§874.5800. External nasal splint.
21 C.F.R. § 874.5800
Identification. An external nasal splint is a rigid or partially rigid device intended for use externally for immobilization of parts of the nose.
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.
Notes, amendments, and revision history
Amendments
[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]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 51 FR 40389, Nov. 6, 1986, unless otherwise noted.
Amendments
[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]