510(k) K170334 ยท PGZ Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack
| Applicant | Revmedx, Inc., Wilsonville, OR, US |
| Decision | Substantially Equivalent, May 1, 2017 |
| Received | Feb 2, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170334
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.