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

    URIAS PRESSURE SPLINTS, & FIRST AID

    K Number: K831764 · Decision Sep 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    103

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    Basic Information

    Device Name
    URIAS PRESSURE SPLINTS, & FIRST AID
    K Number
    K831764
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.3900
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Svenol Andersen
    Date Received
    June 1, 1983
    Decision Date
    September 12, 1983
    Product Code
    FZF
    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
    FZF Splint, Extremity, Inflatable, External

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