HI-TECH LAB MODEL CONCHA ALL IN EAR

HI-TECH LAB MODEL CONCHA ALL IN EAR is an FDA 510(k)-cleared medical device (K853967) manufactured by Hi-Tech Laboratories, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 26, 1985. Regulation: 8.