[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR874.4350]

[Page 370]
 
                        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. 874.4350  Ear, nose, and throat fiberoptic light source and carrier.

    (a) Identification. An ear, nose, and throat fiberoptic light source 
and carrier is an AC-powered device that generates and transmits light 
through glass of plastic fibers and that is intended to provide 
illumination at the tip of an ear, nose, or throat endoscope. Endoscopic 
devices which utilize fiberoptic light sources and carriers include the 
bronchoscope, esophagoscope, laryngoscope, mediastinoscope, laryngeal-
bronchial telescope, and nasopharyngoscope.
    (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 38801, July 25, 2001]

[[Page 371]]