THERMOGARD & THERMOGARD PLUS ABC

THERMOGARD & THERMOGARD PLUS ABC is an FDA 510(k)-cleared medical device (K972628) manufactured by Conmedcorp. 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 August 26, 1997. Regulation: 8.