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Code of Federal Regulations (Last Updated: May 6, 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 880 - General Hospital and Personal Use Devices |
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Subpart F - General Hospital and Personal Use Therapeutic Devices |
§ 880.5950 - Umbilical occlusion device.
Latest version.
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§ 880.5950 Umbilical occlusion device.
(a) Identification. An umbilical occlusion device is a clip, tie, tape, or other article used to close the blood vessels in the umbilical cord of a newborn infant.
(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.
[45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38805, July 25, 2001]