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510(k) Data Aggregation

    K Number
    K000421
    Device Name
    BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE
    Date Cleared
    2000-08-14

    (188 days)

    Product Code
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    SSL AMERICAS, INC. (REGENT MEDICAL)

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