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

    NAVIJECT SUB2-1P, MODEL: LP604430

    K Number: K092023 · Decision Jul 28, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    62
    Applicant Total
    6
    Review Days
    22

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    Basic Information

    Device Name
    NAVIJECT SUB2-1P, MODEL: LP604430
    K Number
    K092023
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    886.4300
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medicel AG
    Date Received
    July 6, 2009
    Decision Date
    July 28, 2009
    Product Code
    MSS
    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
    MSS Folders And Injectors, Intraocular Lens (Iol)

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    Other Clearances by Medicel AG

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