SCANDINAVIAN IVF SCIENCES AB, GAMETE-100

SCANDINAVIAN IVF SCIENCES AB, GAMETE-100 is an FDA 510(k)-cleared medical device (K000626) manufactured by Vitrolife AB/Scandinavian Ivf Sciences AB. 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 May 22, 2000. Regulation: 8.