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510(k) Data Aggregation

    K Number
    K963354
    Device Name
    5 STAR MEDICAL ENDOSCOPE
    Manufacturer
    FIVE STAR MEDICAL, INC.
    Date Cleared
    1997-09-08

    (378 days)

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

    FIVE STAR MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Direct Visualization of B.I. - B.U. System using additional accessories to perform various diagnostic and therapeutic procedure.
    Device Description
    A description of the endoscopes' components is as follows: Optical Catheters, Optical Handle, Fiber Optic Cables, Adapters and Light Sources.
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    K Number
    K960876
    Device Name
    FIVE STAR BRONCHOSCOPE
    Manufacturer
    FIVE STAR MEDICAL, INC.
    Date Cleared
    1996-05-08

    (65 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIVE STAR MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 5 Star Medical bronchoscope is intended for use in the direct visualization and diagnosis in the trachea and lungs.
    Device Description
    A description of the Bronchoscope's components is as follows: Optical Catheters, Optical Handle, Fiber Optic Cables, Adapters and Light Sources.
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