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  • 1.  510(k) statement and request for redacted information

    This message was posted by a user wishing to remain anonymous
    Posted 28-Mar-2019 09:58
    This message was posted by a user wishing to remain anonymous

    ​Hi,

     Is there a procedure defined (form) to request for the redacted predicate 510(k) information once they have not made a summary available?

    Dos the FDA need to copied on to the communication

    How do we ascertain that only the information that are allowed to be redacted is actually redacted ?

    Thanks,


  • 2.  RE: 510(k) statement and request for redacted information

    Posted 03-Apr-2019 12:35
    You can request redacted copies of 510(k)s via the Freedom of Information Act.

    FOIA Request

    My recollection is that FDA reviews the firm's redactions and will make them public if they're not permitted to keep that information confidential.

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    Mike Loiterman RAC
    Naperville IL
    United States
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    Original Message


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