510(k) K010675 ยท MDA Elastomer, Silicone, For Scar Management
ENSIL FABRIC
| Applicant | Gottfried Medical, Inc., Toledo OH, US |
| Decision | Substantially Equivalent, May 30, 2001 |
| Received | Mar 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010675
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.