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Old 4th November 2009, 09:57 PM
aoldendo aoldendo is offline
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Question 510(k) Ownership Change - Is it painful or is it a pretty easy process
This is only tangentially related to 21 CFR Part 820, but I was wondering if anyone had first hand knowledge of changing ownership of a 510(k). Is it painful or is it a pretty easy process to carry out on the FDA's device and registration database??

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Old 4th November 2009, 10:20 PM
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Default Re: 510(k) Ownership Change
Is there any answer? I am also interested in this topic
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Old 5th November 2009, 02:50 AM
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Default Re: 510(k) Ownership Change
Go to the secure FDA DRML database, where you register establishments and list products. Your company's secure ID is required. Several options are available there for ownership changes, and it's possible to interact with a real person via phone or email, who can help with sorting out technical questions.
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