BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CR-39 TYPE RESIN

    K Number: K850905 · Decision Mar 20, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    602
    Registration Numbers
    602
    Same Product Code
    55
    Applicant Total
    1
    Review Days
    15

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    Basic Information

    Device Name
    CR-39 TYPE RESIN
    K Number
    K850905
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5844
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Orplex Corp.
    Date Received
    March 5, 1985
    Decision Date
    March 20, 1985
    Product Code
    HQG
    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
    HQG Lens, Spectacle, Non-Custom (Prescription)

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