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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: 21CFR874.5800]
See Related Information on External nasal splint. 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 F--Therapeutic Devices

Sec. 874.5800 External nasal splint.

(a)Identification. An external nasal splint is a rigid or partially rigid device intended for use externally for immobilization of parts of the nose.

(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 the limitations in 874.9.

[51 FR 40389, Nov. 9, 1986, as amended at 52 FR 32111, Aug. 25, 1987; 59 FR 63009, Dec. 7, 1994; 66 FR 38801, July 25, 2001]

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