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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.”
Code of Federal Regulations
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