Sofradim Production · Class II · Cleared Mar 9, 2018
| K-number | K173796 |
| Device name | Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) |
| Applicant | Sofradim Production |
| Product code | FTL |
| Device class | Class II |
| Decision date | Mar 9, 2018 |
| Decision | Substantially Equivalent |
| Regulation | 878.3300 |
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