510(k) K964467 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
SHELHIGH PERICARDIAL PATCH
| Applicant | Shelhigh, Inc., Millburn NJ, US |
| Decision | Substantially Equivalent, Sep 23, 1997 |
| Received | Nov 7, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964467
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.