BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DISIMETRIC RELEASE OF INSTRANETICS RAD

    K Number: K830786 · Decision May 18, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    43
    Applicant Total
    19
    Review Days
    68

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    Basic Information

    Device Name
    DISIMETRIC RELEASE OF INSTRANETICS RAD
    K Number
    K830786
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.4730
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    American Convertors Div., American Pharmaseal
    Date Received
    March 11, 1983
    Decision Date
    May 18, 1983
    Product Code
    KOA
    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
    KOA Surgical Instruments, G-U, Manual (And Accessories)

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