[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: 21CFR876.5470]

[Page 355]
 
                        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. 876.5470  Ureteral dilator.

    (a) Identification. A ureteral dilator is a device that consists of 
a specially shaped catheter or bougie and is used to dilate the ureter 
at the place where a stone has become lodged or to dilate a ureteral 
stricture.
    (b) Classification. Class II (performance standards).

[[Page 356]]