510(k) K242634 ยท PHN Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
PuraStat
| Applicant | 3-D Matrix Europe SAS, Caluire Et Cuire, FR |
| Decision | Substantially Equivalent, Jan 15, 2025 |
| Received | Sep 3, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242634
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.