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Title 21 → Chapter I → Subchapter H → Part 874 → Subpart E → §874.4100 |
Title 21: Food and Drugs
PART 874—EAR, NOSE, AND THROAT DEVICES
Subpart E—Surgical Devices
§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]