510(k) K122105 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
SMI CARDIOVASCULAR PATCH
| Applicant | Solinas Medical, Inc., Sunny Vale CA, US |
| Decision | Substantially Equivalent, Dec 7, 2012 |
| Received | Jul 17, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122105
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.