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

    BUSSE UMBILICAL CORD CLAMP CUTTER

    K Number: K021055 · Decision Apr 29, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    35
    Applicant Total
    31
    Review Days
    28

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    Basic Information

    Device Name
    BUSSE UMBILICAL CORD CLAMP CUTTER
    K Number
    K021055
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Busse Hospital Disposables, Inc.
    Date Received
    April 1, 2002
    Decision Date
    April 29, 2002
    Product Code
    HFW
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HFW Clamp, Umbilical

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