[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: 21CFR876.5210]

[Page 367]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES--Table of Contents
 
                     Subpart F--Therapeutic Devices
 
Sec. 876.5210  Enema kit.

    (a) Identification. An enema kit is a device intended to instill 
water or other fluids into the colon through a nozzle inserted into the 
rectum to promote evacuation of the contents of the lower colon. The 
device consists of a container for fluid connected to the nozzle either 
directly or via tubing. This device does not include the colonic 
irrigation system (Sec. 876.5220).
    (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 Sec. 876.9. The device is exempt from the 
current good manufacturing practice regulations in part 820 of this 
chapter, with the exception of Sec. 820.180 of this chapter, with 
respect to general requirements concerning records, and Sec. 820.198 of 
this chapter, with respect to complaint files.

[48 FR 53023, Nov. 23, 1963, as amended at 65 FR 2317, Jan. 14, 2000]