The following data is part of a premarket notification filed by Feg Textiltechnik Forschungs-und Entwicklungsgesel with the FDA for Dynamesh -cicat.
| Device ID | K131530 |
| 510k Number | K131530 |
| Device Name: | DYNAMESH -CICAT |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESEL HERLINGTON HOUSE, ORTON MALBORNE Peterborough, Cambs., GB Pe2 5xs |
| Contact | Neil R Armstrong |
| Correspondent | Neil R Armstrong FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESEL HERLINGTON HOUSE, ORTON MALBORNE Peterborough, Cambs., GB Pe2 5xs |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-28 |
| Decision Date | 2013-10-23 |
| Summary: | summary |