VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT

VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT is an FDA 510(k)-cleared medical device (K060168) manufactured by Irvine Scientific Sales Co., Inc.. 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 April 23, 2006. Regulation: 8.