K190528 is an FDA 510(k) clearance for the MariGen Wound Extra. This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Kerecis Limited (Isafjordur, IS). The FDA issued a Cleared decision on July 10, 2019, 128 days after receiving the submission on March 4, 2019.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K190528 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2019 |
| Decision Date | July 10, 2019 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KGN - Wound Dressing With Animal-derived Material(s) |
| Device Class | - |