BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇿 New Zealand

    ROSE K LENS

    K Number: K945955 · Decision Feb 7, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    117
    Applicant Total
    2
    Review Days
    63

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    Basic Information

    Device Name
    ROSE K LENS
    K Number
    K945955
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rose K International , Ltd.
    Date Received
    December 6, 1994
    Decision Date
    February 7, 1995
    Product Code
    HQD
    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
    HQD Lens, Contact (Other Material) - Daily

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    Other Clearances by Rose K International , Ltd.

    K Number Device Name
    K013646 ROSE K POST GRAFT LENS