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510(k) Data Aggregation

    K Number
    K030471
    Device Name
    OPHTEC ENCLAVATION NEEDLE
    Manufacturer
    OPHTEC USA
    Date Cleared
    2003-04-17

    (64 days)

    Product Code
    HNQ, HNO
    Regulation Number
    886.4350
    Why did this record match?
    Product Code :

    HNQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An OPHTEC Enclavation Needle is a hand held, non powered, single-use ophthalmic instrument used to manipulate iris tissue during the surgical procedure to fixate an ARTISAN™ phakic or aphakic intraocular lens in a human eye.
    Device Description
    Enclavation Needles are surgical stainless steel needles that have been dulled and molded into a configuration so as to assist in tissue manipulation during ARTISAN™ Lens implant surgery. The instrument has an acrylic handle and one needle at each end. Each end is uniquely designed to create a right-hand end and a left-hand end to aid the surgeon during the procedure.
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    K Number
    K022842
    Device Name
    STEPHENS DISPOSABLE HOOKS
    Manufacturer
    STEPHENS INSTRUMENTS
    Date Cleared
    2002-11-01

    (66 days)

    Product Code
    HNQ
    Regulation Number
    886.4350
    Why did this record match?
    Product Code :

    HNQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The hook is a single use instrument for the retraction of eye muscles in various ophthalmic procedures.
    Device Description
    A single use ophthalmic device designed to retract eye muscles.
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