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

    BYPASS COIL

    K Number: K811068 · Decision May 27, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    195
    Registration Numbers
    195
    Same Product Code
    24
    Applicant Total
    56
    Review Days
    40

    Basic Information

    Device Name
    BYPASS COIL
    K Number
    K811068
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.6500
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    G.D. SEARLE AND CO.
    Date Received
    April 17, 1981
    Decision Date
    May 27, 1981
    Product Code
    KPY
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KPY Shield, Protective, Personnel

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