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510(k) Data Aggregation

    K Number
    K970871
    Device Name
    TR NEEDLE
    Manufacturer
    GALLINI INTL., INC.
    Date Cleared
    1997-05-21

    (72 days)

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

    GALLINI INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The needle is designed to be used for soft tissue histological biopsy.
    Device Description
    Not Found
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    K Number
    K970872
    Device Name
    PAN (CHIBA ASPIRATING NEEDLE)
    Manufacturer
    GALLINI INTL., INC.
    Date Cleared
    1997-05-21

    (72 days)

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

    GALLINI INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is to be used for taking cyto-histological biopsies of soft tissue.
    Device Description
    Pan® Aspirating Needle (Chiba)
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    K Number
    K964777
    Device Name
    TZ
    Manufacturer
    GALLINI INTL., INC.
    Date Cleared
    1997-01-03

    (37 days)

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

    GALLINI INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to be used to take high quality histological core samples from soft tissue, including (but not limited to) liver, kidney, prostate.
    Device Description
    The device is a spring loaded, disposable biopsy needle.
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    K Number
    K962569
    Device Name
    BIOMID BONE MARROW BIOPSY NEEDLE
    Manufacturer
    GALLINI INTL., INC.
    Date Cleared
    1996-11-27

    (149 days)

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

    GALLINI INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to be used for drawing osteomedullary substances and/or the explantation of bone marrow.
    Device Description
    A manually operated biopsy needle used for aspiration or explantation of bony substance.
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    K Number
    K962570
    Device Name
    ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE
    Manufacturer
    GALLINI INTL., INC.
    Date Cleared
    1996-11-27

    (149 days)

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

    GALLINI INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to be used for drawing osteomedullary substances from the sternum or from the iliac crest.
    Device Description
    A manually operated biopsy needle used for aspiration or explantation of bony substance.
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    K Number
    K962568
    Device Name
    ACRI ILIAC CREST ASPIRATION BIOPSY NEEDLES
    Manufacturer
    GALLINI INTL., INC.
    Date Cleared
    1996-11-25

    (147 days)

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

    GALLINI INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to be used for drawing osteomedullary substances from the iliac crest.
    Device Description
    A manually operated biopsy needle used for aspiration or explantation of bony substance.
    Ask a Question
    K Number
    K961407
    Device Name
    SPEED-CUT
    Manufacturer
    GALLINI INTL., INC.
    Date Cleared
    1996-11-21

    (224 days)

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

    GALLINI INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An automatic biopsy system designed to take core samples from a variety of soft tissues, including (but not limited to) liver, prostate, kidney.
    Device Description
    The Speed-Cut® is an automatic spring loaded, depth programmable, disposable biopsy instrument.
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