The following data is part of a premarket notification filed by Kci Usa, Inc. with the FDA for Prevena Plus Incision Management System Kit With Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-pack, Prevena Plus Incision Management System Kit With Customizable Dressing, Prevena Plus Customizable Dressing 5-pack.
| Device ID | K153199 |
| 510k Number | K153199 |
| Device Name: | Prevena Plus Incision Management System Kit With Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit With Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | KCI USA, INC. 6203 FARINON DRIVE San Antonio, TX 78249 |
| Contact | Margaret Marsh |
| Correspondent | Margaret Marsh 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 | 2015-11-02 |
| Decision Date | 2016-02-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849554006621 | K153199 | 000 |
| 00849554005310 | K153199 | 000 |
| 00849554005303 | K153199 | 000 |