PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS

PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS is an FDA 510(k)-cleared medical device (K964245) manufactured by Starkey 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 February 3, 1997. Regulation: 8.