CRYO-HIT II, MODELS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5

CRYO-HIT II, MODELS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 is an FDA 510(k)-cleared medical device (K991517) manufactured by Galil Medical , Ltd.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 26, 1999. Regulation: 8.