LANCASTER COOLING JACKET, CAT. CODE #13500/13501

LANCASTER COOLING JACKET, CAT. CODE #13500/13501 is an FDA 510(k)-cleared medical device (K913077) manufactured by Dlp, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 8, 1992. Regulation: 8.