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

    CLASSIC 70 LENS

    K Number: K871649 · Decision May 29, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    2
    Review Days
    30

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    Basic Information

    Device Name
    CLASSIC 70 LENS
    K Number
    K871649
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Korea Asahi Optical Co., Ltd.
    Date Received
    April 29, 1987
    Decision Date
    May 29, 1987
    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 Korea Asahi Optical Co., Ltd.

    K Number Device Name
    K871961 MULTIPLE SPECTACLE LENS