Title 21: Food and Drugs
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/ PART 884 - OBSTETRICAL AND GYNECOLOGICAL DEVICES
/ Subpart F - Obstetrical and Gynecological Therapeutic Devices / § 884.5350 Contraceptive diaphragm and accessories.
§ 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).