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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 874 - EAR, Nose, and Throat Devices |
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Subpart F - Therapeutic Devices |
§ 874.5800 - External nasal splint.
Latest version.
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§ 874.5800 External nasal splint.
(a) Identification. An external nasal splint is a rigid or partially rigid device intended for use externally for immobilization of parts of the nose.
(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 § 874.9.
[51 FR 40389, Nov. 9, 1986, as amended at 52 FR 32111, Aug. 25, 1987; 59 FR 63009, Dec. 7, 1994; 66 FR 38801, July 25, 2001]