Kci USA, Inc. · Class II · Cleared Nov 6, 2015
| K-number | K150006 |
| Device name | Prevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System with Customizable Dressing |
| Applicant | Kci USA, Inc. |
| Product code | OMP |
| Device class | Class II |
| Decision date | Nov 6, 2015 |
| Decision | Substantially Equivalent |
| Regulation | 878.4780 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov