The following data is part of a premarket notification filed by Kci Usa, Inc. with the FDA for Prevena Plus Incision Management System (no Ag); Prevena Plus Duo Incision Management System (no Ag).
| Device ID | K190697 |
| 510k Number | K190697 |
| Device Name: | PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag) |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | KCI USA, Inc. 6203 Farinon Drive San Antonio, TX 78249 |
| Contact | Patricia Lopez |
| Correspondent | Patricia Lopez 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 | 2019-03-18 |
| Decision Date | 2019-11-22 |