LBP — Replacement, Ossicular (Stapes) Using Absorbable Gelatin Material Class II
FDA product code LBP covers "Replacement, Ossicular (Stapes) Using Absorbable Gelatin Material", 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.
Classification Details
- Product Code
- LBP
- Device Class
- Class II
- Regulation Number
- 874.3450
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- Yes