§882.4250. Cryogenic surgical device.
21 C.F.R. § 882.4250
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.
Classification. Class II (performance standards).
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.