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

    WLP SEQUENTIAL VERSION MODEL WLP SOLO VI, WLP SOLO SEQUENTIAL

    K Number: K961292 · Decision Nov 6, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    6
    Review Days
    216

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    Basic Information

    Device Name
    WLP SEQUENTIAL VERSION MODEL WLP SOLO VI, WLP SOLO SEQUENTIAL
    K Number
    K961292
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wright Linear Pump, Inc.
    Date Received
    April 4, 1996
    Decision Date
    November 6, 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 Wright Linear Pump, Inc.

    K Number Device Name
    K071040 WRIGHT MODEL 51 AND 52 SEQUENTIAL COMPRESSION SYSTEMS
    K961891 WLP SINGLE-SEGMENT VERSION WLP SOLO VII
    K961797 WLP GRADIENT SEQUENTIAL VERSION/WLP PROLITE/WLP WLP-II LITE
    K883186 WRIGHT GRADIENT PRESSURE SUPPORT STOCKINGS
    K830577 LINEAR PUMP #4370975