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