[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR878.1800]

[Page 364]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 878--GENERAL AND PLASTIC SURGERY DEVICES--Table of Contents
 
                      Subpart B--Diagnostic Devices
 
Sec. 878.1800  Speculum and accessories.


    (a) Identification. A speculum is a device intended to be inserted 
into a body cavity to aid observation. It is either nonilluminated or 
illuminated and may have various accessories.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 59 
FR 63010, Dec. 7, 1994]

Subpart C  [Reserved]