510(k) K200566 ยท PSQ Intracardiac Patch Or Pledget, Biologically Derived
ADAPT Tissue
| Applicant | Admedus Regen Pty, Ltd., Malaga, AU |
| Decision | Substantially Equivalent, Apr 3, 2020 |
| Received | Mar 4, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200566
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.