KRYO ART CONTROLLED RATE FREEZER

KRYO ART CONTROLLED RATE FREEZER is an FDA 510(k)-cleared medical device (K032086) manufactured by Planer Plc. 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 18, 2004. Regulation: 8.