QUILTONE MODEL 48 PP-AGC-I-D-BEHIND THE EAR

QUILTONE MODEL 48 PP-AGC-I-D-BEHIND THE EAR is an FDA 510(k)-cleared medical device (K912153) manufactured by Qualitone. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 16, 1991. Regulation: 8.