Inc. — Product Code KNT

K082241 is an FDA 510(k) premarket notification submitted by Dale Medical Products, Inc. for the device "THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751". The FDA issued a decision of Substantially Equivalent on October 30, 2008. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Dale Medical Products, Inc. has at least 10 other 510(k) clearances on record.