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

    BONE MARROW BIOPSY DEVICE

    K Number: K772293 · Decision Jan 3, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    47
    Applicant Total
    2
    Review Days
    22

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    Basic Information

    Device Name
    BONE MARROW BIOPSY DEVICE
    K Number
    K772293
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Radiation Development Co., Inc.
    Date Received
    December 12, 1977
    Decision Date
    January 3, 1978
    Product Code
    GDM
    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
    GDM Needle, Aspiration And Injection, Reusable

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    Other Clearances by Radiation Development Co., Inc.

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