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

    URETHAL CUTTER CLAMP

    K Number: K820015 · Decision Feb 22, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    43
    Applicant Total
    6
    Review Days
    48

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    Basic Information

    Device Name
    URETHAL CUTTER CLAMP
    K Number
    K820015
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.4730
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Lone Star Medical Products, Inc.
    Date Received
    January 5, 1982
    Decision Date
    February 22, 1982
    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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