510(k) K213228 ยท HBF Drills, Burrs, Trephines & Accessories (Compound, Powered)
NeuroLine Disposable Cranial Perforator with Hudson end
| Applicant | Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft., Debrecen, HU |
| Decision | Substantially Equivalent, Jun 20, 2022 |
| Received | Sep 29, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213228
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.