21 C.F.R. § 884.5920 Vaginal insufflator.
Title 21 - Food and Drugs
(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 12684–12720, Feb. 26, 1980, as amended at 54 FR 25052, June 12, 1989; 66 FR 38809, July 25, 2001]
Title 21: Food and Drugs
PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES
Subpart F—Obstetrical and Gynecological Therapeutic Devices
§ 884.5920 Vaginal insufflator.
