BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536

    K Number: K072216 · Decision Nov 9, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    109
    Applicant Total
    9
    Review Days
    92

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    Basic Information

    Device Name
    KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536
    K Number
    K072216
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kapp Surgical Instrument, Inc.
    Date Received
    August 9, 2007
    Decision Date
    November 9, 2007
    Product Code
    NEU
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NEU Marker, Radiographic, Implantable

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    K050657 MONDEAL CONTOUR HO SYSTEM
    K033930 KAPP CUSTOM ULNAR HEAD WRIST IMPLANT
    K030237 KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT
    K844177 COSGROVE MITRAL VALVE RETRACTOR
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