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510(k) Data Aggregation

    K Number
    K972056
    Device Name
    STANDARD ENDOSCOPE
    Manufacturer
    LASER-OPTIK-SYSTEME GMBH & CO. KG
    Date Cleared
    1997-07-30

    (58 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    **LASER-OPTIK-SYSTEME GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LOS is designed for the standard endoscope use in General Surgery, especially for diagnostic in the ENT field.
    Device Description
    Standard Endoscope
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    K Number
    K950712
    Device Name
    PORTABLE ENDOSCOPY SYSTEM
    Manufacturer
    LASER-OPTIK-SYSTEME GMBH & CO. KG
    Date Cleared
    1996-05-14

    (455 days)

    Product Code
    GCM, EOB, ERA
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    **LASER-OPTIK-SYSTEME GMBH **& CO

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

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