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

    STEPPER

    K Number: K771539 · Decision Oct 7, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    275
    Registration Numbers
    276
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    57

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    Basic Information

    Device Name
    STEPPER
    K Number
    K771539
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6430
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Tridak
    Date Received
    August 11, 1977
    Decision Date
    October 7, 1977
    Product Code
    KYX
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KYX Dispenser, Liquid Medication

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