510(k) DEN180013 ยท QFC Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
PREVENA 125 and PREVENA PLUS 125 Therapy Units
| Applicant | Kci USA, Inc., San Antonio TX, US |
| Decision | Unknown, Apr 19, 2019 |
| Received | Mar 15, 2018 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN180013
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.