BLASTFREEZE AND BLASTTHAW

BLASTFREEZE AND BLASTTHAW is an FDA 510(k)-cleared medical device (K031486) manufactured by Medicult A/S. 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, 2003. Regulation: 8.