The following data is part of a premarket notification filed by Kerecis Limited with the FDA for Kerecis Securemesh.
| Device ID | K153364 |
| 510k Number | K153364 |
| Device Name: | Kerecis SecureMesh |
| Classification | Mesh, Surgical, Collagen, Staple Line Reinforcement |
| Applicant | Kerecis Limited Eyrargata 2 Isafjordur, IS 400 |
| Contact | Gudmundur Fertram Sigurjonsson |
| Correspondent | Gudmundur Fertram Sigurjonsson Kerecis Limited Eyrargata 2 Isafjordur, IS 400 |
| Product Code | OXE |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-20 |
| Decision Date | 2016-08-19 |
| Summary: | summary |