510(k) K002488 ยท MDA Elastomer, Silicone, For Scar Management
KELO-COTE TOPICAL GEL
| Applicant | Advanced Bio-Technologies, Inc., Cranage, Cheshire, GB |
| Decision | Substantially Equivalent, Jan 5, 2001 |
| Received | Aug 14, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002488
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.