BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    ELMED PNEUMOPERITONEUM NEEDLES

    K Number: K943624 · Decision Aug 10, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    14
    Applicant Total
    6
    Review Days
    15

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    Basic Information

    Device Name
    ELMED PNEUMOPERITONEUM NEEDLES
    K Number
    K943624
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Henke-Sass, Wolf GmbH
    Date Received
    July 26, 1994
    Decision Date
    August 10, 1994
    Product Code
    FHO
    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
    FHO Pneumoperitoneum Needle

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