510(k) K945892 ยท MDA Elastomer, Silicone, For Scar Management
SILON(R) SILICONE THERMOPLASTIC SHEETING
| Applicant | Bio Med Sciences, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, Mar 3, 1995 |
| Received | Dec 2, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945892
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.