K100927 is an FDA 510(k) clearance for the SURGIAID, a Wound Dressing With Animal-derived Material(s), submitted by Maxigen Biotech, Inc. (Flagstaff, US). The FDA issued a Cleared decision on February 2, 2011, 303 days after receiving the submission on April 5, 2010. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K100927 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 05, 2010 |
| Decision Date | February 02, 2011 |
| Days to Decision | 303 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 | — |