| Device Type ID | 5934 |
| Device Name | Dressing, Wound And Burn, Occlusive |
| 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) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | MGP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5934 |
| Device | Dressing, Wound And Burn, Occlusive |
| Product Code | MGP |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 2 |
Appropriate Term/Code Not Available | 2 |
Delivered As Unsterile Product | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Human-Device Interface Problem | 1 |
Insufficient Information | 1 |
| Total Device Problems | 8 |