CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR874.3930]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 874 -- EAR, NOSE, AND THROAT DEVICES

Subpart D - Prosthetic Devices

Sec. 874.3930 Tympanostomy tube with semipermeable membrane.

(a) Identification. A tympanostomy tube with a semipermeable membrane is a device intended to be implanted for ventilation or drainage of the middle ear and for preventing fluids from entering the middle ear cavity. The device is inserted through the tympanic membrane to permit a free exchange of air between the outer ear and middle ear. The tube portion of the device is made of silicone elastomer or porous polyethylene, and the membrane portion is made of polytetrafluoroethylene.

(b) Classification. Class II. The special control for this device is FDA's "Tympanostomy Tubes, Submission Guidance for a 510(k)."

[51 FR 40389, Nov. 6, 1986, as amended at 65 FR 17145, Mar. 31, 2000]