510(k) K913140 ยท MDA Elastomer, Silicone, For Scar Management
SILICONE GEL SHEETING
| Applicant | Cui Corp., Santa Barbara CA, US |
| Decision | Substantially Equivalent, Sep 30, 1991 |
| Received | Jul 16, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913140
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.