510(k) K152533 ยท FRO Dressing, Wound, Drug
Xonrid Gel
| Applicant | Helsinn Healthcare SA, Lugano, CH |
| Decision | Substantially Equivalent, Oct 28, 2016 |
| Received | Sep 3, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152533
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.