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

    AUTO SUTURE KERRISON SPINAL RONGEUR

    K Number: K943116 · Decision Jul 27, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    35
    Applicant Total
    218
    Review Days
    30

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    Basic Information

    Device Name
    AUTO SUTURE KERRISON SPINAL RONGEUR
    K Number
    K943116
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4840
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    United States Surgical, A Division of Tyco Healthc
    Date Received
    June 27, 1994
    Decision Date
    July 27, 1994
    Product Code
    HAE
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HAE Rongeur, Manual

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