OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE

OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE is an FDA 510(k)-cleared medical device (K053494) manufactured by Fertipro NV. 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 March 22, 2006. Regulation: 8.