DERMGARD SYSTEM 800 AND 900

DERMGARD SYSTEM 800 AND 900 is an FDA 510(k)-cleared medical device (K880486) manufactured by Dermgard, Inc.. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 21, 1988. Regulation: 8.