[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: 21CFR878.1800]

[Page 395]
 
                        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 (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. 878.9.

[53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 59 
FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, 2001]

Subpart C [Reserved]