[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR884.1300]

[Page 421]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES--Table of Contents
 
       Subpart B--Obstetrical and Gynecological Diagnostic Devices
 
Sec. 884.1300  Uterotubal carbon dioxide insufflator and accessories.

    (a) Identification. A uterotubal carbon dioxide insufflator and 
accessories is a device used to test the patency (lack of obstruction) 
of the fallopian tubes by pressurizing the uterus and fallopian tubes 
and filling them with carbon dioxide gas.
    (b) Classification. Class II (performance standards).