Code of Federal Regulations · Section
§ 882.4400 — Radiofrequency Lesion Generator
21 C.F.R. § 882.4400
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(a) Identification. A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.
(b) Classification. Class II (performance standards).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351