510(k) K191475 ยท KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate
| Applicant | Nobel Biocare AB, Goteborg, SE |
| Decision | Substantially Equivalent, Aug 29, 2019 |
| Received | Jun 4, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191475
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.