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Code of Federal Regulations (Last Updated: April 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 884 - Obstetrical and Gynecological Devices |
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Subpart B - Obstetrical and Gynecological Diagnostic Devices |
§ 884.1300 - Uterotubal carbon dioxide insufflator and accessories.
Latest version.
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§ 884.1300 Uterotubal carbon dioxide insufflator and accessories.
(a) Identification. A uterotubal carbon dioxide insufflator and accessories is a device used to test the patency (lack of obstruction) of the fallopian tubes by pressurizing the uterus and fallopian tubes and filling them with carbon dioxide gas.
(b) Classification. Class II (performance standards).