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Code of Federal Regulations (Last Updated: October 10, 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 868 - Anesthesiology Devices |
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Subpart G - Miscellaneous |
§ 868.6225 - Nose clip.
Latest version.
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§ 868.6225 Nose clip.
(a) Identification. A nose clip is a device intended to close a patient's external nares (nostrils) during diagnostic or therapeutic procedures.
(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 § 868.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
[47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38796, July 25, 2001]