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

    HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES

    K Number: K010448 · Decision May 16, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    88
    Applicant Total
    10
    Review Days
    90

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    Basic Information

    Device Name
    HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES
    K Number
    K010448
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Horizons Intl. Corp.
    Date Received
    February 15, 2001
    Decision Date
    May 16, 2001
    Product Code
    FBK
    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
    FBK Endoscopic Injection Needle, Gastroenterology-Urology

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