We have received the 510(k) clearance letter. We also have prepared the submission of the new version of the cleared device, a new 510(k) which uses our cleared device as substantially equivalent. The new device includes wireless communication and some other changes but similar intended use.
This is the device we want to bring to the US market. Our idea is to submit the new 510(k) saving the costs of the registration and listing. Do you think this is possible? I haven't found anything that makes me think that we can't do it.
This is the device we want to bring to the US market. Our idea is to submit the new 510(k) saving the costs of the registration and listing. Do you think this is possible? I haven't found anything that makes me think that we can't do it.