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 | K181505 |
| 510k Number | K181505 |
| 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 | Melanie Avila |
| Correspondent | Melanie Avila 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 | 2018-06-07 |
| Decision Date | 2019-03-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20849554007202 | K181505 | 000 |
| 20849554007196 | K181505 | 000 |
| 20849554007189 | K181505 | 000 |
| 00849554005198 | K181505 | 000 |