The following data is part of a premarket notification filed by Kci Usa, Inc. (kinetic Concepts, Inc.) with the FDA for V.a.c.ulta Negative Pressure Wound Therapy System.
| Device ID | K162790 |
| 510k Number | K162790 |
| Device Name: | V.A.C.ULTA Negative Pressure Wound Therapy System |
| 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 | 2016-10-04 |
| Decision Date | 2017-01-26 |
| Summary: | summary |