510(k) K953289 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
TETRAFLUOROETHYLENE (TFE) POLYMER PLEDGET
| Applicant | Davis & Geck, Inc., Danbury CT, US |
| Decision | Substantially Equivalent, Aug 21, 1995 |
| Received | Jul 14, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953289
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.