DEXTRAN SERUM SUPPLEMENT (DSS), MODEL 9301

DEXTRAN SERUM SUPPLEMENT (DSS), MODEL 9301 is an FDA 510(k)-cleared medical device (K003448) manufactured by Irvine Scientific Sales Co., Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 6, 2000. Regulation: 8.