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

    WHEEL CHAIR ACCESSORY

    K Number: K963489 · Decision Nov 12, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    133
    Applicant Total
    15
    Review Days
    70

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    Basic Information

    Device Name
    WHEEL CHAIR ACCESSORY
    K Number
    K963489
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6760
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith and Nephew Donjoy, Inc.
    Date Received
    September 3, 1996
    Decision Date
    November 12, 1996
    Product Code
    FMQ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FMQ Restraint, Protective

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