510(k) K991604 ยท MDA Elastomer, Silicone, For Scar Management
EPI-FOAM SILICONE SHEETING
| Applicant | Biodermis Corp., Las Vegas NV, US |
| Decision | Substantially Equivalent, Jun 9, 1999 |
| Received | May 10, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991604
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.