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

    DISPOSIQUET A DISPOS. TOURNIQUET

    K Number: K840489 · Decision Mar 12, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    335
    Registration Numbers
    335
    Same Product Code
    19
    Applicant Total
    1
    Review Days
    35

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    Basic Information

    Device Name
    DISPOSIQUET A DISPOS. TOURNIQUET
    K Number
    K840489
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.5900
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Med Lab Products
    Date Received
    February 6, 1984
    Decision Date
    March 12, 1984
    Product Code
    GAX
    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
    GAX Tourniquet, Nonpneumatic

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