K143124 is an FDA 510(k) clearance for the KA01 Chitosan Wound Dressing. This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Foshan United Medical Technologies, Ltd. (Shishan, Nanhai, Foshan, CN). The FDA issued a Cleared decision on January 26, 2015, 87 days after receiving the submission on October 31, 2014.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K143124 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2014 |
| Decision Date | January 26, 2015 |
| Days to Decision | 87 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 | - |