510(k) K112683 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
SMI CARDIOVASCULAR PACH
| Applicant | Solimas Medical, Inc., Sunny Vale CA, US |
| Decision | Substantially Equivalent, Dec 14, 2011 |
| Received | Sep 15, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112683
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.