510(k) K190342 ยท FRO Dressing, Wound, Drug
BIAFINE Topical Cream
| Applicant | Bausch Health Americas Incorporated, Rochester NY, US |
| Decision | Substantially Equivalent, Oct 18, 2019 |
| Received | Feb 14, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190342
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.