Dear 510(k) experts, we have a device of which we have a 510(k). We make some changes to the device, and according to the flowchart about deciding when to submit a new 510(k), we conclude the applied changes don't require a new 510(k). Documenting the changes would be sufficient. BUT, the updated device is going to be marketed under a different name than the one mentioned on the original 510(k). Does that change the conclusion of whether or not to do a new filing?