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

    STRYKER COMMAND2 OFFICE CONSOLE

    K Number: K953071 · Decision Aug 8, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    9
    Applicant Total
    74
    Review Days
    39

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    Basic Information

    Device Name
    STRYKER COMMAND2 OFFICE CONSOLE
    K Number
    K953071
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4960
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Instruments
    Date Received
    June 30, 1995
    Decision Date
    August 8, 1995
    Product Code
    JEA
    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
    JEA Table, Surgical With Orthopedic Accessories, Ac-Powered

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