| Device |
mesh, surgical, collagen, large abdominal wall defects |
| Regulation Description |
Surgical mesh. |
| Definition |
For reinforcement of soft tissue where weakness exists in abdominal wall defects. |
| Physical State |
A collagen mesh; either square, rectangular, round or of various other shapes |
| Technical Method |
A collagen mesh that reinforces soft tissue |
| Target Area |
Abdominal wall |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | OXK |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.3300
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
