The following data is part of a premarket notification filed by Kerecis Limited with the FDA for Kerecis Reconstruct.
| Device ID | K202430 |
| 510k Number | K202430 |
| Device Name: | Kerecis Reconstruct |
| Classification | Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery |
| Applicant | Kerecis Limited Eyrargata 2 – PO Box 151 Isafjordur, IS 400 |
| Contact | Gudmundur Fertram Sigurjonsson |
| Correspondent | Gudmundur Fertram Sigurjonsson Kerecis Limited Eyrargata 2 – PO Box 151 Isafjordur, IS 400 |
| Product Code | OXH |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-25 |
| Decision Date | 2021-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05694310961981 | K202430 | 000 |
| 05694310963824 | K202430 | 000 |
| 05694310961721 | K202430 | 000 |
| 05694310961745 | K202430 | 000 |
| 05694310961769 | K202430 | 000 |
| 05694310961783 | K202430 | 000 |
| 05694310961806 | K202430 | 000 |
| 05694310961820 | K202430 | 000 |
| 05694310961844 | K202430 | 000 |
| 05694310961868 | K202430 | 000 |
| 05694310961882 | K202430 | 000 |
| 05694310961905 | K202430 | 000 |
| 05694310961929 | K202430 | 000 |
| 05694310961943 | K202430 | 000 |
| 05694310961967 | K202430 | 000 |
| 05694310963800 | K202430 | 000 |