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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR874.4100]
See Related Information on Epistaxis balloon. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 874 -- EAR, NOSE, AND THROAT DEVICES

Subpart E--Surgical Devices

Sec. 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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