The following data is part of a premarket notification filed by Kci, A Part Of 3m Health Care Business Group with the FDA for V.a.c.ulta Negative Pressure Wound Therapy System.
| Device ID | K203316 |
| 510k Number | K203316 |
| Device Name: | V.A.C.ULTA Negative Pressure Wound Therapy System |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | KCI, A Part Of 3M Health Care Business Group 6203 Farinon Drive San Antonio, TX 78249 |
| Contact | Margaret Marsh |
| Correspondent | Margaret Marsh KCI, A Part Of 3M Health Care Business Group 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 | 2020-11-10 |
| Decision Date | 2021-10-27 |