The following data is part of a premarket notification filed by Kci Usa, Inc with the FDA for Activ.a.c. Negative Pressure Wound Therapy System.
| Device ID | K201571 |
| 510k Number | K201571 |
| Device Name: | ACTIV.A.C. Negative Pressure Wound Therapy System |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | KCI USA, Inc 6203 Farinon Drive San Antonio, TX 78249 |
| Contact | Jesus Valencia |
| Correspondent | Jesus Valencia KCI USA, Inc 6203 Farinon Drive San Antonio, TX 78249 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-11 |
| Decision Date | 2020-07-08 |