CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 874—EAR, NOSE, AND THROAT DEVICES > SUBPART F—Therapeutic Devices (§874.5220 to §874.5840) > 874.5800—External nasal splint.

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.

Code of Federal Regulations

[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]