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

    FRAGMATOME MODEL 820

    K Number: K771644 · Decision Sep 26, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    4
    Review Days
    28

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    Basic Information

    Device Name
    FRAGMATOME MODEL 820
    K Number
    K771644
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Berkeley Bio-Engineering
    Date Received
    August 29, 1977
    Decision Date
    September 26, 1977
    Product Code
    HQC
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HQC Unit, Phacofragmentation

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    Other Clearances by Berkeley Bio-Engineering

    K Number Device Name
    K790645 ENDOTOME
    K771711 BIOTOME
    K770292 MONITOR, FETAL HEART, MODEL 1980