510(k) K981353 ยท MDA Elastomer, Silicone, For Scar Management
AVOGEL
| Applicant | Avocet Polymer Technologies, Inc., Huntsville AL, US |
| Decision | Substantially Equivalent, Jun 1, 1999 |
| Received | Apr 14, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981353
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.