510(k) K981902 ยท MDA Elastomer, Silicone, For Scar Management
SPENCO SILICONE GEL SHEET
| Applicant | Spenco Medical Corp., Waco TX, US |
| Decision | Substantially Equivalent, Jun 25, 1998 |
| Received | Jun 1, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981902
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.