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510(k) Data Aggregation

    K Number
    K013151
    Device Name
    ASMOTOM AUTOMATED TREPHINE SYSTEM
    Manufacturer
    BKG OPTHALMICS USA, INC.
    Date Cleared
    2001-12-14

    (85 days)

    Product Code
    HRG
    Regulation Number
    886.4070
    Why did this record match?
    Applicant Name (Manufacturer) :

    BKG OPTHALMICS USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ASMOTOM Automated Trephine System is intended to perform penetrating cuts of the central portion of the cornea. The Primary and only purpose of this device is to produce cuts necessary for the corneal transplantation.
    Device Description
    Not Found
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