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510(k) Data Aggregation

    K Number
    K972066
    Device Name
    BELZER-MPS
    Manufacturer
    TRANS-MED CORP.
    Date Cleared
    1997-11-26

    (176 days)

    Product Code
    KDN
    Regulation Number
    876.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRANS-MED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Belzer~MPS™ is the UW-gluconate perfusion solution indicated for the flushing and continuous hypothermic machine perfusion of donor kidneys.
    Device Description
    Belzer-MPSTM is the UW-gluconate perfusion solution
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