CFR
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880.6320—AC-powered medical examination light.
(a) Identification.
An AC-powered medical examination light is an AC-powered device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination.
(b) Classification.
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.
Code of Federal Regulations
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