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510(k) Data Aggregation

    K Number
    K945105
    Device Name
    POLY/PLATINUM WIRE PISTON
    Date Cleared
    1996-05-14

    (574 days)

    Product Code
    Regulation Number
    874.3450
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROMED DEVELOPMENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Poly/Platinum Pistons are intended for the elective reconstruction of the ossicular chain to facilitate conduction of sound energy from the ear drum to the inner ear. The prosthesis is implanted into the middle ear during a tympanoplasty procedure and is retained in the middle ear by the design configuration of the device.
    Device Description
    Poly/Platinum Pistons are implants for middle ear reconstruction. Available in a range of shaft diameters and lengths with loops for ossicular attachment. The device is a single patient use only implant, labeled as a restricted device for use only by a qualified health care professional and is individually sterile packaged, contained in a carton provided with an Important Product Information insert for the physician.
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