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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 F - Obstetrical and Gynecological Therapeutic Devices |
§ 884.5350 - Contraceptive diaphragm and accessories.
Latest version.
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§ 884.5350 Contraceptive diaphragm and accessories.
(a) Identification. A contraceptive diaphragm is a closely fitting membrane placed between the posterior aspect of the pubic bone and the posterior vaginal fornix. The device covers the cervix completely and is used with a spermicide to prevent pregnancy. This generic type of device may include an introducer.
(b) Classification. Class II (performance standards).