K113104 is an FDA 510(k) clearance for the INTEGRA WOUND MATRIX (THIN). This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on February 9, 2012, 112 days after receiving the submission on October 20, 2011.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K113104 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 2011 |
| Decision Date | February 09, 2012 |
| Days to Decision | 112 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 | — |