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 |
05694310964371 | K213231 | 000 |