PRIMO CE (BEHIND THE EAR)

PRIMO CE (BEHIND THE EAR) is an FDA 510(k)-cleared medical device (K780917) manufactured by Argosy Intl. (Usa), Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 13, 1978. Regulation: 8.