BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    BIOPSY TRAY I & II

    K Number: K854095 · Decision Nov 25, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    109
    Applicant Total
    6
    Review Days
    49

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    Basic Information

    Device Name
    BIOPSY TRAY I & II
    K Number
    K854095
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    North Coast Medi-Tek
    Date Received
    October 7, 1985
    Decision Date
    November 25, 1985
    Product Code
    LRO
    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
    LRO General Surgery Tray

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