510(k) K802966

I.V. ADDITIVE CAP by Baxa Corp., Sub. of Cook Group, Inc. — Product Code KPE

K802966 is an FDA 510(k) premarket notification submitted by Baxa Corp., Sub. of Cook Group, Inc. for the device "I.V. ADDITIVE CAP". The FDA issued a decision of Substantially Equivalent on January 7, 1981. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. Baxa Corp., Sub. of Cook Group, Inc. has at least 10 other 510(k) clearances on record.