LBM — Porous Polyethylene Ossicular Replacement Class II
FDA product code LBM covers "Porous Polyethylene Ossicular Replacement", a Class II medical device regulated under 21 CFR 874.3450. Submissions are reviewed by the Ear, Nose, Throat panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LBM
- Device Class
- Class II
- Regulation Number
- 874.3450
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- Yes