BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFAB

    K Number: K070457 · Decision May 16, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    236
    Registration Numbers
    236
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    89

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    Basic Information

    Device Name
    SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFAB
    K Number
    K070457
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5075
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sun Scientific, LLC
    Date Received
    February 16, 2007
    Decision Date
    May 16, 2007
    Product Code
    MHW
    Advisory Committee
    General Hospital
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MHW Dressing, Compression

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