| Device Type ID | 5671 |
| Device Name | Pad, Eye |
| Regulation Description | Eye Pad. |
| 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) Exempt |
| CFR Regulation Number | 878.4440 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | HMP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5671 |
| Device | Pad, Eye |
| Product Code | HMP |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Eye Pad. |
| CFR Regulation Number | 878.4440 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Covidien LLC | II | Mar-27-2017 |