510(k) K250420 ยท GXQ Dura Substitute
Helios Dura Regeneration Matrix
| Applicant | Helios Biomedical, Inc., Weston MA, US |
| Decision | Substantially Equivalent, May 14, 2025 |
| Received | Feb 13, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250420
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.