510(k) K013732 ยท MDA Elastomer, Silicone, For Scar Management
GELZONE
| Applicant | Implantech Associates, Inc., Ventura CA, US |
| Decision | Substantially Equivalent, Feb 7, 2002 |
| Received | Nov 9, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013732
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.