510(k) K971916 ยท MDA Elastomer, Silicone, For Scar Management
MEDICAL Z, S.A. MEDIGEL Z SCAR MANAGEMENT GEL
| Applicant | Medical Z, S.A., Washington DC, US |
| Decision | Substantially Equivalent, Jul 29, 1997 |
| Received | May 23, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971916
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.