The following data is part of a premarket notification filed by Kci Usa, Inc. with the FDA for Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System.
| Device ID | K180855 |
| 510k Number | K180855 |
| Device Name: | Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | KCI USA, Inc. 6203 Farinon Drive San Antonio, TX 78249 |
| Contact | Kimberly Mccoy |
| Correspondent | Kimberly Mccoy 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 | Yes |
| Date Received | 2018-04-02 |
| Decision Date | 2018-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849554007819 | K180855 | 000 |