SCANDINAVIAN IVF SCIENCES AB, G2.2

SCANDINAVIAN IVF SCIENCES AB, G2.2 is an FDA 510(k)-cleared medical device (K000619) 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 June 26, 2000. Regulation: 8.