The following data is part of a premarket notification filed by Kci Usa, Inc. (kinetic Concepts, Inc.) with the FDA for Prevena Duo, Prevena Plus Duo Incision Management Systems With Peel & Place Dressings.
| Device ID | K161897 |
| 510k Number | K161897 |
| Device Name: | PREVENA DUO, PREVENA PLUS DUO Incision Management Systems With PEEL & PLACE Dressings |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | KCI USA, INC. (KINETIC CONCEPTS, INC.) 6203 FARINON DRIVE San Antonio, TX 78249 |
| Contact | Margaret Marsh |
| Correspondent | Margaret Marsh KCI USA, INC. (KINETIC CONCEPTS, 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 | 2016-07-11 |
| Decision Date | 2016-10-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849554006607 | K161897 | 000 |