| Device Type ID | 5565 |
| Device Name | Prosthesis, Ear, Internal |
| Regulation Description | Ear Prosthesis. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.3590 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FZD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5565 |
| Device | Prosthesis, Ear, Internal |
| Product Code | FZD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ear Prosthesis. |
| CFR Regulation Number | 878.3590 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
IMPLANTECH ASSOCIATES INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |