The following data is part of a premarket notification filed by Feg Textiltechnik Forschungs-und Entwicklungsgesellschaft with the FDA for Dynamesh-ventral.
| Device ID | K161550 |
| 510k Number | K161550 |
| Device Name: | DynaMesh-VENTRAL |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESELLSCHAFT PRAGER RING 70 Aachen, DE D-52070 |
| Contact | Stefan Schneemelcher |
| Correspondent | Neil R. Armstrong MEDDIQUEST LIMITED HERLINGTON HOUSE ORTON MALBORNE Peterborough, 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 | 2016-06-03 |
| Decision Date | 2016-12-22 |
| Summary: | summary |