The following data is part of a premarket notification filed by Kci Usa, Inc with the FDA for V.a.c. Dermatac Drape.
| Device ID | K200390 |
| 510k Number | K200390 |
| Device Name: | V.A.C. DERMATAC Drape |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | KCI USA, Inc 6203 Farinon Drive San Antonio, TX 78249 |
| Contact | Margaret Marsh |
| Correspondent | Margaret Marsh KCI USA, 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 | 2020-02-18 |
| Decision Date | 2020-05-18 |