The following data is part of a premarket notification filed by Kci Usa, Inc. with the FDA for Prevena Incision Management System With Peel & Place Dressing, Prevena Incision Management System With Customizable Dressing.
| Device ID | K150006 |
| 510k Number | K150006 |
| Device Name: | Prevena Incision Management System With Peel & Place Dressing, Prevena Incision Management System With Customizable Dressing |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | KCI USA, INC. 6203 FARINON DRIVE San Antonio, TX 78249 |
| Contact | Melanie Avila |
| Correspondent | Melanie Avila KCI USA, INC. 6203 FARINON DRIVE San Antonio, TX 78249 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-02 |
| Decision Date | 2015-11-06 |
| Summary: | summary |