510(k) K061197

KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER by Kawasumi Laboratories, Inc. — Product Code KPE

K061197 is an FDA 510(k) premarket notification submitted by Kawasumi Laboratories, Inc. for the device "KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER". The FDA issued a decision of Substantially Equivalent on June 30, 2006. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. Kawasumi Laboratories, Inc. has at least 10 other 510(k) clearances on record.