510(k) K890094

EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET by Kells Medical, Inc. — Product Code KPE

K890094 is an FDA 510(k) premarket notification submitted by Kells Medical, Inc. for the device "EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET". The FDA issued a decision of Substantially Equivalent on May 24, 1989. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. Kells Medical, Inc. has at least 10 other 510(k) clearances on record.