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

    SULKY SPECIAL

    K Number: K863450 · Decision Oct 23, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    50

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    Basic Information

    Device Name
    SULKY SPECIAL
    K Number
    K863450
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Asc Corp.
    Date Received
    September 3, 1986
    Decision Date
    October 23, 1986
    Product Code
    LBE
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LBE Stroller, Adaptive

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