510(k) K003948 ยท MDA Elastomer, Silicone, For Scar Management
EPI-DERM SILICONE GEL SHEETING
| Applicant | Biodermis Corp., Las Vegas NV, US |
| Decision | Substantially Equivalent, Jan 29, 2001 |
| Received | Dec 21, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003948
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.