FDA 510k submission | |
FDA 510(k) submission is a regulatory process required for medical device manufacturers to demonstrate that their product is substantially equivalent to a legally marketed device. It ensures safety and effectiveness before commercialization in the U.S. This premarket notification is crucial for gaining FDA clearance for Class II medical devices. | |
| Related Link: Click here to visit item owner's website (0 hit) | |
| Target State: All States Target City : All Cities Last Update : Jul 14, 2025 4:59 AM Number of Views: 14 | Item Owner : FDA 510k submission Contact Email: Contact Phone: (None) |
| Friendly reminder: Click here to read some tips. | |