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510(k) Data Aggregation

    K Number
    K093901
    Device Name
    SURGICAL FACE MASK
    Date Cleared
    2010-09-10

    (262 days)

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

    EPARD PROTECTIVE PRODUCTS, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material.
    Device Description
    Surgical Face Mask ear loop yellow, Surgical Face Mask ear loop blue, Surgical Face Mask tie-on yellow, and Surgical Face Mask tie-on blue
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