The following data is part of a premarket notification filed by Genzyme Corporation with the FDA for Sepramesh, Model 5959-1214.
| Device ID | K063739 |
| 510k Number | K063739 |
| Device Name: | SEPRAMESH, MODEL 5959-1214 |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | GENZYME CORPORATION 500 KENDALL STREET Cambridge, MA 02142 |
| Contact | Matthew Hibbert |
| Correspondent | Matthew Hibbert GENZYME CORPORATION 500 KENDALL STREET Cambridge, MA 02142 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-18 |
| Decision Date | 2007-01-17 |
| Summary: | summary |