510(k) K011487 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS
| Applicant | Somanetics Corp., Troy MI, US |
| Decision | Substantially Equivalent, Nov 21, 2001 |
| Received | May 15, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011487
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.