BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS

    K Number: K081877 · Decision Jan 5, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    4
    Review Days
    187

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    Basic Information

    Device Name
    ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS
    K Number
    K081877
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dutch Ophthalmic Research Center International BV
    Date Received
    July 2, 2008
    Decision Date
    January 5, 2009
    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 Dutch Ophthalmic Research Center International BV

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