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Vitrolife AB/Scandinavian Ivf Sciences AB
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SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1 is an FDA 510(k)-cleared medical device (K000623) 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 15, 2000. Regulation: 8.

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