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510(k) Data Aggregation

    K Number
    K030857
    Device Name
    MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND ENDOSCOPIC ACCESSORIES
    Manufacturer
    MAHE INTL., INC.
    Date Cleared
    2003-10-16

    (212 days)

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

    MAHE INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MAHE Pediatric Naso-Pharyngoscope is intended for use only by qualified surgeons. Do not use the instrument for any purpose other than its intended application. The MAHE Pediatric Naso-Pharyngoscope has been designed to be used with a light source, documentation equipment and video monitor for sinuscopy diagnosis and treatment within the nasal cavity and nasal pharynx. The MAHE Pediatric Naso-Pharyngoscope is indicated for visual exam during diagnostic and therapeutic procedure within the nasal cavity and nasal pharynx. The MAHE International Pediatric NASOPHARYNGOSCOPE is indicated for visual examination during a diagnostic and therapeutic procedure within the nasal cavity and nasal pharynx.
    Device Description
    The MAHE Pediatric Naso-Pharyngoscope has been designed to be used with a light source, documentation equipment and video monitor for sinuscopy diagnosis and treatment within the nasal cavity and nasal pharynx.
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    K Number
    K991426
    Device Name
    MAHE INSTRUMENTS
    Manufacturer
    MAHE INTL., INC.
    Date Cleared
    1999-08-05

    (104 days)

    Product Code
    FDC, FAS, FJL
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAHE INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE INTENDED USE FOR THE RESECTOSCOPE AND WORKING ELEMENTS IS IN UROLOGICAL PROCEDURES TO ENDOSCOPICALLY REMOVE, CUT, COAGULATE, AND OR TRANSECT TISSUE IN THE BLADDER, PROSTRATE, AND URETHRA. THE SURGEON PERFORMS THE EXAMINATION THROUGH THE URETHRA. THE DOCTOR CONTROLS THE BACK AND FORTH MOVEMENT OF THE ELECTRODE USING FINGER CONTROLS. THE WORKING ELEMENTS ALSO HOUSE A CYSTOSCOPE FOR VISALIZATION. THE HIGH FREQUENCY CABLE TRANSMITS ELECTRICAL CURRENT
    Device Description
    The Resectoscope is a reuasble non sterile urological instrument used with disposable sterile, single use electrodes for electro-cautery. The sheath and electrodes will be marketed in 24-27 French sizes.
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