FLEBOSET 1401(60 DROPS/MI) AND FLEBOSET1400(20)

FLEBOSET 1401(60 DROPS/MI) AND FLEBOSET1400(20) is an FDA 510(k)-cleared medical device (K852606) manufactured by Infarkem 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 September 18, 1985. Regulation: 8.