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

    BONE MARROW BIOPSY TRAY

    K Number: K941846 · Decision May 18, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    109
    Applicant Total
    2
    Review Days
    34

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    Basic Information

    Device Name
    BONE MARROW BIOPSY TRAY
    K Number
    K941846
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kormed, Inc.
    Date Received
    April 14, 1994
    Decision Date
    May 18, 1994
    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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    Other Clearances by Kormed, Inc.

    K Number Device Name
    K944044 CHIBA STYLE BIOPSY NEEDLE