§ 874.3880. Tympanostomy tube.
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/us/cfr/t21/s§ 874.3880·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A tympanostomy tube is a device that is intended to be implanted for ventilation or drainage of the middle ear. The device is inserted through the tympanic membrane to permit a free exchange of air between the outer ear and middle ear. A type of tympanostomy tube known as the malleous clip tube attaches to the malleous to provide middle ear ventilation. The device is made of materials such as polytetrafluoroethylene, polyethylene, silicon elastomer, or porous polyethylene.
(b)Classification. Class II.