Regulation Text
(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 .
Authority
21 U.S.C. 351,360,360c,360e,360j,360l,371.