MALE REMEEX SYSTEM

MALE REMEEX SYSTEM is an FDA 510(k)-cleared medical device (K062341) manufactured by Specialities Remeex International, S.L.. 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 November 1, 2006. Regulation: 8.