The following data is part of a premarket notification filed by Artimplant Ab with the FDA for Sportmesh Or Artelon Tissue Reinforcement.
| Device ID | K071887 |
| 510k Number | K071887 |
| Device Name: | SPORTMESH OR ARTELON TISSUE REINFORCEMENT |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | ARTIMPLANT AB 719 A STREET NE Washington, DC 20002 |
| Contact | Terry S Powell |
| Correspondent | Terry S Powell ARTIMPLANT AB 719 A STREET NE Washington, DC 20002 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-09 |
| Decision Date | 2007-09-18 |
| Summary: | summary |