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

    GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING

    K Number: K001125 · Decision Oct 4, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    180

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    Basic Information

    Device Name
    GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING
    K Number
    K001125
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4300
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Geuder GmbH
    Date Received
    April 7, 2000
    Decision Date
    October 4, 2000
    Product Code
    NCE
    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
    NCE Injector, Capsular Tension Ring

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