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Hi there,
We have a cleared medical device (that is we are the 510k owner), and we?d like to change the Trade name, model number and distributor information on the labeling (as the device will be distributed by another client under their system). What should we do? I mean, do we need to apply for it for what we going to do? What kind of application is that?
Do anyone has an idea about that?
We have a cleared medical device (that is we are the 510k owner), and we?d like to change the Trade name, model number and distributor information on the labeling (as the device will be distributed by another client under their system). What should we do? I mean, do we need to apply for it for what we going to do? What kind of application is that?
Do anyone has an idea about that?
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