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510(k) Data Aggregation

    K Number
    K954911
    Device Name
    OMEGA ULTRASCAN
    Date Cleared
    1996-01-24

    (91 days)

    Product Code
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    GYNE-TECH INSTRUMENT CORP.

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