510(k) K191536 ยท FRO Dressing, Wound, Drug
Biatain Silicone Ag
| Applicant | Coloplast A/S, Humlebaek, DK |
| Decision | Substantially Equivalent, Feb 21, 2020 |
| Received | Jun 10, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191536
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.