BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    THE BIBICURE SYS BREAST TONER

    K Number: K843544 · Decision Jan 25, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    91
    Registration Numbers
    91
    Same Product Code
    26
    Applicant Total
    2
    Review Days
    140

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    Basic Information

    Device Name
    THE BIBICURE SYS BREAST TONER
    K Number
    K843544
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    884.5150
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Les Entreprises Bibi, Inc.
    Date Received
    September 7, 1984
    Decision Date
    January 25, 1985
    Product Code
    HGY
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HGY Pump, Breast, Non-Powered

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    Other Clearances by Les Entreprises Bibi, Inc.

    K Number Device Name
    K843543 THE BIBICURE SYS DERMEPIL NATURAL HAIR