510(k) K053481 ยท MDA Elastomer, Silicone, For Scar Management
KELO-COTE SPRAY
| Applicant | Advanced Bio-Technologies, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Apr 14, 2006 |
| Received | Dec 14, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053481
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.