510(k) K994032 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
FLUORO-TEX CARDIOVASCULAR PATCH
| Applicant | Bridger Biomed, Inc., Bozeman MT, US |
| Decision | Substantially Equivalent, Jul 7, 2000 |
| Received | Nov 26, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994032
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.