510(k) K012419 ยท MDA Elastomer, Silicone, For Scar Management
CONFORM SHEETING, MODEL IGEL
| Applicant | Implantech Associates, Inc., Ventura CA, US |
| Decision | Substantially Equivalent, Oct 24, 2001 |
| Received | Jul 30, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012419
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.