Code of Federal Regulations (Last Updated: February 15, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter H - Medical Devices |
Part 884 - Obstetrical and Gynecological Devices |
Subpart F - Obstetrical and Gynecological Therapeutic Devices |
§ 884.5920 - Vaginal insufflator.
Latest version.
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§ 884.5920 Vaginal insufflator.
(a) Identification. A vaginal insufflator is a device used to treat vaginitis by introducing medicated powder from a hand-held bulb into the vagina through an open speculum.
(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
[45 FR 12684, Feb. 26, 1980, as amended at 54 FR 25052, June 12, 1989; 66 FR 38809, July 25, 2001]