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510(k) Data Aggregation

    K Number
    K000685
    Device Name
    CHARTER MEDICAL NEONATAL SYRINGE SET
    Manufacturer
    CHARTER MEDICAL, LTD.
    Date Cleared
    2000-08-15

    (168 days)

    Product Code
    BRZ
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHARTER MEDICAL, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K990310
    Device Name
    CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)
    Manufacturer
    CHARTER MEDICAL, LTD.
    Date Cleared
    1999-08-30

    (210 days)

    Product Code
    CAK
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHARTER MEDICAL, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Single use device for the removal of microaggregate and particulate debris from whole blood and red blood cells (RBCs) during infusion.
    Device Description
    40 micron filter offered both as a stand alone device and as an integral component of a Y-Blood Administration Set.
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