The following data is part of a premarket notification filed by Herniamesh with the FDA for Herniamesh Surgical Meshes.
| Device ID | K973955 |
| 510k Number | K973955 |
| Device Name: | HERNIAMESH SURGICAL MESHES |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | HERNIAMESH 1802 NO. 103 AVE. Omaha, NE 68114 |
| Contact | Lorena A Trabucco |
| Correspondent | Lorena A Trabucco HERNIAMESH 1802 NO. 103 AVE. Omaha, NE 68114 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-16 |
| Decision Date | 1998-05-11 |
| Summary: | summary |