510(k) K840113 ยท MDA Elastomer, Silicone, For Scar Management
SILICONE SPLINTING MATERIAL
| Applicant | General Dental Products, Inc., Elk Grove Village IL, US |
| Decision | Substantially Equivalent, Apr 17, 1985 |
| Received | Jan 11, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K840113
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.