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510(k) Data Aggregation

    K Number
    K021525
    Device Name
    TOPCUT
    Manufacturer
    H.S. HOSPITAL SERVICE S.R.L.
    Date Cleared
    2002-07-12

    (63 days)

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

    H.S. HOSPITAL SERVICE S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is a disposable biopsy needle and can be used in , CT, Mammographic Radiographic and Echographic procedures to obtain biopsies of various tissues including those from Prostate, Kidney, Breast and Liver using an automatic device.
    Device Description
    This device is a disposable biopsy needle
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    K Number
    K020987
    Device Name
    BMN I TYPE MARROW ASPIRATION NEEDLE
    Manufacturer
    H.S. HOSPITAL SERVICE S.R.L.
    Date Cleared
    2002-06-25

    (90 days)

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

    H.S. HOSPITAL SERVICE S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This biopsy instrument is used for drawing of osteomedullary substance and or for Explantation of bone marrow
    Device Description
    Not Found
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    K Number
    K013692
    Device Name
    TRAPSYSTEM SET
    Manufacturer
    H.S. HOSPITAL SERVICE S.R.L.
    Date Cleared
    2002-02-05

    (90 days)

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

    H.S. HOSPITAL SERVICE S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This biopsy instrument is used for drawing of osteomedullary substance and or for explantation of bone marrow.
    Device Description
    A disposable single use Biopsy Needle. The product consist of a 304 stainless steel cannula and 302 stainless steel stylet. The cannula is inserted molded into an ABS hub that provide a grip for manipulation of the Needle. Inside of the cannula is a stylet made by 302 stainless steel, inserted molded into an ABS hub. An additional patented stylet is provided to be used for trapping the sample in the cannula. An extracting 302 stainless steel wire with safety grip. The protective cover of cannula is made of polypropilene.
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    K Number
    K002944
    Device Name
    PRECISA BIOPSY NEEDLE
    Manufacturer
    H.S. HOSPITAL SERVICE S.R.L.
    Date Cleared
    2000-12-19

    (89 days)

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

    H.S. HOSPITAL SERVICE S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002946
    Device Name
    SILENT BIOPSY NEEDLE
    Manufacturer
    H.S. HOSPITAL SERVICE S.R.L.
    Date Cleared
    2000-12-19

    (89 days)

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

    H.S. HOSPITAL SERVICE S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K002947
    Device Name
    BIOMOL ASPIRATION BIOPSY NEEDLE
    Manufacturer
    H.S. HOSPITAL SERVICE S.R.L.
    Date Cleared
    2000-12-19

    (89 days)

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

    H.S. HOSPITAL SERVICE S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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