KBI — Bougie, Eustachian Class I
FDA product code KBI covers "Bougie, Eustachian", a Class I medical device regulated under 21 CFR 874.4175. Submissions are reviewed by the Ear, Nose, Throat panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- KBI
- Device Class
- Class I
- Regulation Number
- 874.4175
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K770959 | v. mueller o.v. baxter healthcare | BOUGIE, FILIFORM, JACKSON | June 14, 1977 |