510(k) K162579 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
VascuCel
| Applicant | Admedus Regen Pty, Ltd., Malaga, AU |
| Decision | Substantially Equivalent, Oct 14, 2016 |
| Received | Sep 15, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K162579
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.