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

    REPROCESSED COMPRESSION SLEEVES

    K Number: K060049 · Decision Feb 24, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    36
    Review Days
    49

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    Basic Information

    Device Name
    REPROCESSED COMPRESSION SLEEVES
    K Number
    K060049
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alliance Medical Corp.
    Date Received
    January 6, 2006
    Decision Date
    February 24, 2006
    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 Alliance Medical Corp.

    K Number Device Name
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    K053316 REPROCESSED COMPRESSION SLEEVES
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