LUNETTE MENSTRUAL CUP, MODELS 1 AND 2

LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 is an FDA 510(k)-cleared medical device (K091754) manufactured by Lune Group , Ltd.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 12, 2009. Regulation: 8.