510(k) K210676 ยท PGZ Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
XSTAT 30 Pouch
| Applicant | Revmedx, Inc., Wilsonville, OR, US |
| Decision | Substantially Equivalent, Aug 27, 2021 |
| Received | Mar 5, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210676
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.