K130040 is an FDA 510(k) clearance for the MEPITEL AG, a Dressing, Wound, Drug, submitted by Molnlycke Health Care (Norcross, US). The FDA issued a Cleared decision on February 12, 2014, 401 days after receiving the submission on January 7, 2013. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K130040 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 07, 2013 |
| Decision Date | February 12, 2014 |
| Days to Decision | 401 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |