510(k) K250512 ยท NPL Barrier, Animal Source, Intraoral
Augmented Gingival Matrix
| Applicant | Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Dec 5, 2025 |
| Received | Feb 21, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250512
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.