PARAGON BASAL/BOLUS ADMINISTRATION SET

PARAGON BASAL/BOLUS ADMINISTRATION SET is an FDA 510(k)-cleared medical device (K984063) manufactured by I-Flow Corp.. 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 February 8, 1999. Regulation: 8.