Selecting a predicate device for FDA 510(k) approval

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MIREGMGR

#11
How can I see my predicates' 510K full submission?
You can search for available information here. However, the only information that is required to be public is either a Statement or a Summary, as defined in the rules. An FOIA request for more than that will result in the original information submitter being given an opportunity to declare whatever information they select as proprietary and confidential, and such information will be redacted from whatever is provided to you.
 
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