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510(k) Data Aggregation

    K Number
    K962905
    Device Name
    TX BIOPSY NEEDLE
    Manufacturer
    GALLINI S.R.L.
    Date Cleared
    1996-10-11

    (78 days)

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

    GALLINI S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is an automated, disposable and adjustable biopsy instrument designed for ultimate accuracy in obtaining high quality histological core samples, with three different choice of penetration depth and obtaining histological samples from 0.8 to 1.9 mm length.
    Device Description
    This device is an automatic disposable biopsy Needle developed for taking a range of tissue specimens, including those from the prostate, kidney and liver.
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