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comment_16601

I have a question that maybe someone can point me in the right direction. If a company acquires a 510k cleared software devices and they want to change the name of the original software to reflect the new company's name is there a regulation that describes this process or any forms that need to be completed and submitted?

Thank You.

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comment_16611

I don't understand. Are you with an institution that purchased the software for your use, or are you with a software or instrumentation company that now owns the 510k-cleared software devices (which you plan to market to others?)

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comment_16628

We are a software company that has acquired a 510k-cleared software device that we do plan to market to others.

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