Title 21: Food and Drugs
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/ PART 874 - EAR, NOSE, AND THROAT DEVICES
/ Subpart E - Surgical Devices / § 874.4100 Epistaxis balloon.
§ 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.