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510(k) Data Aggregation

    K Number
    K001026
    Device Name
    3D-MSPECT
    Date Cleared
    2000-06-20

    (82 days)

    Product Code
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE REAGENTS OF THE UNIVERSITY OF MICHIGAN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K964968
    Device Name
    MR EXTENSION SET (001)
    Date Cleared
    1997-02-27

    (77 days)

    Product Code
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIVERSITY OF MICHIGAN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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