BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    EUREDUC PNEUMATIC DRAINAGE SYSTEM

    K Number: K954788 · Decision Oct 28, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    2
    Review Days
    376

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    Basic Information

    Device Name
    EUREDUC PNEUMATIC DRAINAGE SYSTEM
    K Number
    K954788
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eureduc
    Date Received
    October 18, 1995
    Decision Date
    October 28, 1996
    Product Code
    JOW
    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
    JOW Sleeve, Limb, Compressible

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    Other Clearances by Eureduc

    K Number Device Name
    K960902 EUREDUC PNEUMATIC DRAINAGE SYSTEM MODEL TP03