21 CFR 874.5800 — Splint, Nasal
Ear, Nose, Throat (EN) · Part 874 Subpart F—Therapeutic Devices · § 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 Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EPP | Splint, Nasal | 1 | 15 |
