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510(k) Data Aggregation

    K Number
    K012358
    Device Name
    CHIBA NEEDLE
    Manufacturer
    Date Cleared
    2001-10-15

    (82 days)

    Product Code
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    ISPG, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Chiba needles are used in a variety of procedures including biopsy, nerve block, pericardiocentesis, transhepatic cholorangiography as well as other applications where injection and/or aspiration of fluids are required.
    Device Description
    Chiba Needle
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    K Number
    K962886
    Device Name
    ANESTHESIA CONDUCTION NEEDLE
    Manufacturer
    Date Cleared
    1996-10-09

    (77 days)

    Product Code
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    ISPG, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K962042
    Device Name
    GLASS SYRINGE
    Manufacturer
    Date Cleared
    1996-10-08

    (133 days)

    Product Code
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    ISPG, INC.

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