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510(k) Data Aggregation

    K Number
    K090626
    Device Name
    ENDOSERTER
    Manufacturer
    OCULAR SYSTEMS, INC.
    Date Cleared
    2011-01-21

    (683 days)

    Product Code
    OTZ
    Regulation Number
    886.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    OCULAR SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EndoSerter™ is used to insert corneal endothelial allograft tissue measuring less than or equal to 8.5mm in diameter and 175 micron in central thickness into the anterior chamber through a minimum 4mm incision during endothelial keratoplasty procedures.
    Device Description
    Not Found
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