The following data is part of a premarket notification filed by Kerecis Limited with the FDA for Kerecis Silicone.
| Device ID | K213231 |
| 510k Number | K213231 |
| Device Name: | Kerecis Silicone |
| 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 | 2021-09-30 |
| Decision Date | 2022-06-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05694310963787 | K213231 | 000 |
| 05694310963763 | K213231 | 000 |
| 05694310964326 | K213231 | 000 |