510(k) K974143 ยท MDA Elastomer, Silicone, For Scar Management
KMC NEWSKIN
| Applicant | Kmc Intl. Co., Pasadena CA, US |
| Decision | Substantially Equivalent, Mar 27, 1998 |
| Received | Nov 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974143
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.