Title 21: Food and Drugs
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/ PART 884 - OBSTETRICAL AND GYNECOLOGICAL DEVICES
/ Subpart F - Obstetrical and Gynecological Therapeutic Devices / § 884.5970 Clitoral engorgement device.
§ 884.5970 Clitoral engorgement device.
(a) Identification. A clitoral engorgement device is designed to apply a vacuum to the clitoris. It is intended for use in the treatment of female sexual arousal disorder.
(b) Classification. Class II (special controls). The special control is a guidance document entitled: “Guidance for Industry and FDA Reviewers: Class II Special Controls Guidance Document for Clitoral Engorgement Devices.”