Title 21: Food and Drugs
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/ PART 878 - GENERAL AND PLASTIC SURGERY DEVICES
/ Subpart B - Diagnostic Devices
Subpart B - Diagnostic Devices
§ 878.1800 Speculum and accessories.
(a) Identification. A speculum is a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or illuminated and may have various accessories.
(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 § 878.9.