TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 882 - NEUROLOGICAL DEVICES

subpart e - NEUROLOGICAL SURGICAL DEVICES

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).