Device Type ID | 5748 |
Device Name | Implant, Temporal |
Regulation Description | Chin 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 | 878.3550 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | MNF |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5748 |
Device | Implant, Temporal |
Product Code | MNF |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Chin Prosthesis. |
CFR Regulation Number | 878.3550 [🔎] |