Code of Federal Regulations · Section
§ 886.4100 — Radiofrequency Electrosurgical Cautery Apparatus
21 C.F.R. § 886.4100
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(a) Identification. A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by a high frequency electric current.
(b) Classification. Class II.
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351