510(k) K111733 ยท MDA Elastomer, Silicone, For Scar Management
CORELEADER SCAR-DIMMER
| Applicant | Coreleader Biotech Co., Ltd., New Taipei, Taiwan, TW |
| Decision | Substantially Equivalent, Sep 22, 2011 |
| Received | Jun 21, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111733
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.