The following data is part of a premarket notification filed by Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft with the FDA for Dynamesh-posterior.
| Device ID | K182087 |
| 510k Number | K182087 |
| Device Name: | DynaMesh-POSTERIOR |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | FEG Textiltechnik Forschungs- Und Entwicklungsgesellschaft mbH Prager Ring 70 Aachen, DE D-52070 |
| Contact | Stefan Schneemelcher |
| Correspondent | Neil R. Armstrong MeddiQuest Regulatory Affairs Ltd Unit 73B Hebron Industrial Estate Kilkenny, IE R95 Crk2 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-02 |
| Decision Date | 2018-10-31 |
| Summary: | summary |