KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY

KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY is an FDA 510(k)-cleared medical device (K001423) manufactured by Kawasumi Laboratories America, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 20, 2000. Regulation: 8.