SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES

SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES is an FDA 510(k)-cleared medical device (K010710) manufactured by Seedling Enterprises., LLC. 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 May 17, 2001. Regulation: 8.