[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: 21CFR874.4140]

[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 E--Surgical Devices
 
Sec. 874.4140  Ear, nose, and throat bur.

    (a) Identification. An ear, nose, and throat bur is a device 
consisting of an interchangeable drill bit that is intended for use in 
an ear, nose, and throat electric or pneumatic surgical drill 
(Sec. 874.4250) for incising or removing bone in the ear, nose, or 
throat area. The bur consists of a carbide cutting tip on a metal shank 
or a coating of diamond on a metal shank. The device is used in mastoid 
surgery, frontal sinus surgery, and surgery of the facial nerves.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 874.9.

[51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1122, Jan. 16, 1996; 66 
FR 38800, July 25, 2001]