REPLACE-A-TIP ADJUST. LOW TEMP.-

REPLACE-A-TIP ADJUST. LOW TEMP.- is an FDA 510(k)-cleared medical device (K841459) manufactured by Suncoast Medical Manufacturers, Inc.. 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 6, 1984. Regulation: 8.