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510(k) Data Aggregation

    K Number
    K031128
    Device Name
    B-SMART, MODEL B-01
    Manufacturer
    MACOSTA MEDICAL USA, LLC
    Date Cleared
    2004-01-15

    (281 days)

    Product Code
    CAZ
    Regulation Number
    868.5140
    Why did this record match?
    Applicant Name (Manufacturer) :

    MACOSTA MEDICAL USA, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Macosta Medical B-Smart Nerve Block Injection Pressure Manometer is a device for measuring injection pressure during administration of peripheral nerve blocks.
    Device Description
    Not Found
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