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510(k) Data Aggregation

    K Number
    K963568
    Device Name
    MASK SURGICAL
    Date Cleared
    1997-02-25

    (173 days)

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

    THE INNOVATIVE APPROACH, CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The INTENDED MEDICAL USE is to protect the healthcare personnel and patient from transfer of microorganisms, body fluids and particulate material.
    Device Description
    Not Found
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