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

    INTRA-ARTICULATED ARTHRO POWER SYSTEM

    K Number: K871250 · Decision Apr 27, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    366
    Applicant Total
    142
    Review Days
    28

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    Basic Information

    Device Name
    INTRA-ARTICULATED ARTHRO POWER SYSTEM
    K Number
    K871250
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.2220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Richard Wolf Medical Instruments Corp.
    Date Received
    March 30, 1987
    Decision Date
    April 27, 1987
    Product Code
    KIT
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KIT Media And Components, Synthetic Cell And Tissue Culture

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