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21 C.F.R. § 874.4100   Epistaxis balloon.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 874—EAR, NOSE, AND THROAT DEVICES
Subpart E—Surgical Devices

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§ 874.4100   Epistaxis balloon.

(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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