510(k) K222972 · OVB Hydrogel Spacer
BioProtect Balloon Implant System
| Applicant | Bioprotect, Ltd., Tzur Yigal, IL |
| Decision | Substantially Equivalent, Aug 25, 2023 |
| Received | Sep 27, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222972
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.