BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ULTRASONIC FRAGMENTOR

    K Number: K813389 · Decision Feb 4, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    148
    Applicant Total
    10
    Review Days
    63

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    Basic Information

    Device Name
    ULTRASONIC FRAGMENTOR
    K Number
    K813389
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4150
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Fibra Sonics, Inc.
    Date Received
    December 3, 1981
    Decision Date
    February 4, 1982
    Product Code
    HQE
    Advisory Committee
    Ophthalmic
    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
    HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered

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    K980930 FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA
    K842024 ULTRASONIC LITHOTRIPTOR 300A
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    K812909 HYGIENTIST; CYCLOSON I & II; RETROFIT
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