K100591 is an FDA 510(k) clearance for the SORBACT, a Dressing, Wound, Drug, submitted by Abigo Medical AB (Fridley, US). The FDA issued a Cleared decision on January 24, 2011, 328 days after receiving the submission on March 2, 2010. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K100591 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 02, 2010 |
| Decision Date | January 24, 2011 |
| Days to Decision | 328 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |