§ 878.4580. Surgical lamp.
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/us/cfr/t21/s§ 878.4580·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.
(b)Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. [53 FR 23872, June 24, 1988, as amended at 84 FR 71814, Dec. 30, 2019]
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§ 878.4580
Surgical lamp.
Fed. Reg.×1
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