Code of Federal Regulations · Section
§ 882.4250 — Cryogenic Surgical Device
21 C.F.R. § 882.4250
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(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).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351