The following data is part of a premarket notification filed by Kerecis Limited with the FDA for Marigen Wound Extra.
| Device ID | K190528 |
| 510k Number | K190528 |
| Device Name: | MariGen Wound Extra |
| Classification | Dressing, Wound, Collagen |
| 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 | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-04 |
| Decision Date | 2019-07-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05694310961554 | K190528 | 000 |
| 05694310963862 | K190528 | 000 |
| 05694310963886 | K190528 | 000 |
| 05694310963909 | K190528 | 000 |
| 05694310963923 | K190528 | 000 |
| 05694310963947 | K190528 | 000 |
| 05694310961547 | K190528 | 000 |
| 05694310960717 | K190528 | 000 |
| 05694310960724 | K190528 | 000 |
| 05694310960762 | K190528 | 000 |
| 05694310960786 | K190528 | 000 |
| 05694310961042 | K190528 | 000 |
| 05694310961066 | K190528 | 000 |
| 05694310961141 | K190528 | 000 |
| 05694310961165 | K190528 | 000 |
| 05694310963848 | K190528 | 000 |