[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: 21CFR882.4250]

[Page 409]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 882--NEUROLOGICAL DEVICES--Table of Contents
 
                Subpart E--Neurological Surgical Devices
 
Sec. 882.4250  Cryogenic surgical device.

    (a) Identification. A cryogenic surgical device is a device used to 
destroy nervous tissue or produce lesions in nervous tissue by the 
application of extreme cold to the selected site.
    (b) Classification. Class II (performance standards).