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

    BIOSONIC ULTRASONIC CLEANING SYSTEM

    K Number: K884660 · Decision Mar 16, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    150
    Registration Numbers
    150
    Same Product Code
    18
    Applicant Total
    2
    Review Days
    129

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    Basic Information

    Device Name
    BIOSONIC ULTRASONIC CLEANING SYSTEM
    K Number
    K884660
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6150
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Whaledent Intl. Div. Ipco
    Date Received
    November 7, 1988
    Decision Date
    March 16, 1989
    Product Code
    FLG
    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
    FLG Cleaner, Ultrasonic, Medical Instrument

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