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

    MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL

    K Number: K974469 · Decision Feb 24, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    61
    Review Days
    90

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    Basic Information

    Device Name
    MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL
    K Number
    K974469
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mentor Corp.
    Date Received
    November 26, 1997
    Decision Date
    February 24, 1998
    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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