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510(k) Data Aggregation

    K Number
    K972252
    Device Name
    VISTA UNIVERSAL HANDPIECE
    Date Cleared
    1997-07-29

    (43 days)

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

    ODYSSEY TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For use in cataract surgery to disrupt a cataract with ultrasound through emulsification and extract the cataract.
    Device Description
    Not Found
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    K Number
    K972253
    Device Name
    P3 UNIVERSAL PHACO HANDPIECE
    Date Cleared
    1997-07-29

    (43 days)

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

    ODYSSEY TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For use in cataract surgery to disrupt a cataract with ultrasound through emulsification and extract the cataract.
    Device Description
    Odyssey Technologies P3 Universal Handpiece
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