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  • 1.  Found 510k error

    This message was posted by a user wishing to remain anonymous
    Posted 13-Mar-2023 13:29
    This message was posted by a user wishing to remain anonymous

    Hello,

    I recently started at a medical device company and after reviewing an approved 510k submission I found an addition error in one of the tables.  This table gives the measurements for one of the devices components.  The individual measurements are correct but when added together the final measurement is incorrect. How can I fix this error?

    Thanks



  • 2.  RE: Found 510k error

    Posted 13-Mar-2023 14:58

    Hi ,

     It will depend on the type of device and how significant is the size of the component for the device safety and efficacy.

    if it is significant 510k has to be updated , if not design file has to updated and documented 



    ------------------------------
    Raje Devanathan
    Amerisource Bergen
    TPIreg, Innomar Strategies
    Senior Manager - Regulatory Affairs, Medical Devices
    rdevanathan@tpireg.com
    3470 Superior Court
    Oakville ON L6L0C4
    Canada
    ------------------------------

    Original Message


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