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510(k) Data Aggregation

    K Number
    K970917
    Device Name
    SOLOS 10MM OPERATING LAPAROSCOPE
    Date Cleared
    1997-06-10

    (90 days)

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

    WOODBINE OPTICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    to allow surgeons to view the interior cavities of the human body under direct vision through the scope for the purpose of performing surgery by general surgeons and thoracic surgeons.
    Device Description
    Solos 10mm Operating Laparoscope
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    K Number
    K970056
    Device Name
    SOLOS, CIDEO CAMERA REPLACEMENT CABLE, 800/900 SERIES
    Date Cleared
    1997-01-28

    (21 days)

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

    WOODBINE OPTICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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