[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR874.3930]

[Page 353]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 874--EAR, NOSE, AND THROAT DEVICES--Table of Contents
 
                      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]