510(k) K971468 ยท MDA Elastomer, Silicone, For Scar Management
SCAR HEAL
| Applicant | Specialty Systems, Inc., Western FL, US |
| Decision | Substantially Equivalent, Jun 10, 1997 |
| Received | Apr 22, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971468
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.