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510(k) Data Aggregation

    K Number
    K972063
    Device Name
    WHITTINGHAM ULTRACLEAN PHACO HANDPIECE
    Manufacturer
    WILLIAM F. WHITTINGHAM
    Date Cleared
    1997-11-25

    (175 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    WILLIAM F. WHITTINGHAM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Whittingham UltraClean Phaco Handpiece is indicated for surgical removal of cataract tissues or other unwanted eye tissue.
    Device Description
    The Whittingham UltraClean Phaco Handpiece is a phacoemulsification handpiece, for use with standard, disposable phaccemulsification needles, a 39 to 55 KHz Piezoelectric driver module, and the associated ophthalmic surgical system control units. A handpiece such as this is used in ophthalmic surgery to break up (emulsify) and remove unwanted or degenerative tissues, such as cataract tissue.
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