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

    CHOP SPINE FRAME

    K Number: K883295 · Decision Aug 23, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    3
    Applicant Total
    6
    Review Days
    19

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    Basic Information

    Device Name
    CHOP SPINE FRAME
    K Number
    K883295
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4950
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Avec Scientific Design Corp.
    Date Received
    August 4, 1988
    Decision Date
    August 23, 1988
    Product Code
    LWG
    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
    LWG Surgical Table Cushion

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