ACUTEK'S CLEARPASSAGE

ACUTEK'S CLEARPASSAGE is an FDA 510(k)-cleared medical device (K951644) manufactured by Acutek Adhesive Specialties, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 2, 1995. Regulation: 8.