BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY

    K Number: K955683 · Decision Feb 1, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    6
    Applicant Total
    18
    Review Days
    49

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    Basic Information

    Device Name
    RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY
    K Number
    K955683
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Contour Fabricators of Florida, Inc.
    Date Received
    December 14, 1995
    Decision Date
    February 1, 1996
    Product Code
    MJG
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MJG Device, Percutaneous, Biopsy

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