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

    RIGID GAS PERMEABLE CONTACT LENS SOLUTION

    K Number: K011945 · Decision Sep 12, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    117
    Applicant Total
    23
    Review Days
    83

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    Basic Information

    Device Name
    RIGID GAS PERMEABLE CONTACT LENS SOLUTION
    K Number
    K011945
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Polymer Technology Corp.
    Date Received
    June 21, 2001
    Decision Date
    September 12, 2001
    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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