I.V. START KIT, STERILE, DISPOSABLES

I.V. START KIT, STERILE, DISPOSABLES is an FDA 510(k)-cleared medical device (K863712) manufactured by Busse Hospital Disposables, 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 October 21, 1986. Regulation: 8.