BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇧 United Kingdom

    DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2

    K Number: K072985 · Decision Jun 20, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    38
    Applicant Total
    6
    Review Days
    241

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    Basic Information

    Device Name
    DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2
    K Number
    K072985
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4300
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Duckworth & Kent, Ltd.
    Date Received
    October 23, 2007
    Decision Date
    June 20, 2008
    Product Code
    KYB
    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
    KYB Lens, Guide, Intraocular

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    Other Clearances by Duckworth & Kent, Ltd.

    K Number Device Name
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    K053176 DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797
    K042478 CAPSULE TENSION RING INSERTER, MODEL 7-810
    K024072 DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM