HIgH-Flo Super26 Subcutaneous Needle Sets

HIgH-Flo Super26 Subcutaneous Needle Sets is an FDA 510(k)-cleared medical device (K180843) manufactured by Repro-Med Systems, Inc. Dba Rms Medical Products. 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 April 3, 2019. Regulation: 8.