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Code · CFR · Title 21 — Food and Drugs · Part 884 — Obstetrical and Gynecological Devices · § 884.5920

§ 884.5920. Vaginal insufflator.

77 words·~1 min read·/us/cfr/t21/s§ 884.5920·

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(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]
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