510(k) K946362 ยท MDA Elastomer, Silicone, For Scar Management
SILON SILICONE FOAM SHEETING
| Applicant | Bio Med Sciences, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, Jul 13, 1995 |
| Received | Dec 8, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946362
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.