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  • 1.  Class I, 510(k) exempt – product information

    This message was posted by a user wishing to remain anonymous
    Posted 26-Sep-2023 09:05
    This message was posted by a user wishing to remain anonymous

    Can anybody advise how can I search for device information (FDA class I exempt) that used to be FDA registered but currently has no active registration?
    I do not have its product code, and the FDA database of registration and listing presents only active registrations.

    Thanks



  • 2.  RE: Class I, 510(k) exempt – product information

    Posted 27-Sep-2023 08:10
    Anon,
    We have previous years in our SOFIE database.  Happy to look it up for you.  
    Melissa





  • 3.  RE: Class I, 510(k) exempt – product information

    Posted 28-Sep-2023 11:19

    Anon,

    You would need to find a resource which does have archived data such as a private server - but the FDA registration database only shows current registrations.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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