510(k) K002109 ยท MDA Elastomer, Silicone, For Scar Management
OLEEVA FOAM
| Applicant | Bio Med Sciences, Inc., Allentown PA, US |
| Decision | Substantially Equivalent, Aug 31, 2000 |
| Received | Jul 12, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002109
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.