510(k) K083718 ยท MDA Elastomer, Silicone, For Scar Management
BEAU RX SCAR CARE GEL
| Applicant | Beau RX Solutions, LLC, Melbourne Beach FL, US |
| Decision | Substantially Equivalent, Jan 26, 2009 |
| Received | Dec 15, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083718
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.