The following data is part of a premarket notification filed by Novus Scientific Ab with the FDA for Tigr Matrix Surgical Mesh, Tigr Surgical Mesh.
| Device ID | K191749 |
| 510k Number | K191749 |
| Device Name: | TIGR Matrix Surgical Mesh, TIGR Surgical Mesh |
| Classification | Mesh, Surgical, Absorbable, Abdominal Hernia |
| Applicant | Novus Scientific AB Virdings Alle 2 Uppsala, SE Se-754 50 |
| Contact | Thomas Engstrom |
| Correspondent | Loredana M Guseila Cygnus Regulatory, LLC 5555 E Palo Verde Drive Paradise Valley, AZ 85253 |
| Product Code | OWT |
| Subsequent Product Code | FTL |
| Subsequent Product Code | OOD |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-01 |
| Decision Date | 2020-03-26 |
| Summary: | summary |