510(k) K161020 ยท PGZ Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
XSTAT-12, 3-Pack, XSTAT-12, 1-Pack
| Applicant | Revmedx, Inc., Wilsonville, OR, US |
| Decision | Substantially Equivalent, Jul 28, 2016 |
| Received | Apr 12, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161020
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.