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Code · CFR · Title 21 — Food and Drugs · Part 874 — Ear, Nose, and Throat Devices · § 874.4100

§ 874.4100. Epistaxis balloon.

69 words·~1 min read·/us/cfr/t21/s§ 874.4100

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(a)Identification. An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery.
(b)Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9. [51 FR 40389, Nov. 6, 1986, as amended at 65 FR 2316, Jan. 14, 2000]
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