SUNRISE TECHNOLOGIES MODEL 5020 PLDD KIT

SUNRISE TECHNOLOGIES MODEL 5020 PLDD KIT is an FDA 510(k)-cleared medical device (K944758) manufactured by Cardiogenes. 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 December 26, 1994. Regulation: 8.