(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]