| Term | 510(k) clearance |
| Variations | 510(k) certification, Premarket Notification, PMN |
| See also | FDA, Food and Drug Administration |
| Definition | A system for registering new medical devices with the FDA (Federal Drug Administration). New devices must be registered 90 days before going to market so they can be classified. |
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A sample term:
submersible endosteal implant