The following data is part of a premarket notification filed by Kerecis with the FDA for Kerecis Oral.
| Device ID | K213904 |
| 510k Number | K213904 |
| Device Name: | Kerecis Oral |
| Classification | Barrier, Animal Source, Intraoral |
| Applicant | Kerecis Eyrargata 2 Isafjordur, IS 400 |
| Contact | Gudmundur Fertram Sigurjonsson |
| Correspondent | Gudmundur Fertram Sigurjonsson Kerecis Eyrargata 2 Isafjordur, IS 400 |
| Product Code | NPL |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-14 |
| Decision Date | 2022-09-30 |