APACERAM OSSICULAR PROSTHESIS

APACERAM OSSICULAR PROSTHESIS is an FDA 510(k)-cleared medical device (K893134) manufactured by Asahi Optical Co. C/O Rosati Associates, P.C.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 2, 1989. Regulation: 8.