510(k) K031785 ยท OMH Pericardial Patch To Facilitate Revision Surgeries
MACROPORE CARDIO-WRAP (TS)
| Applicant | Macropore Biosurgery, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Sep 4, 2003 |
| Received | Jun 10, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031785
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.