The following data is part of a premarket notification filed by Kerecis Limited with the FDA for Marigen Wound Dressing.
| Device ID | K132343 |
| 510k Number | K132343 |
| Device Name: | MARIGEN WOUND DRESSING |
| Classification | Dressing, Wound, Collagen |
| Applicant | KERECIS LIMITED EYRARGATA 2 Isafijordur, IS 400 |
| Contact | Gudmundur F Sigurjonsson |
| Correspondent | Gudmundur F Sigurjonsson KERECIS LIMITED EYRARGATA 2 Isafijordur, 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 | 2013-07-30 |
| Decision Date | 2013-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05694310960311 | K132343 | 000 |
| 05694310690096 | K132343 | 000 |
| 05694310961660 | K132343 | 000 |
| 05694310961622 | K132343 | 000 |
| 05694310961578 | K132343 | 000 |
| 05694310962445 | K132343 | 000 |
| 05694310962414 | K132343 | 000 |
| 05694310962391 | K132343 | 000 |
| 05694310964470 | K132343 | 000 |
| 05694310964517 | K132343 | 000 |
| 05694310690157 | K132343 | 000 |
| 05694310690133 | K132343 | 000 |
| 05694310960908 | K132343 | 000 |
| 05694310960236 | K132343 | 000 |
| 05694310960229 | K132343 | 000 |
| 05694310960205 | K132343 | 000 |
| 05694310960182 | K132343 | 000 |
| 05694310960151 | K132343 | 000 |
| 05694310960069 | K132343 | 000 |
| 05694310962247 | K132343 | 000 |
| 05694310962223 | K132343 | 000 |
| 05694310961608 | K132343 | 000 |
| 05694310964494 | K132343 | 000 |