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    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES

    K Number: K113062 · Decision Aug 21, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    312

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    Basic Information

    Device Name
    ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES
    K Number
    K113062
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Endoservice Optical Instruments GmbH
    Date Received
    October 14, 2011
    Decision Date
    August 21, 2012
    Product Code
    FBP
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FBP Telescope, Rigid, Endoscopic

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