K100029 is an FDA 510(k) clearance for the MEPILEX BORDER AG DRESSING, a Dressing, Wound, Drug, submitted by Molnlycke Health Care (Norcross, US). The FDA issued a Cleared decision on September 15, 2010, 252 days after receiving the submission on January 6, 2010. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K100029 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 06, 2010 |
| Decision Date | September 15, 2010 |
| Days to Decision | 252 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |