The following data is part of a premarket notification filed by Novus Scientific Ab with the FDA for Tigr Matrix Surgical Mesh.
| Device ID | K163005 |
| 510k Number | K163005 |
| Device Name: | TIGR Matrix Surgical Mesh |
| Classification | Mesh, Surgical, Absorbable, Abdominal Hernia |
| Applicant | NOVUS SCIENTIFIC AB VIRDINGS ALLE Uppsala, SE 754 50 |
| Contact | Mats Norberg |
| Correspondent | Mats Norberg NOVUS SCIENTIFIC AB VIRDINGS ALLE Uppsala, SE 754 50 |
| Product Code | OWT |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-28 |
| Decision Date | 2017-07-27 |
| Summary: | summary |