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

    DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES

    K Number: K090979 · Decision May 28, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    10
    Review Days
    51

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    Basic Information

    Device Name
    DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES
    K Number
    K090979
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Encision, Inc.
    Date Received
    April 7, 2009
    Decision Date
    May 28, 2009
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    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
    GCJ Laparoscope, General & Plastic Surgery

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