510(k) K960254 ยท MDA Elastomer, Silicone, For Scar Management
SILGEL TOPICAL GEL SHEET
| Applicant | Rofil Medical USA, Inc., Laguna Hills CA, US |
| Decision | Substantially Equivalent, Apr 2, 1996 |
| Received | Jan 17, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960254
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.