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510(k) Data Aggregation

    K Number
    K970440
    Device Name
    EKONIC DENTAL/MEDICAL MASK (MD 610)
    Date Cleared
    1997-03-27

    (50 days)

    Product Code
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    EKONIC COMPANY, LTD.

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