The following data is part of a premarket notification filed by Kci Usa, Inc. with the FDA for Activac Therapy Unit And Infovac Therapy Unit, Vac Ats Therapy Unit And Vac Freedom Therapy Unit, Vac Via Therapy Unit.
| Device ID | K120033 |
| 510k Number | K120033 |
| Device Name: | ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | KCI USA, INC. 6203 FARINON DR. San Antonio, TX 78249 |
| Contact | Shannon Scott |
| Correspondent | Shannon Scott KCI USA, INC. 6203 FARINON DR. 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 | 2012-01-04 |
| Decision Date | 2012-05-31 |
| Summary: | summary |