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

    SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING

    K Number: K062569 · Decision Feb 14, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    186
    Registration Numbers
    186
    Same Product Code
    203
    Applicant Total
    136
    Review Days
    167

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    Basic Information

    Device Name
    SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING
    K Number
    K062569
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.4450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Datascope Corp.
    Date Received
    August 31, 2006
    Decision Date
    February 14, 2007
    Product Code
    DXC
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DXC Clamp, Vascular

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