TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004

TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004 is an FDA 510(k)-cleared medical device (K031225) manufactured by Gfe Medizintechnik GmbH. 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 September 28, 2003. Regulation: 8.