SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1

SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1 is an FDA 510(k)-cleared medical device (K000618) 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 16, 2000. Regulation: 8.