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510(k) Data Aggregation

    K Number
    K042478
    Device Name
    CAPSULE TENSION RING INSERTER, MODEL 7-810
    Manufacturer
    DUCKWORTH & KENT, LTD.
    Date Cleared
    2004-12-28

    (106 days)

    Product Code
    NCE
    Regulation Number
    886.4300
    Why did this record match?
    Product Code :

    NCE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    When a "Morcher Capsular Tension Ring" is to be implanted as part of a cataract procedure. This injector will facilitate the insertion and proper placement of the ring in the capsular bag.
    Device Description
    Not Found
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    K Number
    K011498
    Device Name
    EASY CONTROL MICRO INSERTER, MODEL ON385
    Manufacturer
    OPHTEC USA, INC.
    Date Cleared
    2001-07-09

    (55 days)

    Product Code
    NCE
    Regulation Number
    886.4300
    Why did this record match?
    Product Code :

    NCE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001125
    Device Name
    GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING
    Manufacturer
    GEUDER GMBH
    Date Cleared
    2000-10-04

    (180 days)

    Product Code
    NCE
    Regulation Number
    886.4300
    Why did this record match?
    Product Code :

    NCE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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